The laws and policies for informed consent and other aspects of participant safety in clinical trials receive considerable attention. Equally important are laws designed to ensure that trial participation advances medical science—because this potential benefit is what makes even the smallest set of risks acceptable. The Food and Drug Administration Amendments Act (FDAAA), subsequently clarified by 2017 regulations known as the Final Rule,1 requires trial registration and results reporting. The goal is to ensure that each trial contributes accurate and complete information to the medical evidence base—eliminating “secret trials” or biased reports with misleading conclusions.
Zarin DA, Califf RM. Trial Reporting and the Clinical Trials Enterprise. JAMA Intern Med. 2021;181(8):1131–1132. doi:10.1001/jamainternmed.2021.2041
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