The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...
FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.
Jo Varshney, PhD, DVM, discusses how VeriSIM Life’s innovative approach leverages artificial intelligence and multispecies ...
More than two years after the FDA held a public workshop on measuring overall survival (OS) in clinical cancer trials, the agency has released a draft guidance on the topic, recommending that OS be ...
The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating ...
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Company reaches FDA deal on biomarkers
A healthcare company says it has secured an agreement with the U.S. Food and Drug Administration to use 12‑month biomarker ...
Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...
Data from a major U.S. clinical trial from the Alliance for Clinical Trials in Oncology has uncovered a genetic factor that ...
The removal request is based on a ‘comprehensive review of available data’ that showed no increased risk of suicidal ideation and behavior.
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