To the Editor: The Commentary by Mr Miller1 highlighted the importance of public access to clinical trial protocols in the context of results disclosure on registries such as ClinicalTrials.gov. We want to emphasize 3 additional issues to consider in the path toward increased transparency in clinical trials research.
First, public access to the full original protocol and subsequent amendments is critical to the proper evaluation of results and the identification of misreporting that may occur in approximately half of industry and nonindustry trials.2 However, only trial sponsors and the US Food and Drug Administration (FDA) have access to protocols and to results for studies submitted as part of a new drug or new use application. These 2 bodies cannot reliably help patients and clinicians tailor health care decisions: sponsors have inherent conflicts of interest, and the FDA approval process requires only that trials demonstrate superiority to placebo rather than comparative effectiveness.3 Therefore, protocols should not be withheld from clinicians who prescribe and patients who are consumers of drugs and other technologies.
Chan A, Laupacis A, Moher D. Registering Results From Clinical Trials. JAMA. 2010;303(21):2138-2139. doi:10.1001/jama.2010.702