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The use of evidence of mechanisms in drug approval

Aronson, Jeffrey, La Caze, Adam, Kelly, Michael, Parkkinen, Veli-Pekka, Williamson, Jon (2018) The use of evidence of mechanisms in drug approval. Journal of Evaluation in Clinical Practice, . ISSN 1356-1294. E-ISSN 1365-2753. (doi:10.1111/jep.12960) (KAR id:66978)

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The role of mechanistic evidence tends to be under?appreciated in current evidence?based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. Drug approval is a problematic case for the view that mechanistic evidence should be taken into account, because RCTs are almost always available. Nevertheless, we argue that mechanistic evidence is central to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost?effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies.

Item Type: Article
DOI/Identification number: 10.1111/jep.12960
Subjects: B Philosophy. Psychology. Religion > B Philosophy (General)
R Medicine > R Medicine (General)
Divisions: Divisions > Division of Arts and Humanities > School of Culture and Languages
Depositing User: Jon Williamson
Date Deposited: 10 May 2018 11:44 UTC
Last Modified: 04 Jul 2023 10:50 UTC
Resource URI: (The current URI for this page, for reference purposes)

University of Kent Author Information

Parkkinen, Veli-Pekka.

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Williamson, Jon.

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