Nonregulated Interventions, Clinical Trial Registration, and Editorial Responsibility: A New Crossroads for Journals

摘要

Venues for peer-reviewed publication continue to grow, and the availability of new data and data sources is expanding. The ongoing conversation regarding how to ensure scientific rigor and transparency continues to be refined. The quality of scientific reporting can and should be questioned to ensure the reproducibility, accuracy, and reliability of empirical inquiry. An ongoing challenge, however, is precisely calibrating administrative burdens that might slow innovation with critical protections for research participants, as well as research integrity. One important area of such inquiry is the prospective registration of clinical trials. The goals of prospective registration include reducing the risk of biases introduced by selective or nonreporting of research results and avoiding redundancy by informing the larger scientific community of the work while in progress. Past analysis of this topic has focused on the prospective registration of regulated trials specifically. For example, the US Food and Drug Administration (FDA), requires the prospective registration of drugs, biologics, and device trials, which aspire to collect data for future regulated medical products, as applicable clinical trials. As a funding agency, the National Institutes of Health can also require that "sponsored interventional studies with biomedical outcomes" (even those with interventions that will not later be FDA regulated) be registered with https://www. clinicaltrials.gov within 21 days of enrollment of the first participant.3 The FDA and National Institutes of Health systems working in tandem effectively serve as both a carrot and stick for ensuring that researchers adhere to regulatory requirements for human subjects research and research integrity.