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FDA Signals Tougher Stance on Required Trial-Data Postings

FDA Signals Tougher Stance on Required Trial-Data Postings
medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.

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FDA Blazes Path for 'Real-World' Evidence as Proof of Efficacy

FDA Blazes Path for 'Real-World' Evidence as Proof of Efficacy
medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.

United States , Mayo Clinic In Rochester , New Haven , Harvard School Of Public Health , David Kerr , Adam Kroetsch , Miguela Hern , John Concato , Robert Ball , Robert Temple , Sebastian Schneeweiss , Josephs Ross , Yale School Of Medicine , Office Of Surveillance , Sansum Diabetes Research Institute In Santa Barbara , Drug Administration , Duke University Margolis Center , Regional Clinical Trials Center , Century Cures , Drug Evaluation , Duke University , Margolis Center , Like Flipping , Yale School , Century Cures Act , Multi Regional Clinical Trials Center ,

Practice Follows Principles More Inclusive Patient-Centered Development Commercialization

By Hilary Wilson, Boehringer Ingelheim, Cleonette D. Cudjoe, Patient Advocate, and Jen Horonjeff, Savvy Cooperative
Underrepresentation of Black and Indigenous people of color (BIPOC) and other racial and ethnic minorities in clinical trials is a longstanding issue. The disparate impact that COVID-19 has had on BIPOC, Hispanic, Latinx, and Asian communities, combined with the underrepresentation of these subgroups in some COVID-19 clinical trials, has brought a sense of urgency to address this historic challenge. Within the past year, the Pharmaceutical Manufacturers of America (PhRMA) released the first industry-wide principles on clinical trial diversity; the Multi-Regional Clinical Trials Center published the “Achieving Diversity, Inclusion, and Equity in Clinical Research” guidance; and the US FDA released a final guidance to encourage the inclusion of groups that are often overlooked in clinical trials. ....

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Let's Tackle The Hidden Real-World Reasons For Poor Clinical Trial Diversity

Let s Tackle The Hidden Real-World Reasons For Poor Clinical Trial Diversity
By Eleanor Perfetto, Ph.D., and Jeanne M. Regnante
Disparities in clinical research participation are well documented and, like broader healthcare disparities, a byproduct of systemic and institutional racism. COVID-19 vaccine and treatment development have greatly amplified the need for all communities to have the same opportunity to participate in research. To achieve better outcomes and health equity for historically underserved populations, we must address the not widely acknowledged, hidden, real-world reasons for such poor diversity in clinical trials. The importance is clear: People’s lives depend on it. ....

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