145 results on '"Tania Bubela"'
Search Results
2. Asynchronous online focus groups for research with people living with amyotrophic lateral sclerosis and family caregivers: usefulness, acceptability and lessons learned
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Shelagh K. Genuis, Westerly Luth, Garnette Weber, Tania Bubela, and Wendy S. Johnston
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Amyotrophic lateral sclerosis ,Online focus groups ,Research design ,Patients ,Family caregivers ,Research participation ,Medicine (General) ,R5-920 - Abstract
Abstract Background People with amyotrophic lateral sclerosis (ALS) face disability- and travel-related barriers to research participation. We investigate the usefulness and acceptability of asynchronous, online focus groups (AOFGs) for research involving people affected by ALS (patients and family caregivers) and outline lessons learned. Methods The ALS Talk Project, consisting of seven AOFGs and 100 participants affected by ALS, provided context for this investigation. Hosted on the secure itracks Board™ platform, participants interacted in a threaded web forum structure. Moderators posted weekly discussion questions and facilitated discussion. Data pertaining to methodology, participant interaction and experience, and moderator technique were analyzed using itracks and NVivo 12 analytics (quantitative) and conventional content analysis and the constant-comparative approach (qualitative). Results There was active engagement within groups, with post lengths averaging 111.48 words and a complex network of branching interactions between participants. One third of participant responses included individual reflections without further interaction. Participants affirmed their co-group members, offered practical advice, and discussed shared and differing perspectives. Moderators responded to all posts, indicating presence and probing answers. AOFGs facilitated qualitative and quantitative data-gathering and flexible response to unanticipated events. Although total participation fell below 50% after 10–12 weeks, participants valued interacting with peers in an inclusive, confidential forum. Participants used a variety of personal devices, browsers, and operating systems when interacting on the online platform. Conclusions This methodological examination of AOFGs for patient-centred investigations involving people affected by ALS demonstrates their usefulness and acceptability, and advances knowledge of online research methodologies. Lessons learned include: early identification of research goals and participant needs is critical to selecting an AOFG platform; although duration longer than 10–12 weeks may be burdensome in this population, participants were positive about AOFGs; AOFGs offer real world flexibility enabling response to research challenges and opportunities; and, AOGFs can effectively foster safe spaces for sharing personal perspectives and discussing sensitive topics. With moderators playing an important role in fostering engagement, AOFGs facilitated rich data gathering and promoted reciprocity by fostering the exchange of ideas and interaction between peers. Findings may have implications for research involving other neurologically impaired and/or medically vulnerable populations.
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- 2023
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3. A perspective on life-cycle health technology assessment and real-world evidence for precision oncology in Canada
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Dean A. Regier, Samantha Pollard, Melanie McPhail, Tania Bubela, Timothy P. Hanna, Cheryl Ho, Howard J. Lim, Kelvin Chan, Stuart J. Peacock, and Deirdre Weymann
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Health technology assessment (HTA) can be used to make healthcare systems more equitable and efficient. Advances in precision oncology are challenging conventional thinking about HTA. Precision oncology advances are rapid, involve small patient groups, and are frequently evaluated without a randomized comparison group. In light of these challenges, mechanisms to manage precision oncology uncertainties are critical. We propose a life-cycle HTA framework and outline supporting criteria to manage uncertainties based on real world data collected from learning healthcare systems. If appropriately designed, we argue that life-cycle HTA is the driver of real world evidence generation and furthers our understanding of comparative effectiveness and value. We conclude that life-cycle HTA deliberation processes must be embedded into healthcare systems for an agile response to the constantly changing landscape of precision oncology innovation. We encourage further research outlining the core requirements, infrastructure, and checklists needed to achieve the goal of learning healthcare supporting life-cycle HTA.
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- 2022
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4. 'I have such a hard time hitting myself, I thought it’d be easier': perspectives of hospitalized patients on injecting drugs into vascular access devices
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Hannah L. Brooks, Ginetta Salvalaggio, Bernadette Pauly, Kathryn Dong, Tania Bubela, Marliss Taylor, and Elaine Hyshka
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Vascular access devices ,Substance-related disorders ,Hospitalization ,Harm reduction ,Patient-centered care ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Hospital patients who use drugs may require prolonged parenteral antimicrobial therapy administered through a vascular access device (VAD). Clinicians’ concerns that patients may inject drugs into these devices are well documented. However, the perspectives of patients on VAD injecting are not well described, hindering the development of informed clinical guidance. This study was conducted to elicit inpatient perspectives on the practice of injecting drugs into VADs and to propose strategies to reduce associated harms. Methods Researchers conducted a focused ethnography and completed semi-structured interviews with 25 inpatients at a large tertiary hospital in Western Canada that experiences a high rate of drug-related presentations annually. Results A few participants reported injecting into their VAD at least once, and nearly all had heard of the practice. The primary reason for injecting into a VAD was easier venous access since many participants had experienced significant vein damage from injection drug use. Several participants recognized the risks associated with injecting into VADs, and either refrained from the practice or took steps to maintain their devices while using them to inject drugs. Others were uncertain how the devices functioned and were unaware of potential harms. Conclusions VADs are important for facilitating completion of parenteral antimicrobial therapy and for other medically necessary care. Prematurely discharging patients who inject into their VAD from hospital, or discontinuing or modifying therapy, results in inequitable access to health care for a structurally vulnerable patient population. Our findings demonstrate a need for healthcare provider education and non-stigmatizing clinical interventions to reduce potential harms associated with VAD injecting. Those interventions could include providing access to specialized pain and withdrawal management, opioid agonist treatment, and harm reduction services, including safer drug use education to reduce or prevent complications from injecting drugs into VADs.
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- 2022
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5. Covid-19 threat and coping: application of protection motivation theory to the pandemic experiences of people affected by amyotrophic lateral sclerosis
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Shelagh K. Genuis, Westerly Luth, Tania Bubela, and Wendy S. Johnston
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Amyotrophic lateral sclerosis ,Covid 19 ,Pandemics ,Emergency planning ,Protective motivation theory ,Patients ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Abstract Background People with amyotrophic lateral sclerosis (ALS) are at high risk for severe outcomes from Covid-19 infection. Researchers exploring ALS and Covid-19 have focused primarily on system response and adaptation. Using Protection Motivation Theory, we investigated how people with ALS and family caregivers appraised and responded to Covid-19 threat, the ‘costs’ associated with pandemic response, and how health professionals and systems can better support people affected by ALS who are facing public health emergencies. Methods Data were drawn from the ‘ALS Talk Project,’ an asynchronous, moderated focus group study. Participants were recruited from regions across Canada. Seven groups met online over 14 weeks between January and July 2020. Fifty-three participants contributed to Covid-19 discussions. Data were qualitatively analyzed using directed content analysis and the constant-comparative approach. Results Participants learned about the Covid-19 pandemic from the media. They rapidly assessed their vulnerability and responded to Covid-19 threat by following recommendations from health authorities, information monitoring, and preparing for worst-case scenarios. Adopting protective behaviors had substantial response costs, including adaptations for medical care and home support workers, threatened access to advance care, and increased caregiver burden. Participants expressed need for ALS-specific, pandemic information from trusted health professionals and/or ALS health charities. Telemedicine introduced both conveniences and costs. Prior experience with ALS provided tools for coping with Covid-19. Threat and coping appraisal was a dynamic process involving ongoing vigilance and adaptation. Findings draw attention to the lack of emergency preparedness among participants and within health systems. Conclusions Clinicians should engage ALS patients and families in ongoing discussions about pandemic coping, strategies to mitigate response costs, care pathways in the event of Covid-19 infection, and changing information about Covid-19 variants and vaccines. Healthcare systems should incorporate flexible approaches for medical care, leveraging the benefits of telemedicine and facilitating in-person interaction as needed and where possible. Research is needed to identify strategies to mitigate response costs and to further explore the interaction between prior experience and coping. Further study is also needed to determine how communication about emergency preparedness might be effectively incorporated into clinical care for those with ALS and other medically vulnerable populations.
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- 2022
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6. Canadian newspaper coverage on harm reduction featuring bereaved mothers: A mixed methods analysis.
