FEATURED ARTICLES
Why Site Engagement Isn't Just A Role Anymore
GSK’s Laura O'Donnell says site engagement is no longer just a function or team, it’s an organization-wide capability. In this article, she discusses why the traditional CRA relationship model has broken down, how sponsors are using data and AI to better support sites, and why human connection still matters in an increasingly automated clinical trial environment.
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Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It
Standard methods for evaluating clinical trial representativeness perform poorly when the trial population differs from the broader disease population in a patient registry. June Cha, Ph.D., MPH, explains how the right metrics can make a difference.
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A Biomarker Playbook For Building Faster, Smarter Clinical Trials
Not every trial needs a biomarker, but every development leader should be assessing whether they can be effectively used to improve trial design, boost enrollment, reduce operational waste, and increase the likelihood that a study will answer the question it was built to answer.
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ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity
Coya Therapeutics' Fred Grossman dives into innovative trial design elements and a novel biomarker that might better account for clinical and functional progression in Coya's ALS trial studying a dual immunomodulatory therapy.