Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study.

ABSTRACT

OBJECTIVE: To examine how and when the results of COVID-19 clinical trials are disseminated. DESIGN: Cross-sectional 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 (ie, 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 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 6 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 with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.