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

Abstract

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing 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%.ConclusionCOVID-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.

Results reporting for clinical trials led by medical universities and university hospitals in the Nordic countries was often missing or delayed

“…A recent study of registered Covid-19 trials found that registrations with actively updated completion status showed a higher proportion of results reported compared to others (41). We did not contact primary investigators nor sponsors to verify trial status; however, a survey in a sample of German registered trials showed only minor changes after status verification by the primary investigator (42). The planned number of participants in unreported trials is likely an overestimation compared to final enrollment (43,44), but the lack of results for their trials still reflects extensive research waste.…”

“…Our project expands the thorough manual search approach developed and validated in the respective German IntoValue project (15,16,25,26) for ClinicalTrials.gov. We further include the EUCTR, the main mandated registry of Nordic medicinal product trials, and we incorporate methods and insights from the EU Trials Tracker (8) (as further described and expanded upon by DeVito (27)) and the Dissemination of Registered COVID-19 Clinical Trials (DIRECCT) project (28,29).…”

A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform

“…The data presented is only as good as the data acquired from the registries; the ICTRP gathers records from 17 different trial registries collecting information from all around the world. Despite its importance, there are still chances to improve the consistency and quality of the data provided( 30 , 31 , 32 ). Trials’ protocols provide much more information and details on the methodology and primary outcome.…”

Transparency and reporting characteristics of COVID-19 randomized controlled trials

“…For most items, reporting did not result in major differences between reports first published as a preprint and reports first published in a peer-reviewed journal (Table 2). The reporting of harm was slightly better in peer-reviewed journal publications (21% vs 8%; absolute risk difference [95% confidence interval (CI)] 13% [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22].…”

“…The COVID-19 pandemic was also associated with a considerable increase in communication of results through preprints [13][14][15][16]. Preprints are manuscripts shared through an open-access preprint server.…”