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FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.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 The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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Is Hospice Losing Its Way: A Podcast with Ira Byock and Joseph Shega

GeriPal

I think some individuals thought there was cherry-picking of stories that made it seem like hospice is this bad thing, that it’s taking advantage of vulnerable individuals and it didn’t talk enough about the good things that hospice does. And that’s an ADC of two to three patients a day. Eric: Great.

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A Podcast on Inhalant Misuse: From Glue to Galaxy Gas

PEMBlog

Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Inhalant misuse reported to Americas Poison Centers, 2001-2021. Patients that use these will repeatedly use it throughout the day. If the patient is unconscious and in a tachyarrhythmia, the treatment is electricity!

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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.