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FDA Guidance Takes Aim at ClinicalTrials.gov Transgressors

The U.S. Food and Drug Administration (FDA) has issued a final guidance on “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” outlining the agency’s current thinking regarding penalties imposed on responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate federal requirements to […]

ACRPtv — Spotlight On…Promoting Diversity in Covid-19 Trials

Featuring Dr. Christina Brennan, VP, Clinical Research, Northwell Health “We were the epicenter of the [COVID-19] epicenter,” Dr. Brennan recalls in our August 10, 2020 discussion. She shares lessons learned managing massive clinical trials designed to help battle the pandemic over the past several months. Dr. Brennan also talks about the importance of improving diversity […]

True Patient-Centric Trials Demand Full Industry Participation

All of those lofty goals and high aspirations associated with the term “patient centricity” won’t meet their potential unless all stakeholders come together to swap ideas, confront challenges, and share best practices, says Steve Whittaker, president of PharmaPM Consulting and moderator of the upcoming Quality Congress program co-sponsored by the Association of Clinical Research […]

The Critical Need for Transparency and Disclosure of Participant Diversity in Clinical Trials

Clinical Researcher—August 2020 (Volume 34, Issue 7) PEER REVIEWED Yaritza Peña; Zachary P. Smith; Kenneth A. Getz, MBA   It is well known that the underrepresentation of minority groups in clinical trials decreases the generalizability of clinical trial findings by disguising the potential effects of variation in the pathobiology of disease and race-related differences in […]