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Heather Morris, T Cameron Wild, Marina Giovannoni, Rebecca Haines-Saah, Jakob Koziel, Petra Schulz, Hauwa Bwala, Diane Kunyk, Tania Bubela, and Elaine Hyshka
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Medicine ,Science - Abstract
A growing body of evidence suggests that news media which includes a sympathetic portrayal of a mother bereaved by substance use can increase public support for harm reduction initiatives. However, the extent to which such news media coverage occurs in Canada is unknown, and research has not documented how the news media in Canada covers such stories. We undertook a mixed-method secondary analyses of 5681 Canadian newspaper articles on harm reduction (2000-2016). Quantitative analyses described the volume and content of harm reduction reporting featuring a mother whose child's death was related to substance use while qualitative thematic analysis provided in-depth descriptions of the discourses underlying such news reporting. Newspaper articles featuring a mother whose child's death was related to substance use were rarely published (n = 63; 1.1% of total harm reduction media coverage during the study period). Deductive content analysis of these 63 texts revealed that coverage of naloxone distribution (42.9%) and supervised drug consumption services (28.6%) were prioritized over other harm reduction services. Although harm reduction (services or policies) were advocated by the mother in most (77.8%) of these 63 texts, inductive thematic analysis of a subset (n = 52) of those articles revealed that mothers' advocacy was diminished by newspaper reporting that emphasized their experiences of grief, prioritized individual biographies over structural factors contributing to substance use harms, and created rhetorical divisions between different groups of people who use drugs (PWUD). Bereaved mothers' advocacy in support of harm reduction programs and services may be minimized in the process of reporting their stories for newspaper readers. Finding ways to report bereaved mothers' stories in ways that are inclusive of all PWUD while highlighting the role of broad, structural determinants of substance use has the potential to shift public opinion and government support in favour of these life-saving services.
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- 2023
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7. Let’s do better: public representations of COVID-19 science
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Timothy Caulfield, Tania Bubela, Jonathan Kimmelman, and Vardit Ravitsky
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science communication ,science policy ,scientific integrity ,health policy ,news media ,public health ,ethics ,Education ,Science - Abstract
COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted, and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion of public trust. Here we explore some of the key issues associated with the representations of science in the context of the COVID-19 pandemic. Many of these issues are not new. But the COVID-19 pandemic has placed a spotlight on the biomedical research process and amplified the adverse ramifications of poor public communication. We need to do better. As such, we conclude with 10 recommendations aimed at key actors involved in the communication of COVID-19 science, including government, funders, universities, publishers, media, and the research communities.
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- 2021
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8. Open drug discovery of anti-virals critical for Canada’s pandemic strategy
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Tania Bubela, E. Richard Gold, Vivek Goel, Max Morgan, Karen Mossman, Jason Nickerson, David Patrick, and Aled Edwards
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open science ,covid-19 ,pandemic preparedness ,drug discovery ,market failure ,intellectual property rights ,public private partnerships ,Education ,Science - Abstract
In the event of the current COVID-19 pandemic and in preparation for future pandemics, open science can support mission-oriented research and development, as well as commercialization. Open science shares skills and resources across sectors; avoids duplication and provides the basis for rapid and effective validation due to full transparency. It is a strategy that can adjust quickly to reflect changing incentives and priorities, because it does not rely on any one actor or sector. While eschewing patents, it can ensure high-quality drugs, low pricing, and access through existing regulatory mechanisms. Open science practices and partnerships decrease transaction costs, increase diversity of actors, reduce overall costs, open new, higher-risk/higher-impact approaches to research, and provide entrepreneurs freedom to operate and freedom to innovate. We argue that it is time to re-open science, not only in its now restricted arena of fundamental research, but throughout clinical translation. Our model and attendant recommendations map onto a strategy to accelerate discovery of novel broad-spectrum anti-viral drugs and clinical trials of those drugs, from first-in-human safety-focused trials to late stage trials for efficacy. The goal is to ensure low-cost and rapid access, globally, and to ensure that Canadians do not pay a premium for drugs developed from Canadian science.
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- 2020
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9. Application of protection motivation theory to clinical trial enrolment for pediatric chronic conditions
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Stephanie P. Brooks and Tania Bubela
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Pediatric clinical trial ,Diabetes ,Inherited retinal disease ,Stem cell therapy ,Gene therapy ,Risk communication ,Pediatrics ,RJ1-570 - Abstract
Abstract Background Parents of children living with chronic but manageable conditions hope for improved therapies or cures, including Advanced Therapy Medicinal Products (ATMPs). Multiple pediatric clinical trials for ATMPs are underway, but the risk profile of ATMPs for chronic conditions is largely unknown and likely different than for terminal pediatric illnesses. Applying Protection Motivation Theory modified to the context of pediatric ATMP clinical trial enrollment, our study analyses information needs of parents of children living with chronic manageable conditions: Type 1 Diabetes (T1D) or Inherited Retinal Diseases (IRD). Methods We conducted semi-structured interviews with 15 parents of children living with T1D and 14 parents of children living with an IRD about: a) family background and the diagnostic experience; b) awareness of gene and stem cell therapy research and clinical trials for T1D and IRD; c) information sources on trials and responses to that information; d) attitudes to trial participation, including internationally; e) understanding of trial purpose and process; and f) any experiences with trial participation. We then discussed a pediatric ATMP clinical trial information sheet, which we developed with experts. We applied directed qualitative content analysis, based on PMT, to examine the information preferences of parents in deciding whether to enrol their children in stem cell or gene therapy clinical trials. Results Parents balanced trial risks against their child’s ability to cope with the chronic condition. The better the child’s ability to cope with vision impairment or insulin management, the less likely parents were to assume trial risks. Conversely, if the child struggled with his/her vision loss, parents were more likely to be interested in trial participation, but only if the risks were low and likelihood for potential benefit was high. Conclusions Fear of adverse events as part of threat appraisal was the predominant consideration for parents in considering whether to enroll their child living with a manageable, chronic condition in a pediatric clinical trial of an ATMP. This consideration outweighed potential benefits and severity of their child’s condition. Parents called for available safety data and fulsome communication processes that would enable them to make informed decisions about clinical trial enrolment on behalf of their children.
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- 2020
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10. Social values for health technology assessment in Canada: a scoping review of hepatitis C screening, diagnosis and treatment
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Caroline O’Keefe-Markman, Kristina Dawn Lea, Christopher McCabe, Elaine Hyshka, and Tania Bubela
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Health technology assessment ,Social values ,Hepatitis C ,Screening ,Diagnosis ,Direct acting antivirals ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Background Health care system decision makers face challenges in allocating resources for screening, diagnosis and treatment of hepatitis C. Approximately 240,000 individuals are infected with the hepatitis C virus (HCV) in Canada. Populations most affected by HCV include Indigenous people, people who inject drugs, immigrants and homeless or incarcerated populations as well as those born between 1946 and 1965. Curative but expensive drug regimens of novel direct acting antivirals (DAAs) are available. We aim to identify social values from academic literature for inclusion in health technology assessments. Methods We conducted a scoping review of academic literature to identify and analyze the social values and evidence-based recommendations for screening, diagnosis and treatment of HCV in Canada. After applying inclusion/exclusion criteria, we abstracted: type of intervention(s), population(s) affected, study location, screening methods, diagnostics and treatments. We then abstracted and applied qualitative codes for social values. We extracted social value statements and clustered them into one of 4 categories: (1) equity and justice, (2) duty to provide care, (3) maximization of population benefit, and (4) individual versus community interests. Results One hundred and eighteen articles met our inclusion criteria on screening, diagnosis and treatment of HCV in Canada. Of these, 54 (45.8%) discussed screening, 4 (3.4%) discussed diagnosis and 60 (50.8%) discussed treatment options. Most articles discussed the general population and other non-vulnerable populations. Articles that discussed vulnerable populations focused on people who inject drugs. We coded 1243 statements, most of which fell into the social value categories of equity and justice, duty to provide care and maximization of population benefit. Conclusion The academic literature identified an expanded set of social values to be taken into account by resource allocation decision makers in financially constrained environments. In the context of hepatitis C, authors called for greater consideration of equity and justice and the duty to provide care in making evidence-based recommendations for screening, diagnosis and treatment for different populations and in different settings that also account for individual and community interests.
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- 2020
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11. Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness
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Melanie McPhail, Emma Weiss, and Tania Bubela
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conditional regulatory approval ,drug regulation ,oncology ,unmet medical need ,lifecycle regulation ,Medicine (General) ,R5-920 - Abstract
International drug regulators use conditional drug approval mechanisms to facilitate faster patient access to drugs based on a lower evidentiary standard typically required of drug approvals. Faster and earlier access is justified by limiting eligibility to drugs intended for serious and life-threatening diseases and by requiring post-market evidence collection to confirm clinical benefit. One such mechanism in Canada, the Notice of Compliance with Conditions (NOC/c) policy, was introduced in 1998. Today, most of the drugs approved under the NOC/c policy are for oncology indications. We analyze oncology drugs approvals under the NOC/c policy to inform discussions of two tradeoffs applied to conditional drug approvals, eligibility criteria and post-market evidence. Our analysis informs recommendations for Canada's proposed regulatory reforms approach to conditional approvals pathways. Our analysis demonstrates that under the current policy, eligibility criteria are insufficiently defined, resulting in their inconsistent application by Health Canada. Regulatory responsiveness to post-market evidence from post-market clinical trial and foreign jurisdiction regulatory decisions is slow and insufficient. In the absence of sufficient regulatory responsiveness, physicians and patients must make clinical decisions without the benefit of the best available evidence. Together, our analysis of the two core tradeoffs in Canada's conditional drug approval provides insight to inform the further development of Canada's proposed agile regulatory approach to drugs and devices that will expand the use of terms and conditions.
