A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes.

Abstract

BACKGROUND Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real… (More)

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