How good is "Evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of clinical utility of drugs

Naci, Huseyin ORCID: 0000-0002-7192-5751 and Ioannidis, John P. A. (2015) How good is "Evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of clinical utility of drugs. Annual Review of Pharmacology and Toxicology, 55. pp. 169-189. ISSN 0362-1642

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Identification Number: 10.1146/annurev-pharmtox-010814-124614

Abstract

Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to predict the clinical utility of drugs. The current gap between initial drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies – often creating conditions for generating favorable estimates for drug effects. There are potential solutions to improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features; reflect actual clinical practice; and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful evidence on drug effects to guide clinical decision-making.

Item Type:	Article
Official URL:	http://www.annualreviews.org/journal/pharmtox
Additional Information:	© 2014 Annual Reviews
Divisions:	LSE Health
Subjects:	H Social Sciences > HC Economic History and Conditions H Social Sciences > HN Social history and conditions. Social problems. Social reform
Date Deposited:	11 Jul 2014 11:49
Last Modified:	17 Oct 2024 02:54
Funders:	Laura and John Arnold Foundation, European Commission’s Seventh Framework Programme, Seventh Framework Programme, Laura and John Arnold Foundation
URI:	http://eprints.lse.ac.uk/id/eprint/57681

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