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- 2022
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12. Communication About End of Life for Patients Living With Amyotrophic Lateral Sclerosis: A Scoping Review of the Empirical Evidence
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Shelagh K. Genuis, Westerly Luth, Sandra Campbell, Tania Bubela, and Wendy S. Johnston
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advance care planning ,amyotrophic lateral sclerosis ,health communication ,palliative care ,terminal care ,review ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Background: Communication about end of life, including advance care planning, life-sustaining therapies, palliative care, and end-of-life options, is critical for the clinical management of amyotrophic lateral sclerosis patients. The empirical evidence base for this communication has not been systematically examined.Objective: To support evidence-based communication guidance by (1) analyzing the scope and nature of research on health communication about end of life for amyotrophic lateral sclerosis; and (2) summarizing resultant recommendations.Methods: A scoping review of empirical literature was conducted following recommended practices. Fifteen health-related and three legal databases were searched; 296 articles were screened for inclusion/exclusion criteria; and quantitative data extraction and analysis was conducted on 211 articles with qualitative analysis on a subset of 110 articles that focused primarily on health communication. Analyses summarized article characteristics, themes, and recommendations.Results: Analysis indicated a multidisciplinary but limited evidence base. Most reviewed articles addressed end-of-life communication as a peripheral focus of investigation. Generic communication skills are important; however, substantive and sufficient disease-related information, including symptom management and assistive devices, is critical to discussions about end of life. Few articles discussed communication about specific end-of-life options. Communication recommendations in analyzed articles draw attention to communication processes, style and content but lack the systematized guidance needed for clinical practice.Conclusions: This review of primary research articles highlights the limited evidence-base and consequent need for systematic, empirical investigation to inform effective communication about end of life for those with amyotrophic lateral sclerosis. This will provide a foundation for actionable, evidence-based communication guidelines about end of life. Implications for research, policy, and practice are discussed.
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- 2021
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13. Governance of a global genetic resource commons for non-commercial research: A case-study of the DNA barcode commons
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Janis Geary and Tania Bubela
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knowledge commons, genetic resources, global, heterogeneity, non-commercial research, dna barcoding ,Political institutions and public administration (General) ,JF20-2112 - Abstract
Life sciences research that uses genetic resources is increasingly collaborative and global, yet collective action remains a significant barrier to the creation and management of shared research resources. These resources include sequence data and associated metadata, and biological samples, and can be understood as a type of knowledge commons. Collective action by stakeholders to create and use knowledge commons for research has potential benefits for all involved, including minimizing costs and sharing risks, but there are gaps in our understanding of how institutional arrangements may promote such collective action in the context of global genetic resources. We address this research gap by examining the attributes of an exemplar global knowledge commons: The DNA barcode commons. DNA barcodes are short, standardized gene regions that can be used to inexpensively identify unknown specimens, and proponents have led international efforts to make DNA barcodes a standard species identification tool. Our research examined if and how attributes of the DNA barcode commons, including governance of DNA barcode resources and management of infrastructure, facilitate global participation in DNA barcoding efforts. Our data sources included key informant interviews, organizational documents, scientific outputs of the DNA barcoding community, and DNA barcode record submissions. Our research suggested that the goal of creating a globally inclusive DNA barcode commons is partially impeded by the assumption that scientific norms and expectations held by researchers in high income countries are universal. We found scientific norms are informed by a complex history of resource misappropriation and mistrust between stakeholders. DNA barcode organizations can mitigate the challenges caused by its global membership through creating more inclusive governance structures, developing norms for the community are specific to the context of DNA barcoding, and through increasing awareness and knowledge of pertinent legal frameworks.
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- 2019
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14. Identifying and understanding factors that affect the translation of therapies from the laboratory to patients: a study protocol [version 2; peer review: 2 approved]
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Manoj M. Lalu, Joshua Montroy, C. Glenn Begley, Tania Bubela, Victoria Hunniford, David Ripsman, Neil Wesch, Jonathan Kimmelman, Malcolm Macleod, David Moher, Alvin Tieu, Lindsey Sikora, and Dean A. Fergusson
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Medicine ,Science - Abstract
Background: The process of translating preclinical findings into a clinical setting takes decades. Previous studies have suggested that only 5-10% of the most promising preclinical studies are successfully translated into viable clinical applications. The underlying determinants of this low success rate (e.g. poor experimental design, suboptimal animal models, poor reporting) have not been examined in an empirical manner. Our study aims to determine the contemporary success rate of preclinical-to-clinical translation, and subsequently determine if an association between preclinical study design and translational success/failure exists. Methods: Established systematic review methodology will be used with regards to the literature search, article screening and study selection process. Preclinical, basic science studies published in high impact basic science journals between 1995 and 2015 will be included. Included studies will focus on publicly available interventions with potential clinical promise. The primary outcome will be successful clinical translation of promising therapies - defined as the conduct of at least one Phase II trial (or greater) with a positive finding. A case-control study will then be performed to evaluate the association between elements of preclinical study design and reporting and the likelihood of successful translation. Discussion: This study will provide a comprehensive analysis of the therapeutic translation from the laboratory bench to the bedside. Importantly, any association between factors of study design and the success of translation will be identified. These findings may inform future research teams attempting preclinical-to-clinical translation. Results will be disseminated to identified knowledge users that fund/support preclinical research.
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- 2020
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15. Creating a data resource: what will it take to build a medical information commons?
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Patricia A. Deverka, Mary A. Majumder, Angela G. Villanueva, Margaret Anderson, Annette C. Bakker, Jessica Bardill, Eric Boerwinkle, Tania Bubela, Barbara J. Evans, Nanibaa’ A. Garrison, Richard A. Gibbs, Robert Gentleman, David Glazer, Melissa M. Goldstein, Hank Greely, Crane Harris, Bartha M. Knoppers, Barbara A. Koenig, Isaac S. Kohane, Salvatore La Rosa, John Mattison, Christopher J. O’Donnell, Arti K. Rai, Heidi L. Rehm, Laura L. Rodriguez, Robert Shelton, Tania Simoncelli, Sharon F. Terry, Michael S. Watson, John Wilbanks, Robert Cook-Deegan, and Amy L. McGuire
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Medicine ,Genetics ,QH426-470 - Abstract
Abstract National and international public–private partnerships, consortia, and government initiatives are underway to collect and share genomic, personal, and healthcare data on a massive scale. Ideally, these efforts will contribute to the creation of a medical information commons (MIC), a comprehensive data resource that is widely available for both research and clinical uses. Stakeholder participation is essential in clarifying goals, deepening understanding of areas of complexity, and addressing long-standing policy concerns such as privacy and security and data ownership. This article describes eight core principles proposed by a diverse group of expert stakeholders to guide the formation of a successful, sustainable MIC. These principles promote formation of an ethically sound, inclusive, participant-centric MIC and provide a framework for advancing the policy response to data-sharing opportunities and challenges.
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- 2017
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16. Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic
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Dianne Nicol, Lisa Eckstein, Michael Morrison, Jacob S. Sherkow, Margaret Otlowski, Tess Whitton, Tania Bubela, Kathryn P. Burdon, Don Chalmers, Sarah Chan, Jac Charlesworth, Christine Critchley, Merlin Crossley, Sheryl de Lacey, Joanne L. Dickinson, Alex W. Hewitt, Joanne Kamens, Kazuto Kato, Erika Kleiderman, Satoshi Kodama, John Liddicoat, David A. Mackey, Ainsley J. Newson, Jane Nielsen, Jennifer K. Wagner, and Rebekah E. McWhirter
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Medicine ,Genetics ,QH426-470 - Abstract
Editorial summary Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.
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- 2017
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17. Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications
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Moses Fung, Yan Yuan, Harold Atkins, Qian Shi, and Tania Bubela
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stem cell ,clinical trial ,clinical translation ,clinical trial registry ,clinical trial publication ,stem cell tourism ,Medicine (General) ,R5-920 ,Biology (General) ,QH301-705.5 - Abstract
We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials.
