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Normative arguments and new solutions for the unbiased registration and publication of clinical trials


Strech, Daniel (2012). Normative arguments and new solutions for the unbiased registration and publication of clinical trials. Journal of Clinical Epidemiology, 65(3):276-281.

Abstract

Objective: To present a structured account of ethical problems and possible solutions related to selective publication and incomplete trial registration.
Study Design and Setting: The presentation of ethical problems and possible solutions is structured using the tools of conceptual normative analysis.
Results: Selective publication runs contrary to (1) principles of ethical research, such as social value and respect for participants, (2) sound medical decision making and clinical guideline development, (3) appropriate patient information, (4) public trust in clinical research, and (5) just allocation of public resources for clinical research. Reasons against the obligation of complete registration and publication of trials can be divided into (1) protection of private data and (2) commercial interests. Empirical findings indicate that selective publication and incomplete trial registration (1) are frequent, (2) extensively distort patient-relevant outcomes, and (3) affect a large number of patients.
Conclusion: Empirical data and normative arguments outweigh their counterarguments and present a clear case in favor of an even more restrictive obligation to register trials. Institutional review boards and better-educated stakeholders might play a crucial role in facilitating unbiased registration and publication of clinical research. For evaluation purposes, the field needs better standards for study protocols.

Abstract

Objective: To present a structured account of ethical problems and possible solutions related to selective publication and incomplete trial registration.
Study Design and Setting: The presentation of ethical problems and possible solutions is structured using the tools of conceptual normative analysis.
Results: Selective publication runs contrary to (1) principles of ethical research, such as social value and respect for participants, (2) sound medical decision making and clinical guideline development, (3) appropriate patient information, (4) public trust in clinical research, and (5) just allocation of public resources for clinical research. Reasons against the obligation of complete registration and publication of trials can be divided into (1) protection of private data and (2) commercial interests. Empirical findings indicate that selective publication and incomplete trial registration (1) are frequent, (2) extensively distort patient-relevant outcomes, and (3) affect a large number of patients.
Conclusion: Empirical data and normative arguments outweigh their counterarguments and present a clear case in favor of an even more restrictive obligation to register trials. Institutional review boards and better-educated stakeholders might play a crucial role in facilitating unbiased registration and publication of clinical research. For evaluation purposes, the field needs better standards for study protocols.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Biomedical Ethics and History of Medicine
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2012
Deposited On:11 Feb 2013 16:14
Last Modified:07 Dec 2017 18:51
Publisher:Elsevier
ISSN:0895-4356
Publisher DOI:https://doi.org/10.1016/j.jclinepi.2011.07.002

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