Aaron S. Kesselheim on Muck Rack

Aaron S. Kesselheim

Boston
As seen in: National Institutes of Health, The New York Times, Bloomberg Opinion, British Journal of Cancer, Color Research & Application, Nature, Post Outlook, The Washington Post, Washington Post Opinions, Wiley Online Library and
Professor of Medicine, Harvard Medical School; Director, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital
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Articles

EE486 SPENDING ON GENE THERAPIES FOR RECESSIVE DYSTROPHIC EPIDERMOLYSIS BULLOSA

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By Aaron S. Kesselheim, William B. Feldman, Adam J. Raymakers
| Value in Health Journal Verified
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Risk of Bias and Clinical Benefit of Phase III Trials Supporting FDA-Approved Anticancer Medicines, 2018–2025: A Cross-Sectional Analysis

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By Aaron S. Kesselheim
| European Journal of Cancer Verified
Keywords Randomised controlled trials Risk of bias Clinical benefit Cancer drugs Cochrane Risk-of-Bias Tool 2.0 European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) Get full text access Log in, subscribe or purchase for full access. References 1. Tannock, I.F. ∙ Amir, E. ∙ Booth, C.M. ... Relevance of randomised controlled trials in oncology Lancet Oncol. 2016; 17:e560-e567 2. Agrawal, S. ∙ Arora, S. ∙ Amiri-Kordestani, L. ...
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Assessing Drug Efficacy After Multiple Negative Trials—Gepirone’s Journey Through the FDA

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By Erick H. Turner, John Powers, Rosa Y. Ahn-Horst, Aaron S. Kesselheim
| JAMA Psychiatry Verified
Abstract Importance Surveys have indicated that patients and clinicians can overestimate the efficacy and safety of drugs approved by the US Food and Drug Administration (FDA). In recent years, only approximately half of new drug approvals have been based on 2 or more adequate and well-controlled trials; furthermore, regulations do not limit how many trials can be conducted or provide clear guidance on how the FDA should consider a drug with conflicting evidence of benefit from multiple trials.
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