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The article focuses on the clinical research protocols become more complex, the patient's complete understanding of a study is paramount. It mentions that the Crofoot Research Center, a Houston-based practice that has run over 200 clinical studies in rare disease, is one site realizing the benefits of using patient-centric, sitefirst solutions.

In the article, the authors discuss the evolution of clinical trials from the use of papyrus to technology-driven data collection solutions. Other topics include the need to ensure data quality and integrity (DQI), the need for the pharmaceutical industry and regulators to refrain from using paper-based processes as gold standards, and the claim that the first clinical trial was conducted by King Nebuchadnezzar of Babylon as recorded in the Bible book of Daniel.

The article evaluates the use of backup solutions for electronic patient-reported outcome (ePRO) system. Topics discussed include that the web-based backup is often proposed as a practical solution which is better that paper work, it examines the effectiveness, usability and challenges with web-based electronic clinical outcome assessment (eCOA) backups and discussed on ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available) principles.

The article discusses the Critical Path Institute's Electronic Clinical Outcome Assessment (eCOA) Consortium survey results. It mentions that the survey investigates the use of backup solutions for electronic patient-report outcomes (ePRO) systems, it is evaluated using general approach to backup solution, the paper backup is used to support site-based ePRO collection and the respondents agreed that data captured via backup methods should be identified as such in the dataset.

The article discusses the concept of electronic consent (eConsent) in clinical trials and the need to bring it back on track. It highlights the various interpretations and misconceptions surrounding eConsent, emphasizing the importance of considering the specific needs of each study. It also introduces the efforts of the European Forum for Good Clinical Practice (EFGCP) eConsent initiative in harmonizing processes and providing practical guidelines for implementing eConsent effectively.

The article focuses on the evolution and impact of the concept "Clinical Research as a Care Option" (CRAACO), which was co-developed by the author and Jennifer Byrne to highlight the value of clinical trials in advancing patient care. Topics include the historical context of CRAACO, the positive results from a survey comparing patient satisfaction with clinical research-related care, and the ongoing efforts to enhance public awareness and accessibility of clinical trials.

An interview with Rust Felix, Chief Executive Officer of Slope, is presented who highlights challenges in Artificial Intelligence integration within clinical trials, focusing on data quality issues and compliance hurdles. Topics include improving data collection for AI training, streamlining database builds, data reconciliation, and enhancing data analytics for efficient clinical trial management.

The article offers suggestions for meeting regulatory concerns regarding Electronic Data Capture (EDC) data integrity and site control over the source of data in clinical trials. Topics include the consensus across the pharmaceutical industry regarding the maintenance of clinical data by writing results on papers; the guidelines of the U.S. Food and Drug Administration regarding use of electronic data in clinical trials; and guidelines of European Medicines Agency regarding electronic data.

The article focuses on the challenges and perspectives of clinical trial sites and clinical research associates (CRAs) regarding electronic clinical outcome assessment (eCOA) data collection in clinical trials. It addresses the need for simplification and flexibility in eCOA systems to reduce burden and improve usability, highlighting key findings related to site readiness and training, participant experience and compliance, and eCOA technology.

The article focuses on the use of electronic clinical outcome assessment (eCOA) to improve patient engagement in clinical trials. It discusses how the use of eCOA improves communication between patients and clinical staff, reporting of events, and implementation of training and patient engagement. Topics include the improved data quality with digital systems, importance of collecting clinical trial data via eCOA, and access to electronic medical record (EMR) data.

The article offers the author's insights on the importance of the electronic informed consent, which is a key to support patient-centric mantra in clinical trials. Topics discussed include the guidance on informed consent published by the U.S. Food and Drug Administration (FDA), various recommendations to obtain patient agreement which include clinical trials description, treatment benefits, and confidentiality, and the significance of language on patient's understanding on informed consent.

The article presents an interview with Sanjay Shukla, Chief executive officer of aTyr Pharma, about the company's clinical operations and ongoing Phase III study for pulmonary sarcoidosis. He discusses the challenges of conducting a large trial for a rare disease and how aTyr Pharma is overcoming them. He highlights the importance of incorporating patient feedback into the trial design and the significant role it plays in competitiveness and commercialization success.

