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Background: Most studies do not produce their intended outcomes on time or within budget. However, it is challenging to identify the facilitators and barriers to successful study management when the "behind the scenes action" of especially digitally enabled health research studies are akin to a black box. Therefore, it is necessary to explore first-hand experience of the facilitators and barriers to managing digitally enabled health studies. The goal of such studies is to produce new knowledge and/or develop tools that can be translated to real-world benefits for the health and care sector, individuals, and other stakeholders. These studies now exist in a time that encourages collaborative research activities with interdisciplinary research partnerships, industry collaboration, end-user involvement and insights for policy. These expectations require teams with different work cultures, methodologies, technologies, and approaches to work together, resulting in significant benefits but also challenges. Objectives: To explore the relationship between the dynamics and needs of research teams and the technology used to manage digitally enabled studies through the experience of those who worked on such studies. Methods: We used an interpretive phenomenological approach to explore research team members' experiences and perceptions of study management in the field of digitally enabled health research. We interviewed 15 research team members from eight studies. A semi-structured interview guide was used to explore concepts related to study activity management, team dynamics, resources and technologies used to manage research activities, and reflections of personal experiences. An adductive thematic analysis was performed on the transcripts. Results: Five main themes were identified: 1) Project Team, 2) Study management, which included management technologies, 3) Study plan, 4) Intervention, 5) Participants. This paper focuses on the first two main themes. Sub-themes included: Roles and responsibilities, Methods, Changes, Challenges and solutions and Expectations vs. reality. Sub-themes were applicable to all main themes. Therefore, results were presented as knowledge gained from the interaction between sub-themes within each theme, i.e. referred to as "comprehensive insights" in the results section of this paper. Conclusion: This interview study provides new knowledge about the realities of working in collaborative, digitally enabled health research studies and demonstrates several opportunities for improved understanding of study management. More realistic and thorough understanding of the complex system in which digitally enabled health research exists can be applied to better prepare experienced researchers and newly graduated students entering the field, as well as improve existing strategies for management. Highlights: 1. Research team members with developed skills from other fields can add value to research projects by contributing relevant yet different perspectives and solutions, regardless of a lack of experience in digitally enabled health studies. 2. Working together while having different approaches to science, e.g. building knowledge subjectively via experience (constructivism) vs. gaining knowledge objectively via observation and structured study (positivism), requires us all to understand the purpose of each approach and openly acknowledge one another's contributions. 3. Researchers are eternal learners – given the speed of technology development and work cultures of collaborating non-scientific research-based partners, we need to expand our knowledge of methodologies and research approaches to keep pace and relevance. 4. The use of study management technologies was largely unplanned. Research team members chose and used systems and programs that they were familiar with and available at the time. 5. The multitude of study management technologies mentioned were individually focused on a study stage or task, largely siloed, and subsequently challenging for collaborative tasks. [ABSTRACT FROM AUTHOR]

Abstract Background Most studies do not produce their intended outcomes on time or within budget. However, it is challenging to identify the facilitators and barriers to successful study management when the “behind the scenes action” of especially digitally enabled health research studies are akin to a black box. Therefore, it is necessary to explore first-hand experience of the facilitators and barriers to managing digitally enabled health studies. The goal of such studies is to produce new knowledge and/or develop tools that can be translated to real-world benefits for the health and care sector, individuals, and other stakeholders. These studies now exist in a time that encourages collaborative research activities with interdisciplinary research partnerships, industry collaboration, end-user involvement and insights for policy. These expectations require teams with different work cultures, methodologies, technologies, and approaches to work together, resulting in significant benefits but also challenges. Objectives To explore the relationship between the dynamics and needs of research teams and the technology used to manage digitally enabled studies through the experience of those who worked on such studies. Methods We used an interpretive phenomenological approach to explore research team members’ experiences and perceptions of study management in the field of digitally enabled health research. We interviewed 15 research team members from eight studies. A semi-structured interview guide was used to explore concepts related to study activity management, team dynamics, resources and technologies used to manage research activities, and reflections of personal experiences. An adductive thematic analysis was performed on the transcripts. Results Five main themes were identified: 1) Project Team, 2) Study management, which included management technologies, 3) Study plan, 4) Intervention, 5) Participants. This paper focuses on the first two main themes. Sub-themes included: Roles and responsibilities, Methods, Changes, Challenges and solutions and Expectations vs. reality. Sub-themes were applicable to all main themes. Therefore, results were presented as knowledge gained from the interaction between sub-themes within each theme, i.e. referred to as “comprehensive insights” in the results section of this paper. Conclusion This interview study provides new knowledge about the realities of working in collaborative, digitally enabled health research studies and demonstrates several opportunities for improved understanding of study management. More realistic and thorough understanding of the complex system in which digitally enabled health research exists can be applied to better prepare experienced researchers and newly graduated students entering the field, as well as improve existing strategies for management.

