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Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments

Rowbotham, Michael C.a,*; McDermott, Michael P.b

doi: 10.1097/PR9.0000000000000646
ACTTION Special Issue on Clinical Trials of Pain Treatments: PDF Only

Introduction: In the field of pain research, clinical trials may randomize over 500 subjects and include more than 150 sites spanning over a dozen countries.

Methods: This review examines the ethical considerations affecting clinical trial design, execution, and analysis of trials for chronic pain. The Belmont Report has been the touchstone for human studies protection efforts since 1979. Commissioned by the U.S. government in response to ethical failures in medical research, such as the Tuskegee Syphilis Study, the report emphasizes 3 basic principles: respect for persons, beneficence, and justice. Trial design and sample size have important ethical implications.

Conclusions: Measures to enhance trial transparency and combat publication and many other types of bias should be implemented.

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

aCalifornia Pacific Medical Center Research Institute, San Francisco, CA, USA

bCenter for Human Experimental Therapeutics, University of Rochester Medical Center, Rochester, NY, USA

Corresponding author. Address: California Pacific Medical Center Research Institute, 475 Brannan St, Suite 130 San Francisco, CA 94107. Tel.: 415-600-1750; fax: 415-600-1725. E-mail address: mcrowbotham@gmail.com (M.C. Rowbotham).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Received August 10, 2017

Received in revised form February 18, 2018

Accepted February 24, 2018

© 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.