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- 2017
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18. The Impact of Heterogeneity in a Global Knowledge Commons: Implications for Governance of the DNA Barcode Commons
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Janis Geary, Trish Reay, and Tania Bubela
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knowledge commons ,global ,heterogeneity ,institutional logics ,grammar of institutions ,dna barcoding ,Political institutions and public administration (General) ,JF20-2112 - Abstract
The extent of actor heterogeneity is known to influence the outcomes in natural resource commons, and scholars have recently begun addressed the impact of heterogeneity on knowledge commons creation and sustainability. There is increasing evidence to challenge the dominant theory that heterogeneity is uniformly disadvantageous, but little is known about heterogeneity in knowledge commons. Here, we analyse heterogeneity as it applies to rules for governing a knowledge commons – the DNA barcode commons. DNA barcodes are short, standardized gene regions that can be used to inexpensively identify unknown specimens, and proponents have led international efforts to make DNA barcodes a standard species identification tool. The dominant actors in the commons are researchers in diverse fields, and the global scope of barcoding means these researchers work in countries with varying levels of biodiversity, research infrastructure, and financial resources for scientific endeavours. This cultural and wealth heterogeneity among actors results in challenges for constructing and governing the commons, including its supporting infrastructure of databases and biorepositories. We interviewed participants in DNA barcoding, and collected organizational documents. We applied the grammar of institutions to identify institutional statements, and categorized each statement based on institutional logics theory. We found that institutional logics theory is an effective applied research tool to study heterogeneity in knowledge commons. Our analysis also suggested that heterogeneity is a challenge to developing shared expectations in global knowledge commons, but participants can design institutional statements to bridge gaps in expectations.
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- 2019
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19. Canada's Assisted Human Reproduction Act: Pragmatic Reforms in Support of Research
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Tania Bubela, Erika Kleiderman, Zubin Master, Ubaka Ogbogu, Vardit Ravitsky, Amy Zarzeczny, and Bartha Maria Knoppers
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assisted reproductive technologies ,regulation ,criminal law ,constitutional law ,in vitro research ,mitochondrial replacement therapy ,Medicine (General) ,R5-920 - Abstract
Canada's Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We propose tailored regulatory carve-outs for in vitro research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental in vivo interventions that are currently prohibited, such as mitochondrial replacement therapy. Our recommendations are bounded by constitutional constraints that recognize political and practical challenges in keeping oversight of this research under Federal jurisdiction, whether conducted in academic or private sectors. The proposed nuanced regulatory scheme should be overseen by a new national Agency, modeled on a blend of the Canadian Stem Cell Oversight Committee and Assisted Human Reproduction Canada.
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- 2019
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20. Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada
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Tania Bubela, Ron Boch, and Sowmya Viswanathan
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environmental concerns ,risk assessment ,streamlined review ,regulatory burden ,clinical trials ,immunotherapy ,Medicine (General) ,R5-920 - Abstract
Canadian academic and industry stakeholders are concerned about the inclusion of “virus-like particles or sub-viral particles” in the definition of New Substances Notification Regulations for Organisms (NSNR(O)) which impacts clinical cell and gene therapy and commercialization. The requirement of an independent 120 days Environment and Climate Change Canada (ECCC) review preceding a Health Canada review on quality and environmental concerns places an additional burden on Sponsors submitting clinical trial applications (CTA) and/or New Drug Submissions (NDS). A workshop initiated by CellCAN and BIOTECanada with participants from Environment and Climate Change Canada, Health Canada, the Public Health Agency of Canada and Innovation, Science and Economic Development (Ottawa, March 19, 2018) with invited stakeholders discussed approaches to streamline the environmental review process. The following main recommendations were the focus of the workshop: A regulatory policy to clarify Canadian Environmental Protection Act (CEPA)'s definition of “living organism.” This is currently defined as “a substance that is an animate product of biotechnology.” A regulatory policy could potentially exempt “human cells touched by biotechnology for use in human medicinal products” from this definition to clarify any unintended overreach of CEPA, particularly as it applies to non-genetically modified cell therapies.A guidance document to better interpret NSNR(O) Schedule 1 requirements by CTA/NDS sponsors to satisfy the environmental review process.An amendment at the level of regulations, to the NSNR (O) to create a deferment to postpone environmental assessment of micro-organisms used in the manufacturing during investigational clinical trials (pre-market stage). The regulations would apply at the time of market authorization evaluation and review, when sufficient clinical data on vector shedding has been collected, as part of the investigational clinical trials.Amendment to Schedule 4 of the CEPA to include the Food and Drugs Act and Regulations (Food and Drugs Act /FDR) as an exclusion to the application of CEPA. This would remove the current dual regulation of cell and gene therapies by both CEPA and Food and Drugs Act /FDR.These recommendations and other options were discussed at the workshop. These recommendations if adopted will significantly streamline the current regulatory burden and harmonize environmental assessment requirements with other jurisdictions.
- Published
- 2019
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21. Provenance and risk in transfer of biological materials.
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Jane Nielsen, Tania Bubela, Don R C Chalmers, Amber Johns, Linda Kahl, Joanne Kamens, Charles Lawson, John Liddicoat, Rebekah McWhirter, Ann Monotti, James Scheibner, Tess Whitton, and Dianne Nicol
- Subjects
Biology (General) ,QH301-705.5 - Abstract
Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.
- Published
- 2018
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22. Reproducibility and Reuse of Adaptive Immune Receptor Repertoire Data
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Felix Breden, Eline T. Luning Prak, Bjoern Peters, Florian Rubelt, Chaim A. Schramm, Christian E. Busse, Jason A. Vander Heiden, Scott Christley, Syed Ahmad Chan Bukhari, Adrian Thorogood, Frederick A. Matsen IV, Yariv Wine, Uri Laserson, David Klatzmann, Daniel C. Douek, Marie-Paule Lefranc, Andrew M. Collins, Tania Bubela, Steven H. Kleinstein, Corey T. Watson, Lindsay G. Cowell, Jamie K. Scott, and Thomas B. Kepler
- Subjects
B-cell receptors ,T-cell receptors ,data sharing ,immunogenetics ,community standards ,high-throughput sequencing ,Immunologic diseases. Allergy ,RC581-607 - Abstract
High-throughput sequencing (HTS) of immunoglobulin (B-cell receptor, antibody) and T-cell receptor repertoires has increased dramatically since the technique was introduced in 2009 (1–3). This experimental approach explores the maturation of the adaptive immune system and its response to antigens, pathogens, and disease conditions in exquisite detail. It holds significant promise for diagnostic and therapy-guiding applications. New technology often spreads rapidly, sometimes more rapidly than the understanding of how to make the products of that technology reliable, reproducible, or usable by others. As complex technologies have developed, scientific communities have come together to adopt common standards, protocols, and policies for generating and sharing data sets, such as the MIAME protocols developed for microarray experiments. The Adaptive Immune Receptor Repertoire (AIRR) Community formed in 2015 to address similar issues for HTS data of immune repertoires. The purpose of this perspective is to provide an overview of the AIRR Community’s founding principles and present the progress that the AIRR Community has made in developing standards of practice and data sharing protocols. Finally, and most important, we invite all interested parties to join this effort to facilitate sharing and use of these powerful data sets (join@airr-community.org).
- Published
- 2017
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23. More Haste, Less Speed: Could Public–Private Partnerships Advance Cellular Immunotherapies?
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Tania Bubela, Katherine Bonter, Silvy Lachance, Jean-Sébastien Delisle, and E. Richard Gold
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cellular immunotherapy ,cancer ,adoptive cellular transfer ,CAR-T cell ,public–private partnerships ,Collaborative Research and Development Agreements ,Medicine (General) ,R5-920 - Abstract
Cellular immunotherapies promise to transform cancer care. However, they must overcome serious challenges, including: (1) the need to identify and characterize novel cancer antigens to expand the range of therapeutic targets; (2) the need to develop strategies to minimize serious adverse events, such as cytokine release syndrome and treatment-related toxicities; and (3) the need to develop efficient production/manufacturing processes to reduce costs. Here, we discuss whether these challenges might better be addressed through forms of public–private research collaborations, including public–private partnerships (PPPs), or whether these challenges are best addressed by way of standard market transactions. We reviewed 14 public–private relationships and 25 underlying agreements for the clinical development of cancer cellular immunotherapies in the US. Most were based on bilateral research agreements and pure market transactions in the form of service contracts and technology licenses, which is representative of the commercialization focus of the field. We make the strategic case that multiparty PPPs may better advance cancer antigen discovery and characterization and improved cell processing/manufacturing and related activities. In the rush toward the competitive end of the translational continuum for cancer cellular immunotherapy and the attendant focus on commercialization, many gaps have appeared in our understanding of cellular biology, immunology, and bioengineering. We conclude that the model of bilateral agreements between leading research institutions and the private sector may be inadequate to efficiently harness the interdisciplinary skills and knowledge of the public and private sectors to bring these promising therapies to the clinic for the benefit of cancer patients.
