Assessing the Compliance and Timeliness of Results Reporting for Clinical Trials on Antimicrobial Agents

ObjectiveAntimicrobial resistance (AMR) is an urgent global health threat, resulting in more than 5 million deaths globally in 2019. Timely and complete antimicrobial agent (AMA) clinical trial results reporting is essential to evaluate the safety and efficacy of investigational therapies. The Food and Drug Administration Amendments Act (FDAAA) of 2007 mandated results reporting for applicable clinical trials to ClinicalTrials.gov. After nearly ten years of underreporting, the HHS issued the Final Rule, requiring a designated responsible party to submit results to ClinicalTrials.gov and clarifying applicable clinical trial (ACT) criteria. ACTs and probable ACTs (pACTs) are interventional studies regulated by the FDA with at least one site based in the United States. However, pACTs were initiated prior to January 2017, when the Final Rule came into effect. This study investigates the compliance and timeliness of results reporting of ACTs and probable ACTs (pACTs) for AMAs. DesignWe extracted data from ClinicalTrials.gov for trials involving AMAs with primary completion dates between May 1, 2013, and May 1, 2023. We analyzed the time from primary completion to results reporting and estimated the hazard ratio to compare timeliness between ACTs and pACTs. Additionally, we assessed delays in reporting across different study types and funding sources. ResultsOur search resulted in 2629 NCT records. After exclusion of ineligible trials, we included 2525 trials. We found 1769 pACTs (70.1%; 95% CI, 69.3%-72.9%) and 756 ACTs (29.9%; 95% CI, 28.2%-31.8%). Among the 2525 eligible trials, 2249 trials (89.1%; 95% CI, 87.8%-90.2%) were reported on ClinicalTrials.gov or in journal publications. Overall, 81.3% (95% CI, 79.7%-82.3%) of trials were reported late or missing (75.0% of ACTs vs 83.6% of pACTs). ACTs were more likely to report results earlier than pACTs, with a hazard ratio of 1.4 (95% CI, 1.3-1.5). ConclusionsACTs demonstrated greater reporting compliance and shorter delays in the reporting of overdue results. While this analysis provides initial insights, limitations related to timeline and sample scope suggest that broader investigations are needed to fully evaluate the impact of the Final Rule.