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Trust but Verify: Trial Registration and Determining Fidelity to the Protocol

Deborah A. Zarin, MD; and Tony Tse, PhD
[+] Article, Author, and Disclosure Information

From National Library of Medicine, Bethesda, Maryland.

Disclaimer: The ideas and opinions expressed are the authors. They do not represent any policy position of the National Institutes of Health, Public Health Service, or Department of Health and Human Services.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1109.

Requests for Single Reprints: Deborah A. Zarin, MD, Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicine, National Institutes of Health, 8600 Rockville Pike, Bethesda, MD 20894; e-mail, dzarin@mail.nih.gov.

Current Author Addresses: Drs. Zarin and Tse: Lister Hill National Center for Biomedical Communications, U.S. National Library of Medicine, National Institutes of Health, 8600 Rockville Pike, Bethesda, MD 20894.

Ann Intern Med. 2013;159(1):65-67. doi:10.7326/0003-4819-159-1-201307020-00011
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Clinical trials, like all scientific experiments, are guided by protocols that outline the study design, conduct, and analysis. Deviations from the protocol that cannot be scientifically justified are worrisome because they could undermine the validity of the study or analysis. The editorialists discuss 2 recent Annals letters that address this problem.


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