- Published
- 2017
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24. Experiences in Broker-Facilitated Participatory Cross-Cultural Research
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Stephanie P. Kowal, Tania Bubela, and Cynthia Jardine
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Social sciences (General) ,H1-99 - Abstract
Health researchers are increasingly using community-based participatory research approaches because of the benefits accrued through ongoing community engagement. The documentation of our research partnership highlights key ethical and analytical challenges researchers face in participatory research, particularly in projects partnering with service providers or cultural brokers in cross-cultural settings. In this article, we describe how choices made to accommodate a participatory research approach in the examination of vaccination behavior impacted the process and outcomes of our qualitative inquiries. First, we found that employing multiple interviewers influenced the breadth of discussion topics, thus reducing the ability to achieve saturation in small study populations. This was mitigated by (a) having two people at each interview and (b) using convergent interviewing, a technique in which multiple interviewers discuss and include concepts raised in interviews in subsequent interviews to test the validity of interview topics. Second, participants were less engaged during the informed consent process if they knew the interviewer before the interview commenced. Finally, exposing identity traits, such as age or immigration status, before the interview affected knowledge cocreation, as the focus of the conversation then mirrored those traits. For future research, we provide recommendations to reduce ethical and analytical concerns that arise with qualitative interview methods in participatory research. Specifically, we provide guidance to ensure ethical informed consent processes and rigorous interview techniques.
- Published
- 2017
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25. Access and benefits sharing of genetic resources and associated traditional knowledge in northern Canada: understanding the legal environment and creating effective research agreements
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Janis Geary, Cynthia G. Jardine, Jenilee Guebert, and Tania Bubela
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northern Canada ,access and benefits sharing ,genetic resources ,research agreements ,Arctic medicine. Tropical medicine ,RC955-962 - Abstract
Background. Research in northern Canada focused on Aboriginal peoples has historically benefited academia with little consideration for the people being researched or their traditional knowledge (TK). Although this attitude is changing, the complexity of TK makes it difficult to develop mechanisms to preserve and protect it. Protecting TK becomes even more important when outside groups become interested in using TK or materials with associated TK. In the latter category are genetic resources, which may have commercial value and are the focus of this article. Objective. This article addresses access to and use of genetic resources and associated TK in the context of the historical power-imbalances in research relationships in Canadian north. Design. Review. Results. Research involving genetic resources and TK is becoming increasingly relevant in northern Canada. The legal framework related to genetic resources and the cultural shift of universities towards commercial goals in research influence the environment for negotiating research agreements. Current guidelines for research agreements do not offer appropriate guidelines to achieve mutual benefit, reflect unequal bargaining power or take the relationship between parties into account. Conclusions. Relational contract theory may be a useful framework to address the social, cultural and legal hurdles inherent in creating research agreements.
- Published
- 2013
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26. Use and misuse of material transfer agreements: lessons in proportionality from research, repositories, and litigation.
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Tania Bubela, Jenilee Guebert, and Amrita Mishra
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Biology (General) ,QH301-705.5 - Abstract
Material transfer agreements exist to facilitate the exchange of materials and associated data between researchers as well as to protect the interests of the researchers and their institutions. But this dual mandate can be a source of frustration for researchers, creating administrative burdens and slowing down collaborations. We argue here that in most cases in pre-competitive research, a simple agreement would suffice; the more complex agreements and mechanisms for their negotiation should be reserved for cases where the risks posed to the institution and the potential commercial value of the research reagents is high.
- Published
- 2015
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27. Reflections on the cost of 'low-cost' whole genome sequencing: framing the health policy debate.
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Timothy Caulfield, Jim Evans, Amy McGuire, Christopher McCabe, Tania Bubela, Robert Cook-Deegan, Jennifer Fishman, Stuart Hogarth, Fiona A Miller, Vardit Ravitsky, Barbara Biesecker, Pascal Borry, Mildred K Cho, June C Carroll, Holly Etchegary, Yann Joly, Kazuto Kato, Sandra Soo-Jin Lee, Karen Rothenberg, Pamela Sankar, Michael J Szego, Pilar Ossorio, Daryl Pullman, Francois Rousseau, Wendy J Ungar, and Brenda Wilson
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Biology (General) ,QH301-705.5 - Abstract
The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.
- Published
- 2013
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28. When pictures waste a thousand words: analysis of the 2009 H1N1 pandemic on television news.
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Westerly Luth, Cindy Jardine, and Tania Bubela
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Medicine ,Science - Abstract
ObjectivesEffective communication by public health agencies during a pandemic promotes the adoption of recommended health behaviours. However, more information is not always the solution. Rather, attention must be paid to how information is communicated. Our study examines the television news, which combines video and audio content. We analyse (1) the content of television news about the H1N1 pandemic and vaccination campaign in Alberta, Canada; (2) the extent to which television news content conveyed key public health agency messages; (3) the extent of discrepancies in audio versus visual content.MethodsWe searched for "swine flu" and "H1N1" in local English news broadcasts from the CTV online video archive. We coded the audio and visual content of 47 news clips during the peak period of coverage from April to November 2009 and identified discrepancies between audio and visual content.ResultsThe dominant themes on CTV news were the vaccination rollout, vaccine shortages, long line-ups (queues) at vaccination clinics and defensive responses by public health officials. There were discrepancies in the priority groups identified by the provincial health agency (Alberta Health and Wellness) and television news coverage as well as discrepancies between audio and visual content of news clips. Public health officials were presented in official settings rather than as public health practitioners.ConclusionThe news footage did not match the main public health messages about risk levels and priority groups. Public health agencies lost control of their message as the media focused on failures in the rollout of the vaccination campaign. Spokespeople can enhance their local credibility by emphasizing their role as public health practitioners. Public health agencies need to learn from the H1N1 pandemic so that future television communications do not add to public confusion, demonstrate bureaucratic ineffectiveness and contribute to low vaccination rates.
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- 2013
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29. Identifying and understanding factors that affect the translation of therapies from the laboratory to patients: a study protocol [version 1; peer review: 1 approved, 1 approved with reservations]
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Manoj M. Lalu, Joshua Montroy, C. Glenn Begley, Tania Bubela, Victoria Hunniford, David Ripsman, Neil Wesch, Jonathan Kimmelman, Malcolm Macleod, David Moher, Alvin Tieu, Lindsey Sikora, and Dean A. Fergusson
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Study Protocol ,Articles ,Translational failures ,promising therapies ,bench-to-bedside research ,systematic review ,case-control study - Abstract
Background: The process of translating preclinical findings into a clinical setting takes decades. Previous studies have suggested that only 5-10% of the most promising preclinical studies are successfully translated into viable clinical applications. The underlying determinants of this low success rate (e.g. poor experimental design, suboptimal animal models, poor reporting) have not been examined in an empirical manner. Our study aims to determine the contemporary success rate of preclinical-to-clinical translation, and subsequently determine if an association between preclinical study design and translational success/failure exists. Methods: Established systematic review methodology will be used with regards to the literature search, article screening and study selection process. Preclinical, basic science studies published in high impact basic science journals between 1995 and 2015 will be included. Included studies will focus on publicly available interventions with potential clinical promise. The primary outcome will be successful clinical translation of promising therapies - defined as the conduct of at least one Phase II trial (or greater) with a positive finding. A case-control study will then be performed to evaluate the association between elements of preclinical study design and reporting and the likelihood of successful translation. Discussion: This study will provide a comprehensive analysis of the therapeutic translation from the laboratory bench to the bedside. Importantly, any association between factors of study design and the success of translation will be identified. These findings may inform future research teams attempting preclinical-to-clinical translation. Results will be disseminated to identified knowledge users that fund/support preclinical research.
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- 2020
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30. Can Managed Access Agreements Mitigate Evidentiary, Economic and Ethical Issues with Access to Expensive Drugs for Rare Diseases in the Canadian Context?
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Melanie McPhail and Tania Bubela
- Subjects
General Medicine - Published
- 2023
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31. The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
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Melanie, McPhail, Christopher, McCabe, Dean A, Regier, and Tania, Bubela
- Subjects
Canada ,Insurance, Health ,COVID-19 ,Humans ,Drug Approval ,BNT162 Vaccine - Abstract
Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertaking to conduct post-market clinical trials that address evidentiary uncertainties, relying on the collection and analysis of post-market data. In practice, however, both conditional regulatory and reimbursement decisions have proven problematic. Here we discuss some of the regulatory implications and unsettled ethical and pragmatic issues, taking lessons from the recent experiences of Israel in rapidly approving the Pfizer-BioNTech COVID-19 vaccine.
- Published
- 2022
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32. Lessons from Canada’s notice of compliance with conditions policy for the life-cycle regulation of drugs
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Melanie McPhail, Howard Zhang, Zohra Bhimani, and Tania Bubela
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Medicine (miscellaneous) ,Law ,Biochemistry, Genetics and Molecular Biology (miscellaneous) - Abstract
Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c) policy from 1998 to 2021 to analyze its function, identify challenges and areas for improvement, and make recommendations to inform Health Canada’s regulatory reforms. We analyzed a sample of 148 drugs authorized between 1998 and 2021, including characteristics about the pre- and post-market clinical trials, finding that most NOC/c authorizations are based on one, single-arm clinical trial using a surrogate endpoint. Post-market trials are more likely to be randomized, Phase III trials but mostly use surrogate endpoints. Based on our findings, we recommend increasing decision-making transparency throughout the regulatory process, developing comprehensive eligibility criteria for selecting appropriate health technologies, modernizing pre-market evidence requirements, adopting a more active role in designing post-market trials, and utilizing automatic expiry, stronger penalties, and ongoing disclosure of the status of post-market trials to promote compliance.