Background: The growth of patient and public involvement in clinical research highlights the paucity of literature on operational practices that ensure the success of large, patient-centered outcomes trials. The authors' objective was to identify tools launched by the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study team to determine their effectiveness in maximizing patient enrollment in this observational, pragmatic trial., Methods: The primary outcomes for this study were patient screening and enrollment across 36 CISTO study sites. The operational strategies included CISTOquestion email correspondence and All Sites Meetings, specifically poll performance data from meetings, and a nonanonymized feedback survey about the CISTO study's management practices. Effectiveness was measured using correlation analysis with patient cohort data, including screenings, enrollments, post-hoc exclusions, and the post-hoc exclusion rate., Results: Average screenings and enrollment rose after the implementation of CISTOquestion in April 2021, with the average number of screenings rising from 7.42 to 26.8 patients per month and enrollment rising from 3.76 to 16 patients per month. Use of CISTOquestion was correlated strongly with increased patient screenings and enrollment across all study sites. Eighty-three percent of sites with above-average post-hoc exclusion rates (≥0.092) sent below the average number of CISTOquestion inquiries. Poll performance and survey data revealed that all survey respondents who used CISTOquestion found that it was a valuable and accessible resource., Conclusions: Of the several operational tools implemented within the CISTO study that aimed to improve patient enrollment, CISTOquestion, a centralized email for addressing eligibility questions, was most beneficial to overall patient accrual., (© 2024 American Cancer Society.)

The National Drug Abuse Treatment Clinical Trials Network (CTN) was initiated by the National Institute on Drug Abuse (NIDA) in 2000 with the aim of improving substance use treatment and reducing the time between the discovery of effective treatments and their implementation into clinical practice. While initial trials were conducted almost exclusively in specialty addiction treatment settings, the CTN began evolving strategically in 2010 to conduct research in general medical settings, including healthcare systems, primary care settings, emergency departments, and pharmacies, to broaden impact. The advantages of a research network like the CTN is not only the collective content expertise that investigators contribute to the network, but the collective experience gained by conducting studies in the network and then applying those lessons to future studies. To summarize trial implementation challenges encountered, and the process by which solutions were identified and implemented, within one of the last early-phase CTN Stage II behavioral intervention studies conducted in a specialty addiction treatment setting. We describe the implementation of the CTN-0037 STimulant Reduction Intervention using Dosed Exercise (STRIDE) trial. Issues encountered during study implementation are categorized into four major areas, described in terms useful to future study teams: 1) study team infrastructure challenges, 2) participant- and site- level challenges, 3) intervention-related challenges, and 4) longitudinal study design challenges. Potential consequences of identified problems and the solutions developed to manage these problems are discussed within the context of these four areas. We propose how to extend these implementation lessons and apply them in other healthcare settings to expand the CTN. Effective study management allows for flexible, collaborative solutions to expected and unexpected obstacles to study success. Implementation strategies derived from the first 15 to 20 years of CTN studies are a result of working with providers and participants, and the ongoing collaboration among CTN investigators and network staff. Timely identification and response to problems during study implementation are critical to the success of a trial, regardless of its design. We believe a collaborative approach to identifying and responding to study implementation challenges will increase the likelihood of successful adoption of relevant, efficacious interventions. As the CTN continues to expand, the wealth of successful trial implementation strategies developed during the first 20 years of the CTN need to be applied and adapted to studies in broader network settings, and considered in conjunction with more formalized implementation science processes that are currently available. • Effective trial management requires • collaborative and ongoing problem-solving • CTN trials have expanded from specialty settings to larger general medical settings • Historical implementation lessons from earlier CTN trials can meaningfully inform future trials • We describe CTN0037's infrastructure, participant- and site- level, intervention, and longitudinal design challenges • Historical information coupled with structured monitoring can increase trial impact [ABSTRACT FROM AUTHOR]

