Sponsorship, conflict of interest, risk of bias, and reporting of participant's flow and baseline demographic information in studies applicable to the federal law to post the results in clinicaltrials.gov

摘要

The US Congress passed the Food and Drug Administration Modernization Act and Amendments Act, mandating that investigators post protocols and the results of all clinical studies enrolling human subjects in the United States in the trial registry clinicaltrials.gov within 1 year after study completion [1,2]. Sponsors and principal investigators who do not comply with the federal law are subject to financial penalties up to $10,000/day for failing to register or submit the results of trials. Numerous previous analyses suggested poor compliance with this policy [3–6]. However, previous analyses were not able to precisely identify studies' applicability to federal law, because this information is not in the publicly available Web version of the trial registry, clinicaltrials.gov[4,7]. The Aggregate Analysis of ClincalTrials.gov (AACT) database enabled us to analyze the entire set of registered studies and precise information about studies' applicability to federal law. We aimed to investigate sponsor compliance with federal law to post complete high-quality information about study and participant characteristics and outcomes. We assumed noncompliance when sponsors did not post the results or posted ambiguous data. The law clearly states a sponsor's responsibility for posting timely, complete, and accurate information about the study, sponsors, investigators, and participants [1,2]. Therefore, we assumed sponsor responsibility was the sole reason and did not speculate on other reasons for not posting information about studies labeled by registry administrators as “applicable clinical trial.” We analyzed sponsorship, conflict of interest, study design and risk of bias, and reporting of participants' flow and baseline demographics based on provided information in the database extracts from the Clinical Trials Transformation Initiative (CTTI) (https://www.ctti-clinicaltrials.org/aact-database).