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FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law Blog

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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Episode 240: Anti-Racism in Medicine Series – Episode 17 – ‘Just’ Births: Reproductive Justice & Black/Indigenous Maternal Health Equity

The Clinical Problem Solvers

This discussion is hosted by Naomi Fields, MD, Chioma Onuoha, and Victor Lopez-Carmen MPH, as they interview Dr. Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center.

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A Podcast on Inhalant Misuse: From Glue to Galaxy Gas

PEMBlog

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. References Perry H, Burns MM. Ganetsky M (ed).

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The Future of Geriatrics: A Podcast with Jerry Gurwitz, Ryan Chippendale, and Mike Harper

GeriPal

We have the new geriatric surgical verification process where they’re, I think now eight or so level one geriatric surgical centers with 40 more somewhere in that process of becoming certified. And he asked me questions like, “Why is this patient in bed? So now we have geriatric emergency departments. Oh, woe is us.

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Trump Whacks Agency That Makes the Nation’s Health Care Safer

Physicians News Digest

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.