The article discusses the importance of sustainability in clinical trials and how purposeful digitalization can contribute to more sustainable practices. The integration of advanced technologies in clinical trials, such as remote data monitoring and digitalization of site and patient experiences, can reduce environmental impact and conserve resources. Additionally, supply chain optimization and adherence to industry standards are crucial for reducing waste and improving sustainability. The article suggests that further exploration of AI and automation in clinical trials may enhance sustainability without compromising data quality and patient safety. The industry is committed to evaluating sustainable best practices and sharing knowledge to refine trial practices for the better. [Extracted from the article]

The article delves into the intricacies of oncology trials, highlighting their unique challenges such as patient diversity, complex inclusion criteria, and the need for adaptive trial designs. Topics include the complexity of cancer studies, recruitment difficulties, and calls for streamlined processes to improve patient access to innovative therapies.

The article focuses on the electronic implementation and migration of patient-reported outcome measures (ePROs) and presents a comprehensive guide developed by the eCOA Consortium. It covers the consolidation of best practices for ePRO implementation, emphasizing the importance of aligning with regulatory guidance, optimizing usability, and ensuring standardized approaches for implementing ePROs in clinical trials.

The article highlights the challenges of obtaining informed consent from intensive care unit (ICU) patients for clinical trials. It emphasizes the need for electronic consent (eConsent) platforms that can provide a flexible consenting process, particularly in time-sensitive acute care situations. It mentions that the adoption of eConsent can enhance patient recruitment, improve understanding of trial information, and simplify the consent process in challenging healthcare environments.

The article discusses a research survey which revealed the myths, challenges, and potential useful strategies related to bring your own device (BYOD) for electronic clinical trial outcome assessment (eCOA). Topics include the survey respondents, the attitudes of the respondents toward equivalence requirements, and the concern over perceived BYOD practical or technical issues or challenges.

The article offers information on the impact of Covid-19 pandemic on clinical trials in the U.S. It mentions that how healthcare industry found ways to keep trials going and came together to accelerate trial execution amid the pandemic. It discusses the identification of the right tools and systems to streamline problem areas, plan for change management.

The article focuses on the growing complexity of data collection in clinical trials, particularly in oncology, due to duplication between research systems and electronic health records (EHRs). Topics include the significant time and costs associated with data duplication, the explosion of data points in oncology trials driven by genomic and digital health advancements, and the need for innovative solutions and collaboration to manage data efficiently and reduce costs.

The article focuses on the evolving landscape of decentralized clinical trials (DCTs) as they shift from their initial surge of promise to a more tempered reality. Topics include the projected growth and current volatility of the DCT market, challenges in adoption and implementation faced by sites and sponsors, and perspectives from industry leaders on the future and impact of DCTs in clinical research.

The article focuses on the QUIET INTERNATIONAL REVOLUTION IN CLINICAL TRIAL REGULATION. Topics discussed include the work is going on within ICH—the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use; and the definition of essential documents may need updating since trials have moved on from a paper world with some rudimentary patient medical records and paper case record forms.

The article discusses the creation of a new eConsent platform that simplifies the clinical trial procedure for patients while also providing an acceptable solution for clinical trial sponsors. It analyzes the difficulties of implementing eConsent during a pandemic. It highlights the patient-centric eConsent platform's capabilities, the necessity for secure and practical clinical trial sponsors, and incorporates eConsent into the overall process.

The article offers information on the ensuring women to achieve the success in research among the COVID-19 pandemic related barriers. It further discusses successfully prevent more women from leaving the biomedical workforce altogether; decrease in submissions of scholarly papers authored by women to the medical journals during the pandemic; and opportunities for women to hire additional staff as a way to share the workload.

The article focuses on the potential benefits of standardizing data acquisition and submission processes in clinical trials, specifically in the context of electronic patient-reported outcome (ePRO) systems. It highlights the need to align CDISC standards throughout the ePRO data continuum and emphasizes the importance of involving key stakeholders in the early stages of ePRO system development to ensure regulatory compliance and improve data quality.

