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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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Innovations in Data Capture Transforming Trial DeliveryAdvances in technology open door for improved EHR to EDC transfer process.
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Navigating Clinical Trial Recruitment in the Midst of COVID-19Many companies during this time of social distancing have paused trial recruitment completely to focus on currently recruited patients, while others rethink their strategy to better accommodate the new digital-only reality.
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What’s Complicating Good Data Practices and Data Integrity?Companies must be able to defend the fidelity and confidentiality of all records and data generated throughout a product’s entire lifecycle, starting with the earliest points in research.
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FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug DevelopersJanuary 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.
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Integration of Biomarker Validation in Oncology TrialsRecent case study highlights the importance of applying statistical rigor throughout the development and validation processes of biomarkers.
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Evolution of the UK Legislative Framework for Clinical TrialsNew proposals aim to create higher standards for trial regulation.
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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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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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Aligning Patient Burden with Planetary BurdenHow making trial participation easier can reduce the impact on the environment.
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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.