- Published
- 2023
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33. Author name disambiguation for collaboration network analysis and visualization.
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Andreas Strotmann, Dangzhi Zhao, and Tania Bubela
- Published
- 2009
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34. Amyotrophic lateral sclerosis (ALS) health charities are central to ALS care: perspectives of Canadians affected by ALS
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Mira Ahmad, Shelagh K. Genuis, Westerly Luth, Tania Bubela, and Wendy S. Johnston
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Neurology ,Neurology (clinical) - Published
- 2022
35. Let’s do better: public representations of COVID-19 science
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Vardit Ravitsky, Jonathan Kimmelman, Timothy Caulfield, and Tania Bubela
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medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Science ,news media ,01 natural sciences ,Education ,03 medical and health sciences ,0302 clinical medicine ,Political science ,Pandemic ,medicine ,Science communication ,030212 general & internal medicine ,0101 mathematics ,Health policy ,News media ,Pace ,Multidisciplinary ,business.industry ,Public health ,public health ,010102 general mathematics ,health policy ,Public relations ,science communication ,ethics ,science policy ,scientific integrity ,Science policy ,business - Abstract
COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted, and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion of public trust. Here we explore some of the key issues associated with the representations of science in the context of the COVID-19 pandemic. Many of these issues are not new. But the COVID-19 pandemic has placed a spotlight on the biomedical research process and amplified the adverse ramifications of poor public communication. We need to do better. As such, we conclude with 10 recommendations aimed at key actors involved in the communication of COVID-19 science, including government, funders, universities, publishers, media, and the research communities.
- Published
- 2021
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36. Public Engagement
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Tania Bubela, Katie Fenn, Sally Greenwood, Anne-Marie Nicol, Beverly Pomeroy, Harlan Pruden, Emily Rempel, and Alice Virani
- Published
- 2022
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37. CAPTURE ALS: the comprehensive analysis platform to understand, remedy and eliminate ALS
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Vincent Picher-Martel, Claire Magnussen, Mathieu Blais, Tania Bubela, Samir Das, Annie Dionne, Alan C. Evans, Angela Genge, Russell Greiner, Yasser Iturria-Medina, Wendy Johnston, Kelvin Jones, Hannah Kaneb, Jason Karamchandani, Sara Moradipoor, Janice Robertson, Ekaterina Rogaeva, David M. Taylor, Christine Vande Velde, Yana Yunusova, Lorne Zinman, Sanjay Kalra, and Nicolas Dupré
- Subjects
Neurology ,Neurology (clinical) - Abstract
The absence of disease modifying treatments for amyotrophic lateral sclerosis (ALS) is in large part a consequence of its complexity and heterogeneity. Deep clinical and biological phenotyping of people living with ALS would assist in the development of effective treatments and target specific biomarkers to monitor disease progression and inform on treatment efficacy. The objective of this paper is to present the Comprehensive Analysis Platform To Understand Remedy and Eliminate ALS (CAPTURE ALS), an open and translational platform for the scientific community currently in development. CAPTURE ALS is a Canadian-based platform designed to include participants' voices in its development and through execution. Standardized methods will be used to longitudinally characterize ALS patients and healthy controls through deep clinical phenotyping, neuroimaging, neurocognitive and speech assessments, genotyping and multisource biospecimen collection. This effort plugs into complementary Canadian and international initiatives to share common resources. Here, we describe in detail the infrastructure, operating procedures, and long-term vision of CAPTURE ALS to facilitate and accelerate translational ALS research in Canada and beyond.
- Published
- 2022
38. Do-It-Yourself and Commercial Automated Insulin Delivery Systems in Type 1 Diabetes: An Uncertain Area for Canadian Health-care Providers
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Amy E. Morrison, Peter A. Senior, Tania Bubela, Kate Farnsworth, Holly O. Witteman, and Anna Lam
- Subjects
Endocrinology ,Endocrinology, Diabetes and Metabolism ,Internal Medicine ,General Medicine - Abstract
In the past century, since the discovery of insulin, methods of insulin delivery and glucose monitoring have advanced technologically. In particular, the introduction of insulin pumps, providing continuous subcutaneous insulin infusion (CSII), and continuous glucose monitors (CGMs) have been revolutionary for people living with type 1 diabetes. In this review, we have focussed on automated insulin delivery (AID) systems and discuss the implications of both approved and off-label options for the user and health-care providers. By pairing insulin pumps with CGM, AID systems facilitate automated adjustment in insulin delivery based on CGM readings. A subset of these have been developed commercially and were granted regulatory approval. In contrast, unregulated do-it-yourself AID systems, designed and set up by people living with type 1 diabetes and their families, have advanced rapidly and are gaining popularity worldwide. These patient-driven technologies have demonstrated impressive user self-reported improvements in glycemic control and quality of life, but have not been evaluated in any formal randomized controlled trials or by regulators. This presents challenging uncertainty for health-care providers, in addition to ethical and legal implications in supporting people with diabetes who wish to use these technologies. The current knowledge, opinions and practices relating to the use of AID systems across Canada are unknown. Gathering this information will highlight current practice and areas of knowledge gaps and concern and will assist in focussed education. This understanding is crucial to ensure people with type 1 diabetes using these systems have access to optimal, consistent and safe patient-centred care.
- Published
- 2022
39. Covid-19 threat and coping: application of protection motivation theory to the pandemic experiences of people affected by amyotrophic lateral sclerosis
- Author
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Shelagh K. Genuis, Westerly Luth, Tania Bubela, and Wendy S. Johnston
- Subjects
Motivation ,SARS-CoV-2 ,Adaptation, Psychological ,Amyotrophic Lateral Sclerosis ,COVID-19 ,Humans ,Neurology (clinical) ,General Medicine ,Pandemics - Abstract
Background People with amyotrophic lateral sclerosis (ALS) are at high risk for severe outcomes from Covid-19 infection. Researchers exploring ALS and Covid-19 have focused primarily on system response and adaptation. Using Protection Motivation Theory, we investigated how people with ALS and family caregivers appraised and responded to Covid-19 threat, the ‘costs’ associated with pandemic response, and how health professionals and systems can better support people affected by ALS who are facing public health emergencies. Methods Data were drawn from the ‘ALS Talk Project,’ an asynchronous, moderated focus group study. Participants were recruited from regions across Canada. Seven groups met online over 14 weeks between January and July 2020. Fifty-three participants contributed to Covid-19 discussions. Data were qualitatively analyzed using directed content analysis and the constant-comparative approach. Results Participants learned about the Covid-19 pandemic from the media. They rapidly assessed their vulnerability and responded to Covid-19 threat by following recommendations from health authorities, information monitoring, and preparing for worst-case scenarios. Adopting protective behaviors had substantial response costs, including adaptations for medical care and home support workers, threatened access to advance care, and increased caregiver burden. Participants expressed need for ALS-specific, pandemic information from trusted health professionals and/or ALS health charities. Telemedicine introduced both conveniences and costs. Prior experience with ALS provided tools for coping with Covid-19. Threat and coping appraisal was a dynamic process involving ongoing vigilance and adaptation. Findings draw attention to the lack of emergency preparedness among participants and within health systems. Conclusions Clinicians should engage ALS patients and families in ongoing discussions about pandemic coping, strategies to mitigate response costs, care pathways in the event of Covid-19 infection, and changing information about Covid-19 variants and vaccines. Healthcare systems should incorporate flexible approaches for medical care, leveraging the benefits of telemedicine and facilitating in-person interaction as needed and where possible. Research is needed to identify strategies to mitigate response costs and to further explore the interaction between prior experience and coping. Further study is also needed to determine how communication about emergency preparedness might be effectively incorporated into clinical care for those with ALS and other medically vulnerable populations.