Blended Learning combines the advantages of online learning and conventional classroom. However, merely combining online learning and conventional classroom might not fulfill students’ need, and could lead to unexpected failure. Therefore, it is necessary to know the students’ readiness, which is a prerequisite for the successful implementation of this learning model. This is a qualitative and quantitative descriptive research, aims to describe the students’ readiness for Blended Learning implementation, viewed from the students’ attitude towards learning aspects in Blended Learning. The questionnaires were distributed to 108 students of the Faculty of Information and Technology to know the use of technology, internet access, online activities, and the students’ attitude toward learning aspects. In-depth interviews to the students were conducted to know deeper on the students’ attitude toward the learning aspects in BL. The findings show that the students were very ready for the implementation of Blended Learning. It can be seen from students’ positive atitude toward online aspects (learning flexibility, online learning, online interaction, and study management), as much as 83%, higher that the score of their attitude toward conventional classroom learning which is 77%. The students’readiness is a foundation for the successful implementation of Blended Learning, which should be supported by both lecturers and organization.

From the perspective of study management, research is surprisingly lacking on two of the major challenges for planning and performing content analysis: determining the sample size (i.e. number of objects to code) and the required number of coders to hire. The optimization of both of these numbers will ultimately determine how efficiently available resources are used. This study contributes to the methodological discussion on coding by identifying and conceptualizing the role of learning effects with respect to the coding task and by highlighting the importance of considering the coding process when managing a content analysis. We present empirical evidence for the existence and impact of learning effects on coders' coding speed. Accordingly, study management should take account of learning effects when determining the sample size and number of coders. We also provide an illustrative example of how learning effects can impact the results of pretests. [ABSTRACT FROM AUTHOR]

Conditional power combines the findings of a partially completed study with assumptions about the future. The goal is to estimate the probability that the eventual study result will be incompatible with a criterion value, such as acceptable risk or the null hypothesis. Some history and motivation for conditional power calculations are provided, with examples illustrating the application to drug safety studies. This is an expository article suggesting that conditional power, which is well-established in clinical trials research, also has application to observational studies. The utility may be highest in regulatory settings where resources are limited and interim decisions have to be made accurately in the shortest possible time. [ABSTRACT FROM AUTHOR]

Over the past two decades, the involvement of a Pharmacist Scientist in clinical settings has improved patient safety, decreased medication errors, and enabled successful conduct of clinical trials and faster product development [1–5]. The impact of an oversight by a Pharmacist Scientist on clinical trial performance and execution in terms of Pharmacy and Investigational Product (IP)-related deviations has not been evaluated by a sponsor. This was a retrospective observational study conducted by the Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID). We assessed the association of the number of Pharmacy and Investigational Product (IP)-related deviations with Pharmacist oversight and use of DAIT Pharmacy/ Pharmaceutical services in two groups: Intervention Group (IG) and the Control Group (CG). We evaluated monitoring data from 116 studies conducted between 2006 through 2020. Forty-one eligible clinical trials were included and analyzed: 13 trials were in the IG with Pharmacist oversight and use of Pharmacy Services; 28 trials were in the CG with no Pharmacist oversight and zero to partial use DAIT Pharmacy/ Pharmaceutical Services. The evaluation revealed the expected risk of having a pharmacy and IP-related deviations were 2.94 times higher (95% CI 1.28, 6.67, = 0.01) in trials not having Pharmacist oversight and zero to partial use of Pharmaceutical/ Pharmacy Program services. This significant finding was associated with having Pharmacist oversight when adjusting for study size (# of sites and patients needed), anticipated study duration, design complexity, and whether recruitment was completed or not. We found a statistically significant association between Pharmacist Scientist involvement and oversight from protocol development to study execution and a reduction in Pharmacy and IP-related deviations. [ABSTRACT FROM AUTHOR]

