Authors
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Survey Results: GCP Quality and Risks in Decentralized Clinical TrialsIdentifying and providing clarity on the GCP quality and risk concerns associated with DCT modalities.
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Considerations to Reach Underrepresented GroupsRegulatory compliance, collaboration, and effective use of technology among ways CROs can overcome challenges.
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How to Navigate the Clinical Trial Complexities in a Post-COVID WorldWith various COVID-19 vaccine trials underway, a seamless clinical research process has never been more critical.
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How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and RetentionExamining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.
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Initial Design Considerations for Immuno-Oncology TrialsPerspectives and insights regarding regulatory considerations when planning and conducting immunotherapy studies.
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How Digital Technology and Remote Assessment Strategies Can Aid Clinical Trial ResearchWhile there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
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When Trials Stumble, Mobile Research Nursing Lends a Helping HandWith the assistance of mobile research nursing, in-home visits provide solid alternative to trial participants, especially during COVID-19.
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Make Your Clinical Trial a Priority in a Busy LandscapeA more crowded space is presenting new challenges for stakeholders that must be addressed to improve efficiency.
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The Impact of Decentralized and Hybrid Trials on Sponsor and CRO CollaborationsTufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.
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Properly Training Physicians in Dermatology TrialsPoor representation of dark skin tones in textbooks emphasizes need for change.
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Better Patient Engagement Begins With Electronic Informed ConsentWhile eConsent has become more widely adopted since COVID-19, work still needs to be done in improving patients’ understanding.
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Addressing Challenges With Intelligent Point-of-Care Device DeploymentKey challenges and strategies to consider when developing devices intended for home-use or deployment in a clinical research setting.
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Changing the Face—and Faces—of Clinical ResearchThe six steps to designing a successful diversity action plan for a clinical trial protocol.
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The Importance of Simple Clinical Trial DiariesSponsors can simplify diaries by taking a closer look at the three common sources of complexity.
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Increased Digitization in Clinical Trials: Expectations for the Year AheadTop predictions for the major trends that will shape clinical trial design in 2022.
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Just How ‘Real’ is Real-World Data?Addressing sources of tension on differentiating types of data.
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Self-collection of Blood Specimens in Clinical TrialsOperational and patient burden considerations for self-collection of blood specimens in clinical trials
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Simultaneous New Drug Submissions: Is it Possible?A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.
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eSource Interoperability Between EHR and EDCEvidence from a Phase III cancer trial points to notable advances in data-transfer tech.
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Seeking Solutions for More Representative PopulationsExploring a human-centered, holistic approach for equitable trial outcomes.
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Harnessing the Power of Scientific SurveillanceStatistical methods used via this technique in centralized monitoring.
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Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
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Obtaining Informed Consent for Future Reuse of Patient DataBest practices in data re-identification and control when designing future trials.
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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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Accelerating Clinical Trial Design and OperationsFully-integrated, component-based CDMS offers flexibility, customization, and efficiency.
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Towards Data-Driven Clinical Trial Planning and StrategyOptimizing feasibility through increased data collection.
