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Clinical Evidence in FDA Drug Approvals Varies Widely, Study Finds
Not every new drug approved by the U.S. Food and Drug Administration has undergone the rigorous clinical testing that physicians and their patients might expect, according to new research.
Not every new drug approved by the U.S. Food and Drug Administration has undergone the rigorous clinical testing that physicians and their patients might expect, according to new research.
A study published Tuesday in the Journal of the American Medical Association finds that the FDA has “flexible standards” for approving of new therapies. Using publicly available information from the FDA drug database, investigators identified 188 novel therapies for treating 206 conditions approved between 2005 and 2012. Of these, 37% were approved on the basis of a single clinical trial, 38% on the basis of two trials and 25% had been tested in three or more trials.
Although most therapies were supported by at least one randomized, double-blind trial—the gold standard for clinical research—there was wide variation in the duration, size and completion rates. Comparative-effectiveness data was available for less than half of the indications.
Read the full story here: http://bit.ly/KGzKqC
Source: Modern Healthcare
Frameworks for Advancing Health Equity: Urban Health Outreach
May 9th 2024In the series debut episode of "Frameworks for Advancing Health Equity," Mary Sligh, CRNP, and Chelsea Chappars, of Allegheny Health Network, explain how the Urban Health Outreach program aims to improve health equity for individuals experiencing homelessness.
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Real-World Data Show Sotorasib Effective for NSCLC With KRAS Mutation
May 18th 2024Data from real-world and clinical-trial settings on frontline monotherapy treatment with the KRAS inhibitor sotorasib both show similar progression-free survivals and a high likelihood that the treatment’s efficacy is not affected with dose reduction.
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