Hybrid effectiveness-implementation studies allow researchers to combine study of a clinical intervention's effectiveness with study of its implementation with the aim of accelerating the translation of evidence into practice. However, there currently exists limited guidance on how to design and manage such hybrid studies. This is particularly true for studies that include a comparison/control arm that, by design, receives less implementation support than the intervention arm. Lack of such guidance can present a challenge for researchers both in setting up but also in effectively managing participating sites in such trials. This paper uses a narrative review of the literature (Phase 1 of the research) and comparative case study of three studies (Phase 2 of the research) to identify common themes related to study design and management. Based on these, we comment and reflect on: (1) the balance that needs to be struck between fidelity to the study design and tailoring to emerging requests from participating sites as part of the research process, and (2) the modifications to the implementation strategies being evaluated. Hybrid trial teams should carefully consider the impact of design selection, trial management decisions, and any modifications to implementation processes and/or support on the delivery of a controlled evaluation. The rationale for these choices should be systematically reported to fill the gap in the literature., Competing Interests: NS is the director of the London Safety and Training Solutions Ltd, which offers training in patient safety, implementation solutions and human factors to healthcare organisations and the pharmaceutical industry. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer JM declared a shared affiliation, with no collaboration, with one of the authors, NS, to the handling editor at the time of the review., (© 2023 Jurczuk, Thakar, Carroll, Phillips, Meulen, Gurol-Urganci and Sevdalis.)

Background: The aim of this article was to describe and discuss several strategies and standard operating procedures undertaken in the EpiReumaPt study--which was the first Portuguese, national, cross-sectional population-based study of Rheumatic and Musculoskeletal Diseases (RMD). Methods: The technical procedures, legal issues, management and practical questions were studied, analyzed and discussed with relevant stakeholders. During the 1st phase of EpiReumaPt the coordination team and Centro de Estudos de Sondagens e Opinião (CESOP) worked to recruit and interview 10,661 subjects. The 2nd phase involved the participation of a multidisciplinary team, several local authorities, a specialized vehicle ("mobile unit") and a specific software program for the clinical appointments. The development of specific recruitment strategies improved the participation rate. Blood samples were collected and sent to Biobanco-IMM and to a central lab for immediate measurements. In the 3rd phase the RMD diagnosis were validated by a team of three experienced rheumatologists-clinical data, imaging and lab test results were revised according to previously published classification criteria. Conclusion: EpiReumaPt was a nationwide project successfully conducted, which followed critical logistic/coordination and research strategies. EpiReumaPt methodology and coordination could be used as an example for other epidemiologic endeavors and public health policies. Keywords: Epidemiologic studies; Population-based study; Rheumatic Diseases; Epidemiology; Cross-sectional study; Study management [ABSTRACT FROM AUTHOR]

The Prostate Cancer Prevention Trial is a randomized double blind chemoprevention trial of 18,882 men. It is designed to test the difference in the histologically proven prostate cancer prevalence between a group of participants given finasteride and another given placebo for 7 years. We present an overview of the study design, details of the administrative structure of the study and a description of the successful implementation of the accrual phase. [Copyright &y& Elsevier]

We present a discussion of some of the lessons the investigators learned during the development and implementation phases of the Parents Matter! Program (PMP). Lessons were learned that are relevant to various groups involved in large scale, multi-site, community-based intervention studies: investigators, community leaders, community members, project staff, and participants. Specific lessons learned include: (1) forge collaboration early: (2) maintain communication; (3) clearly delineate policies and procedures; and (4) develop proactive strategies. We also include a list of important questions to consider when contemplating similar projects. [ABSTRACT FROM AUTHOR]