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Outsourcing Model Usage and its Relationship to Clinical Trial PerformancePilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.
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The Future of Personalized Medicine Hinges on Revolutionizing Business ModelsThe era of big pharma as product-first companies must end, as services become the larger priority.
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Trials During the Pandemic: A CRO's PerspectiveFindings from an OCT Clinical survey of researchers from 61 sites in Russia to gain the perspective of an investigator regarding clinical trials during the COVID-19 pandemic.
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The Current Status of European Research Related to COVID-19: The EUCROF PerspectiveSuccessful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.
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ROI of ePRO Use in Clinical TrialsThe cost and benefits for patients and sponsors in using ePRO versus paper
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How Remote Patient Monitoring Technology Can Impact Decentralized Clinical TrialsWhat is next for DCTs after acceleration from COVID-19?
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When Should the Audit Trail Begin?A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
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The Time Is Now: Taxation Reform for Expanded Clinical Trial AccessExpanding clinical trial access to include historically underrepresented ethnic and racial minorities means addressing root-cause barriers, including taxation.
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Insight into the New ICH E6(R3) Draft Guidance on Clinical TrialsDecentralized clinical trials have the potential to expand the number of people who can benefit from clinical trials while accelerating therapies to more patients in need.
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Examining the Impact of Exclusionary Behaviors on Team DynamicsTufts CSDD study finds that acts of microaggression negatively impact psychological safety and performance.
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What is the Current State of Remote Monitoring in Oncology Clinical Trials?Survey study of eight biopharma companies aimed to identify how often technology is being used in cancer trials.
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Connection to Communities is Key to Boosting Clinical Trial EngagementTony Clapsis, SVP and General Manager, CVS Clinical Trial Services, reflects on industry’s progress.
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Characterizing Clinical Data Management Challenges and Their Impact2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.
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Including Women of Childbearing Age in Clinical ResearchIn recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
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Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular DystrophyApproaches sponsors, CROs, and investigators can take from the DMD experience.
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5 Ways DCTs Can Positively Impact Trial DiversityCOVID-19 forces life sciences industry to make long overdue changes.
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Understanding the Complexities of Diversifying Clinical TrialsTufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.
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Employing the Power of Bayesian Methods to Expedite LearningBayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.
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AI/ML Approaches to Assisted Medical Writing—Part 2Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.
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AI and ML are Transforming Clinical Research PracticeThree case studies showcase ability of AI and ML in overcoming challenges with data, resourcing, and more.
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Trends in Radiopharmaceuticals That May Streamline Workflows, Optimize EfficiencyEnsuring equitable access to new technologies and integrating AI to benefit all communities remain critical challenges to overcome.
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Implications of the U.S. Supreme Court’s Affirmative Action Ruling for Clinical ResearchIf a future Supreme Court ruling on diversity were to be applicable to clinical research, the FDA’s positions on diversity will take on even more importance.
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Decentralized Clinical Trials: Being Audit Ready and Avoiding PitfallsSite and project management teams play major roles in risk-management and monitoring performance.
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How to Increase Engagement at Investigator MeetingsIn new age of digital, investigators must carefully create strategies to keep engagement high.
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COVID-19: A New Era for Clinical Trial Research in Europe?A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.
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The Only Thing Certain is the Uncertainty: How to Re-Plan Future Clinical Trial Enrollment in Covid-19 TimesSponsors need to develop a strategy on how to evaluate the impact of the pandemic on the re-start of halted trials.
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Tips and Tools to Overcome DE&I Challenges in Clinical TrialsNavigating FDA’s draft guidance and heightened diversity recommendations.
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A Need for ActionWhat are the necessary next steps—for all parties involved—in improving diversity in clinical trials?
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Advanced Hybrid Closed-Loop Technology Could Improve Quality of Life in Type 1 DiabetesA 1-year observational follow-up of a 3-month RCT provides insight into he benefits of advanced hybrid closed-loop system use in people with type 1 diabetes using multiple daily injections and self-monitoring of blood glucose.
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Use of Televisits in Studies and Related PV ConcernsWhile televisits can address many medical concerns, one frequent reservation expressed by healthcare professionals is that patients during these televisits tend to present too narrow a picture of their clinical condition-resulting in non-comprehensive medical assessments.
