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Regulators should better leverage effectiveness standards to enhance drug value

Naci, Huseyin and Alexander, George Caleb (2014) Regulators should better leverage effectiveness standards to enhance drug value. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 34 (10). pp. 1005-1011. ISSN 0277-0008

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Identification Number: 10.1002/phar.1467


Regulators show some flexibility in the evidentiary standards of effectiveness that must be demonstrated for a drug prior to its market authorization. Adopting a more formal framework for when and how effectiveness standards should vary would improve the therapeutic value of new medicines at the time of market entry. We identify three factors-the number and effectiveness of existing treatment alternatives, magnitude of unmet need, and expected clinical application-to guide the effectiveness threshold for a given therapy. Using these factors, regulators should actively guide sponsors regarding appropriate comparators and end points in pivotal trials, as well as determining the size and characteristics of the patient populations enrolled.

Item Type: Article
Official URL:
Additional Information: © 2014 Pharmacotherapy Publications, Inc.
Divisions: LSE Health
Subjects: H Social Sciences > H Social Sciences (General)
JEL classification: I - Health, Education, and Welfare > I1 - Health > I11 - Analysis of Health Care Markets
Date Deposited: 08 Aug 2014 11:08
Last Modified: 20 Oct 2021 02:11
Projects: RO1 HS0189960
Funders: United States Agency for Healthcare Research and Quality

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