Results Availability and Timeliness of Registered COVID-19 Clinical Trials: A Cross-Sectional Study

Abstract

Objective: To examine how and when the results of COVID-19 clinical trials are disseminated Design: Cross-sectional bibliographic study Setting: The COVID-19 clinical trial landscape Participants: 285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020 Main outcome measures: Overall reporting and reporting by dissemination route (i.e., by journal article, preprint, or results on a registry); time to reporting by dissemination route. Results: Following automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n = 25) followed by journal articles (n = 18), and results on a registry (n = 2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates available and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%. Conclusion: COVID-19 trials completed during the first six months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared to non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data is accurate should be a priority for the research community during a pandemic. Data collection is underway for Phase 2 of the DIRECCT study expanding our trial population to those completed anytime in 2020.