- Published
- 2021
40. Monitoring progress toward United Nations commitments: characteristics of Canadian legislation to promote tobacco control, physical activity and healthy eating. A descriptive study
- Author
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Jennifer O’Loughlin, Tania Bubela, Kendall Tisdale, Christine Czoli, Kim D. Raine, Katerina Maximova, and John Minkley
- Subjects
business.industry ,Research ,Tobacco control ,Psychological intervention ,Subsidy ,Legislation ,Legislature ,General Medicine ,restrict ,Environmental health ,Medicine ,Descriptive research ,Enforcement ,business - Abstract
BACKGROUND: Legal interventions are important mechanisms for chronic disease prevention. Since Canadian laws to promote physical activity and healthy eating are growing, we compared the characteristics of legal interventions targeting physical activity and healthy eating with tobacco control laws, which have been extensively described. METHODS: We reviewed 718 federal, provincial and territorial laws promoting tobacco control, physical activity and healthy eating captured in the Prevention Policies Directory between spring 2010 and September 2017. We characterized the legislation with regard to its purpose, tools to accomplish the purpose, responsible authorities, target location, level of coerciveness and provisions for enforcement. RESULTS: Two-thirds (67.9%) of tobacco control legislation had a primary chronic disease prevention purpose (explicit in 5.3% of documents and implicit in 62.6%), and 29.5% had a secondary chronic disease prevention purpose. One-quarter (27.0%) of physical activity legislation had a primary chronic disease prevention purpose (explicit in 8.8% of documents and implicit in 18.1%), and 53.0% had a secondary chronic disease prevention purpose. In contrast, 69.3% of healthy eating legislation had no chronic disease prevention purpose. Tobacco control legislation was most coercive (restrict or eliminate choice), and physical activity and healthy eating legislation was least coercive (provide information or enable choice). Most tobacco control legislation (85.8%) included provisions for enforcement, whereas 47.4% and 24.8% of physical activity and healthy eating laws, respectively, included such provisions. Patterns in responsible authorities, target populations, settings and tools to accomplish its purpose (e.g., taxation, subsidies, advertising limits, prohibitions) also differed between legislation targeting tobacco control versus physical activity and healthy eating. INTERPRETATION: Legislative approaches to promote physical activity and healthy eating lag behind those for tobacco control. The results serve as a baseline for building consensus on the use of legislation to support approaches to chronic disease prevention to reduce the burden of chronic disease in Canadians.
- Published
- 2019
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41. Importance of Participant-Centricity and Trust for a Sustainable Medical Information Commons
- Author
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John Wilbanks, Juli Bollinger, Bartha Maria Knoppers, Robert Cook-Deegan, Patricia A. Deverka, Arti K. Rai, Michael S. Watson, Eric Boerwinkle, Barbara A. Koenig, Amy L. McGuire, Sharon F. Terry, Mary A. Majumder, Laura Lyman Rodriguez, Nanibaa’ A. Garrison, Jessica Bardill, Melissa M. Goldstein, John E. Mattison, Barbara J. Evans, Henry T. Greely, Tania Simoncelli, J. Mark Lambright, Adrian Thorogood, Scott Kahn, Christopher P. O'Donnell, Tania Bubela, David Glazer, and Angela G. Villanueva
- Subjects
0303 health sciences ,Knowledge management ,Information Dissemination ,business.industry ,Health Policy ,Community Participation ,Medical information ,General Medicine ,Trust ,Article ,03 medical and health sciences ,Issues, ethics and legal aspects ,0302 clinical medicine ,Trustworthiness ,Stakeholder Participation ,Humans ,Landscape analysis ,030212 general & internal medicine ,Sociology ,Commons ,business ,Medical Informatics ,030304 developmental biology - Abstract
Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons (MIC). We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
- Published
- 2019
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42. ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update
- Author
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Fuchou Tang, Insoo Hyun, Azim Surani, Julie Steffann, Ellen Wright Clayton, Lori R. Hill, Xiaomei Zhai, Jin-Soo Kim, Nicolas C. Rivron, Ali H. Brivanlou, Melissa K. Carpenter, Steve A. Goldman, Roger A. Pedersen, Jonathan Kimmelman, Mitinori Saitou, Jeff Round, Jürgen A. Knoblich, Misao Fujita, Hiromitsu Nakauchi, Kathy K. Niakan, Amander T. Clark, Gail Naughton, Luigi Naldini, Janet Rossant, R. Alta Charo, Debra J. H. Mathews, Roger A. Barker, Patricia J. Zettler, Tania Bubela, Kazuto Kato, Ubaka Ogbogu, Andy Greenfield, George Q. Daley, Leigh Turner, Megan Munsie, Eric Anthony, Heather M. Rooke, Nuria Montserrat, Yali Cong, Jeremy Sugarman, Jianping Fu, Douglas Sipp, Jeffrey P. Kahn, Jun Takahashi, Robin Lovell-Badge, Jack Mosher, Rosario Isasi, Barker, Roger [0000-0001-8843-7730], Niakan, Kathy [0000-0003-1646-4734], Surani, Azim [0000-0002-8640-4318], Apollo - University of Cambridge Repository, and Munsie, Megan [0000-0003-3588-8321]
- Subjects
Societies, Scientific ,0301 basic medicine ,Clinical Sciences ,Biology ,Regenerative Medicine ,Biochemistry ,Regenerative medicine ,03 medical and health sciences ,0302 clinical medicine ,Resource (project management) ,Stem Cell Research - Nonembryonic - Human ,Genetics ,Humans ,Bioethical Issues ,Stem Cells ,Scientific ,Cell Biology ,Stem Cell Research ,Policy ,030104 developmental biology ,Perspective ,Practice Guidelines as Topic ,Stem Cell Research - Nonembryonic - Non-Human ,Engineering ethics ,Generic health relevance ,Biochemistry and Cell Biology ,Stem cell ,Societies ,030217 neurology & neurosurgery ,Developmental Biology - Abstract
Summary The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here., The updated Guidelines for Stem Cell Research and Clinical Translation describe the ethical principles and best practices for basic, translational, and clinical research involving stem cells and human embryos. The updated Guidelines include new recommendations to address the recent scientific advances involving embryos, stem cell-based embryo models, chimeras, organoids, and genome editing.
- Published
- 2021
- Full Text
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43. Application of Protection Motivation Theory to Clinical Trial Enrolment for Pediatric Chronic Conditions
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Tania Bubela and Stephanie Brooks
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Male ,Parents ,medicine.medical_specialty ,Chronic condition ,Pediatric clinical trial ,Context (language use) ,Information needs ,Risk communication ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Gene therapy ,Informed consent ,medicine ,Humans ,030212 general & internal medicine ,Adverse effect ,Inherited retinal disease ,Child ,Type 1 diabetes ,Stem cell therapy ,Clinical Trials as Topic ,Motivation ,Protection motivation theory ,business.industry ,Patient Selection ,Diabetes ,lcsh:RJ1-570 ,lcsh:Pediatrics ,medicine.disease ,3. Good health ,Clinical trial ,chemistry ,030220 oncology & carcinogenesis ,Family medicine ,Pediatrics, Perinatology and Child Health ,Chronic Disease ,Female ,ATMP ,business ,Research Article - Abstract
Background Parents of children living with chronic but manageable conditions hope for improved therapies or cures, including Advanced Therapy Medicinal Products (ATMPs). Multiple pediatric clinical trials for ATMPs are underway, but the risk profile of ATMPs for chronic conditions is largely unknown and likely different than for terminal pediatric illnesses. Applying Protection Motivation Theory modified to the context of pediatric ATMP clinical trial enrollment, our study analyses information needs of parents of children living with chronic manageable conditions: Type 1 Diabetes (T1D) or Inherited Retinal Diseases (IRD). Methods We conducted semi-structured interviews with 15 parents of children living with T1D and 14 parents of children living with an IRD about: a) family background and the diagnostic experience; b) awareness of gene and stem cell therapy research and clinical trials for T1D and IRD; c) information sources on trials and responses to that information; d) attitudes to trial participation, including internationally; e) understanding of trial purpose and process; and f) any experiences with trial participation. We then discussed a pediatric ATMP clinical trial information sheet, which we developed with experts. We applied directed qualitative content analysis, based on PMT, to examine the information preferences of parents in deciding whether to enrol their children in stem cell or gene therapy clinical trials. Results Parents balanced trial risks against their child’s ability to cope with the chronic condition. The better the child’s ability to cope with vision impairment or insulin management, the less likely parents were to assume trial risks. Conversely, if the child struggled with his/her vision loss, parents were more likely to be interested in trial participation, but only if the risks were low and likelihood for potential benefit was high. Conclusions Fear of adverse events as part of threat appraisal was the predominant consideration for parents in considering whether to enroll their child living with a manageable, chronic condition in a pediatric clinical trial of an ATMP. This consideration outweighed potential benefits and severity of their child’s condition. Parents called for available safety data and fulsome communication processes that would enable them to make informed decisions about clinical trial enrolment on behalf of their children.
