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Aaron S. Kesselheim
Brigham and Women's Hospital
450Publications
42H-index
6,336Citations
Publications 458
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#1Emily H. Jung (Brigham and Women's Hospital)H-Index: 1
#2Ameet Sarpatwari (Brigham and Women's Hospital)H-Index: 12
Last.Michael S. Sinha (Harvard University)H-Index: 4
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Abstract Objective To evaluate trends in the clinical development of new pain and reformulated pain medications given the ongoing opioid crisis and the public health burden of inadequately controlled pain. Methods We conducted a retrospective cohort study of new drugs starting clinical testing between January 1, 2000, and December 31, 2015. We searched two comprehensive commercial databases of global research and development activity. The primary outcomes were trends in new and reformulated pain...
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Importance Regulatory and scientific guidelines stipulate that indirect, surrogate measures of patient benefit, such as a change in microbial culture status, should be used as primary end points only in pivotal trials of chronic conditions that are serious or life threatening and when the experimental therapy is expected to offer substantial benefit compared with available therapy. However, many recent US Food and Drug Administration (FDA) anti-infective drug approvals for acute and/or non–life-...
1 CitationsSource
The U.S. Insulin Crisis The members of the team that discovered insulin sold the patent to the University of Toronto for $1 each because they felt that the drug belonged to the public. Nearly 100 y...
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#1Michael A. Fischer (Brigham and Women's Hospital)H-Index: 39
#2Aaron S. Kesselheim (Brigham and Women's Hospital)H-Index: 42
Last.Jerry Avorn (Brigham and Women's Hospital)H-Index: 112
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BACKGROUND: Step therapy policies that require prescribers to follow an ordered protocol for drug choices are widely used by public and private insurers to manage medication costs; however, the per...
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