Authors
Adam La Caze
University of Queensland
Jon Williamson
University of Kent
Abstract
The role of mechanistic evidence tends to be under‐appreciated in current evidence‐based medicine, which focusses on clinical studies, tending to restrict attention to randomized controlled studies 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.
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DOI 10.1111/jep.12960
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References found in this work BETA

What is a Mechanism? Thinking About Mechanisms Across the Sciences.Phyllis Illari & Jon Williamson - 2012 - European Journal for Philosophy of Science 2 (1):119-135.
Diagnostic Categories in Autobiographical Accounts of Illness.Michael P. Kelly - 2015 - Perspectives in Biology and Medicine 58 (1):89-104.

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The Guidelines Challenge-Philosophy, Practice, Policy.Rani Lill Anjum, Samantha Copeland, Roger Kerry & Elena Rocca - 2018 - Journal of Evaluation in Clinical Practice 24 (5):1120-1126.
Six Theses on Mechanisms and Mechanistic Science.Stuart Glennan, Phyllis Illari & Erik Weber - 2022 - Journal for General Philosophy of Science / Zeitschrift für Allgemeine Wissenschaftstheorie 53 (2):143-161.

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