- Published
- 2020
44. Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges
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Lori Knowles, Westerly Luth, and Tania Bubela
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Knowledge management ,precision medicine ,‘omics’ ,Alternative medicine ,Medicine (miscellaneous) ,Intellectual property ,Biochemistry, Genetics and Molecular Biology (miscellaneous) ,03 medical and health sciences ,diagnostics ,medicine ,Information system ,Reimbursement ,device regulation ,business.industry ,biomarkers ,personalized medicine ,intellectual property ,Precision medicine ,reimbursement ,3. Good health ,030104 developmental biology ,Incentive ,Family medicine ,Original Article ,Personalized medicine ,drug regulation ,business ,Law ,Healthcare system - Abstract
Personalized medicine (PM) aims to harness a wave of ‘omics’ discoveries to facilitate research and discovery of targeted diagnostics and therapies and increase the efficiency of healthcare systems by predicting and treating individual predispositions to diseases or conditions. Despite significant investment, limited progress has been made bringing PM to market. We describe the major perceived regulatory, intellectual property, and reimbursement challenges to the development, translation, adoption, and implementation of PM products into clinical care. We conducted a scoping review to identify (i) primary challenges for the development and implementation of PM identified in the academic literature; (ii) solutions proposed in the academic literature to address these challenges; and (iii) gaps that exist in that literature. We identified regulatory barriers to PM development and recommendations in 344 academic papers. Regulatory uncertainty was a cross-cutting theme that appeared in conjunction with other themes including: reimbursement; clinical trial regulation; regulation of co-development; unclear evidentiary requirements; insufficient incentives for research and development; incompatible information systems; and different regulation of different diagnostics. To fully realize the benefits of PM for healthcare systems and patients, regulatory, intellectual property, and reimbursement challenges need to be addressed in lock step with scientific advances.
- Published
- 2017
- Full Text
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45. Opportunities and challenges for the cellular immunotherapy sector: a global landscape of clinical trials
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Tania Bubela, Katherine Bonter, Jean-Sébastien Delisle, Silvy Lachance, and Zackariah Breckenridge
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0301 basic medicine ,Clinical Trials as Topic ,Embryology ,business.industry ,Biomedical Engineering ,Translational research ,Business model ,Biotechnology ,Clinical trial ,03 medical and health sciences ,030104 developmental biology ,Neoplasms ,Humans ,Adoptive cellular therapy ,Medicine ,Immunotherapy ,Cellular immunotherapy ,Marketing ,business - Abstract
Global investments in cellular immunotherapies reflect their curative potential. Our landscape of clinical trials will aid developers, investors, adopters and payers in planning for adoption and implementation along realistic time horizons. Trend data enable stakeholders to adapt their business models and capacity to bring immunotherapies to the clinic. For cancer, trends suggest a shift from cancer vaccines to adoptive cellular transfer, alongside a focus on solid tumors. Academic centers, mainly in the USA, lead in early-phase clinical trials and target identification; but industry involvement has increased fourfold over the past two decades. Trends indicate an increasingly personalized approach to onco-immunology, which raises challenges for cost-effective manufacturing and delivery models. Overcoming these challenges provides opportunities for innovative biotechnology firms.
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- 2017
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- View/download PDF
46. Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic
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Christine Critchley, Satoshi Kodama, Margaret Otlowski, Merlin Crossley, Sheryl de Lacey, Erika Kleiderman, Joanne L. Dickinson, Jennifer K. Wagner, Jac Charlesworth, Tess Whitton, Dianne Nicol, Rebekah McWhirter, Lisa Eckstein, Joanne Kamens, Donald Chalmers, Michael Morrison, Kathryn P. Burdon, John Liddicoat, Jane Nielsen, David A. Mackey, Kazuto Kato, Ainsley J Newson, Sarah Chan, Alex W. Hewitt, Jacob S. Sherkow, Tania Bubela, Liddicoat, John [0000-0001-7370-3936], and Apollo - University of Cambridge Repository
- Subjects
0301 basic medicine ,lcsh:QH426-470 ,Somatic cell ,Genetic enhancement ,Systems biology ,Biomedical Technology ,Cell- and Tissue-Based Therapy ,lcsh:Medicine ,Biology ,Bioinformatics ,03 medical and health sciences ,0302 clinical medicine ,Genome editing ,Genetics ,CRISPR ,Effective treatment ,Humans ,Clustered Regularly Interspaced Short Palindromic Repeats ,Molecular Biology ,Genetics (clinical) ,Comment ,lcsh:R ,Ethics committee ,Human genetics ,Intellectual Property ,lcsh:Genetics ,030104 developmental biology ,Molecular Medicine ,Clinical Medicine ,030217 neurology & neurosurgery - Abstract
Editorial summary Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.
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- 2019
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47. Participant perspectives on a phase I/II ocular gene therapy trial (NCT02077361)
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Tania Bubela, Shelly Benjaminy, and Stephanie Brooks
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0301 basic medicine ,medicine.medical_specialty ,Biomedical Research ,Patients ,Genetic enhancement ,030105 genetics & heredity ,03 medical and health sciences ,0302 clinical medicine ,Clinical Trials, Phase II as Topic ,Informed consent ,medicine ,Humans ,Genetics (clinical) ,Clinical Trials, Phase I as Topic ,business.industry ,Genetic Therapy ,3. Good health ,Clinical trial ,Ophthalmology ,Phase i ii ,Pediatrics, Perinatology and Child Health ,030221 ophthalmology & optometry ,Physical therapy ,Perception ,Patient Participation ,business ,Choroideremia - Abstract
Background: To learn from the experiences of potential clinical trial participants, participants in a Phase 1 ocular gene therapy trial, and their partners to improve communications and tri...
- Published
- 2019
48. Medical Information Commons to Support Learning Healthcare Systems: Examples From Canada
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Lawrence W. Svenson, Nicole Mittmann, Katerina Podolak, Naveed Z. Janjua, Tania Bubela, Shelagh K. Genuis, and Mel Krajden
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0301 basic medicine ,Canada ,business.industry ,Information Dissemination ,Health Policy ,Medical information ,General Medicine ,Public relations ,Learning Health System ,Disadvantaged ,03 medical and health sciences ,Issues, ethics and legal aspects ,030104 developmental biology ,0302 clinical medicine ,Health care ,Humans ,030212 general & internal medicine ,Health information ,business ,Commons ,Medical Informatics ,Healthcare system - Abstract
We explore how principles predicting the success of a medical information commons (MIC) advantaged or disadvantaged three MIC initiatives in three Canadian provinces. Our MIC case examples demonstrate that practices and policies to promote access to and use of health information can help improve individual healthcare and inform a learning health system. MICs were constrained by heterogenous health information protection laws across jurisdictions and risk-averse institutional cultures. A networked approach to MICs would unlock even more potential for national and international data collaborations to improve health and healthcare.
- Published
- 2019
49. Automated content analysis as a tool for research and practice: a case illustration from the Prairie Creek and Nico environmental assessments in the Northwest Territories, Canada
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David S. Hik, Tania Bubela, and Jennifer Ann McGetrick
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business.industry ,Process (engineering) ,05 social sciences ,Geography, Planning and Development ,0211 other engineering and technologies ,021107 urban & regional planning ,02 engineering and technology ,Management, Monitoring, Policy and Law ,Public relations ,computer.software_genre ,0506 political science ,Scripting language ,Content analysis ,Public participation ,Political science ,Sustainability ,050602 political science & public administration ,Environmental impact assessment ,Public engagement ,business ,computer ,Environmental planning ,Barriers to entry - Abstract
Public engagement is essential to the procedural and substantive sustainability of environmental assessment. Public hearings present the lowest barrier to entry for public participation, but these forums face competing political pressures for conducting appropriate public engagement within an expeditious process. Repositories of public hearing testimony provide a source of primary data for examining these public engagement issues during environmental assessments. However, the time and resources required may be prohibitive for conducting the kind of in-depth qualitative analyses that are commonly used. Automated content analysis (ACA) techniques can provide a rapid, replicable, inductive, and systematic way to examine public hearing transcripts, consisting of the critical development and application of computer programming scripts that synthesize evidence from extensive document sets. This case illustration demonstrates the potential utility of ACA, based on the examination of two public hearings, ...
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- 2016
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50. DNA barcoding in the media: does coverage of cool science reflect its social context?
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Emma Camicioli, Tania Bubela, and Janis Geary
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0301 basic medicine ,Science ,Corporate governance ,05 social sciences ,Newspapers as Topic ,Social environment ,050801 communication & media studies ,Context (language use) ,Media coverage ,General Medicine ,Biology ,DNA barcoding ,Data science ,Newspaper ,03 medical and health sciences ,030104 developmental biology ,0508 media and communications ,Genetic resources ,Genetics ,DNA Barcoding, Taxonomic ,Humans ,Social Media ,Molecular Biology ,Biotechnology - Abstract
Paul Hebert and colleagues first described DNA barcoding in 2003, which led to international efforts to promote and coordinate its use. Since its inception, DNA barcoding has generated considerable media coverage. We analysed whether this coverage reflected both the scientific and social mandates of international barcoding organizations. We searched newspaper databases to identify 900 English-language articles from 2003 to 2013. Coverage of the science of DNA barcoding was highly positive but lacked context for key topics. Coverage omissions pose challenges for public understanding of the science and applications of DNA barcoding; these included coverage of governance structures and issues related to the sharing of genetic resources across national borders. Our analysis provided insight into how barcoding communication efforts have translated into media coverage; more targeted communication efforts may focus media attention on previously omitted, but important topics. Our analysis is timely as the DNA barcoding community works to establish the International Society for the Barcode of Life.
- Published
- 2016
- Full Text
- View/download PDF
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