The article focuses on implementing new strategies with the use of patient-reported outcomes. Topics include the traditional endpoints in order to get a more complete and accurate picture of treatment benefit for patients, the expectation that indicators of clinical benefit beyond survival and tumor responses, such as a patient's quality of life and disease symptoms, and the most effectively evaluated through the use of patient-reported outcome measures.

The article focuses on selecting the clinical technology partner based on three criteria: Winning more business through dedicated support, innovating with adaptable technology solutions, and outperforming competition by enhancing expertise. It discusses how evaluating potential providers for collaborative relationships based on their abilities to win bids, offer innovative technology, and support operational excellence is crucial in navigating the dynamic landscape of drug development.

The article reports on regulatory considerations for a paperless clinical trial. Topics discussed include reason the pharmaceutical industry has been risk-averse in adopting modern-day technology tools that could support clinical trials, examples of regulated clinical trial software being used which include electronic data capture systems and electronic informed consent, and critical questions to be asked concerning the intended use of the software.

The article highlights the burgeoning investment in cancer drugs, poised to hit 375 billion U.S. dollars by 2027, underlining the pressing need for innovative therapies to enhance patient outcomes. Topics include the emergence of radioligand therapeutics, the intricacies of their development, and leveraging real-world data analytics to optimize trial design and patient care pathways.

The article presents several tips to help research sites implement decentralized clinical trials, along with mentions that decentralized clinical trials (DCTs) have boosted clinical transformation while the covid-19 pandemic has fueled their rapid expansion. It discusses that challenges to improve outcomes and experience for all stakeholders regarding the DCTs.

The article informs about managing clinical development programs that evaluate the efficacy, safety, and tolerability of new therapies requires close internal collaboration, including regulatory operations. Topics discussed include broad product portfolio across a global network can be inefficient if a patchwork of systems is used; and the slowly evolving shift from paper to cloud based regulatory information management systems (RIMS) to address regulatory operations challenges.

The article discusses the headlines in clinical development tout the potential of decentralized trials, with some even going to predict that trials will bypass sites through a combination of centralized clinical resources. It discusses the extensive involvement in decentralized clinical trials (DCTs) with the trial leverages a single site or a network of coordinated sites supported by wearable devices and platform solutions.

Applied Clinical Trials • April 2021 7 appliedclinicaltrialsonline.com EU REPORT Peter O'Donnell Brussels Correspondent EUROPE'S ETERNAL STRUGGLE WITH SAFETY AND INNOVATION Precaution continues to dominate EU thinking on science and technology-with politics intervening to offer some intriguing impacts on human health. According to a joint concept paper from ICPerMed and ERA PerMed (yet another EU initiative in the field), the new partnership "will be a prime driver for developing and implementing personalized medicine." The disarray among national governments in Europe will have done nothing to inspire confidence either in science in general, or in Europe's regulatory institutions-and least of all, confidence in vaccines. [Extracted from the article]

The article reports that While the COVID-19 pandemic has undoubtedly catalyzed the adoption of more flexible datacollection approaches within clinical trials, this has been the direction of travel for some time. Rather than bringing participants into sites, allowing them to participate from the safety of their own homes by leveraging remote datacollection methods placed participant preference at the center of the research effort and positively impacted participant engagement.

The article discusses the increasing demand for clinical data management (CDM) roles and the digitalization of clinical research; it reports the change from CDM to clinical data science (CDS). It highlights the new era of clinical research created by decentralized trials, wearable devices, and artificial intelligence. It discusses the effects of organizations struggling to find data scientists with the necessary skills, leading to a competitive job market.

The article discusses the study between risk-based monitoring (RBM) and remote trial management method with traditional on-site source data verification (SDV) for trial oversight. Topics include risk assessment service conducted to evaluate the high-risk data and processes; and RBM approach that identified critical errors in trial data and study conduct trends, within and across sites, more effectively when compared with on-site SDV.

The article focuses on pharmaceutical research industry has seen a recent explosion of publications and conferences has focused on decentralized and digital clinical trials. Topics include the terms "decentralized versus digital clinical trials," the results will overwhelmingly relate to decentralized clinical studies, and the decentralized and digital clinical trials are two different things.

The article discusses that the people are connected 24x7 via smartphones and apps, it is striking that up to half of clinical studies are still using paper to capture patient-reported outcomes. It mentions that the electronic clinical outcome assessment (eCOA) solutions have been around for decades and are of increasing importance as the COVID-19 pandemic has forced many sponsors to delay their clinical trials or implement virtual models.

The article discusses that the investigator-facing SaaS platform provides shared benefits for sites and sponsors. It mentions that this paper explores the benefits of a system that connects clinical researchers across sites and sponsors via a single-sign-on clinical trials technology, one that harmonizes key workflows across sponsors, and includes tools to remove redundancy and increase efficiency.

The article informs about the role of clinical data manager (CDM) for the clinical research ecosystem's future. Topics discussed include CDMs have changed as the industry shifts toward more complex protocols and elaborate data-collection requirements; and educational initiatives to serve as a roadmap for the future of the CDM's role within the clinical research ecosystem.

The article focuses on the challenges and evolving strategies for decentralized clinical trials (DCTs) in the post-COVID era, highlighting insights from Joachim Lövin. Topics include addressing regulatory difficulties and stakeholder hesitations, the importance of change management and adapting to new guidelines, and the role of industry organizations in providing tools and frameworks for implementing DCT elements effectively.

The article reports that U.S. Food & Drug Administration (FDA) investigators found inadequate drug accountability records in about 15% of sites audited in the U.S. and 20% in Europe. It notes that all trials can benefit from using IRT for electronic drug accountability management because it is designed with safeguards that reduce the risk of human error. It adds that the availability of centralized trial information provided by an IRT system is invaluable for this and other tasks.

The article offers the author's view on myths related to electronic informed consent (eConsent). These involve the lack of its adoption, most nations do not support it and high cost. He also notes the study from clinical research solutions provider WIRB Copernicus Group Inc. indicating its application by most pharmaceutical companies.

The article discusses the challenges and harmonization efforts related to data collection in the evolving landscape of electronic clinical outcome assessment (eCOA), electronic patient-reported outcome (ePRO), and digital health technology (DHT) within drug development. Topics include the distinct perspectives on ePROs/eCOAs and DHTs, the need for aligned terminology, and discussions among industry professionals on the impact, regulations, and future directions in this space.

The article discusses the importance of establishing a common terminology and lexicon for electronic clinical outcome assessments (eCOA) in order to minimize confusion and improve communication in technology-supported clinical research. It mentions that the eCOA Lexicon, developed through the eCOA: Getting Better Together Initiative (GBTI), provides a consensus-based source of definitions for eCOA-related terms, ensuring consistency and facilitating conversations in this evolving field.

The article reports that clinical research products and services firm CenterWatch, collaborated with Complion company, conducted a study to analyze the financial and resource burden faced during clinical trials. It states that the study concluded that sufficient infrastructure, and resources are being invested to live up to the government policies and regulations governing clinical trials and medical research.

The article focuses on the increased investment in real-world data (RWD) to enhance the quality and efficiency of drug development. Topics include the use of RWD in external control arms and biosimulation for clinical trials, the importance of data standardization for effective RWD utilization, challenges in accessing and utilizing RWD, and the role of RWD in advancing patient-centric approaches and improving clinical trials among underrepresented populations.

The article focuses on the evolving efforts to validate digital biomarkers for disease research. Topics include the potential of digital biomarkers to provide early signs and symptoms of diseases, reduce the number of patients needed for clinical trials, and the challenges associated with adopting digital biomarkers in healthcare.

The article focuses on harnessing the power of scientific surveillance in centralized monitoring of clinical trials. Topics includes the statistical methods used in centralized monitoring, application of scientific surveillance techniques, and the detection of scientific inconsistencies, risk prediction, and inflated placebo response.