Recruitment and Results Reporting of COVID-19 Randomized Clinical Trials Registered in the First 100 Days of the Pandemic

Janiaud, Perrine; Axfors, Cathrine; Ioannidis, John P. A.; Hemkens, Lars G.

doi:10.1001/jamanetworkopen.2021.0330

Cited by 21 publications

(26 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite elevated SARS-CoV-2 cases, many trials (22.6% (113 of 500 trials)) were unable to adequately and expeditiously complete patient-participant recruitment. This estimate is in keeping with other studies in which close to one third of COVID-19 trials registered on Clini-calTrials.gov or on the World Health Organization International Clinical Trials Registry Platform stopped before attaining 75% accrual [27]. In some cases failure to reach recruitment goals can be explained by decreasing case counts in the setting of rapid suppression of a COVID outbreak.…”

Section: Plos Onesupporting

confidence: 86%

How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials.gov

et al. 2022

View full text Add to dashboard Cite

Background Early in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic. Methods Based on prespecified eligibility criteria, we created a cohort of Phase 1/2, Phase 2, Phase 2/3 and Phase 3 SARS-CoV-2 treatment and prevention efficacy trials that were initiated from 2020-01-01 to 2020-06-30 using ClinicalTrials.gov registration records. We excluded trials evaluating behavioural interventions and natural products, which are not regulated by the U.S. Food and Drug Administration (FDA). We evaluated trials on 3 criteria of informativeness: potential redundancy (comparing trial phase, type, patient-participant characteristics, treatment regimen, comparator arms and primary outcome), trials design (according to the recommendations set-out in the May 2020 FDA guidance document on SARS-CoV-2 treatment and prevention trials) and feasibility of patient-participant recruitment (based on timeliness and success of recruitment). Results We included all 500 eligible trials in our cohort, 58% of which were Phase 2 and 84.8% were directed towards the treatment of SARS-CoV-2. Close to one third of trials met all three criteria and were deemed informative (29.9% (95% Confidence Interval 23.7–36.9)). The proportion of potentially redundant trials in our cohort was 4.1%. Over half of the trials in our cohort (56.2%) did not meet our criteria for high quality trial design. The proportion of trials with infeasible patient-participant recruitment was 22.6%. Conclusions Less than one third of COVID-19 trials registered on ClinicalTrials.gov during the first six months met all three criteria for informativeness. Shortcomings in trial design, recruitment feasibility and redundancy reflect longstanding weaknesses in the clinical research enterprise that were likely amplified by the exceptional circumstances of a pandemic.

show abstract

Section: Plos Onesupporting

confidence: 86%

How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials.gov

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Of the 516 trials in their sample, 155 (30%) had not started or were discontinued, per either the registry or trial team outreach. 36 Open access…”

Section: Research In Contextmentioning

confidence: 99%

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

et al. 2021

View full text Add to dashboard Cite

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.

show abstract

“…Of the subset of 210 Phase 2/3 and Phase 3 trials in our cohort, 92 (43.8%) met our criteria for trial design quality 20 (Figure 1; Table 2). The proportion of feasible trials in our cohort was 77.4% (387 of 500 trials); 113 trials were non-feasible.…”

Section: Resultsmentioning

confidence: 99%

“…This estimate is in keeping with other studies in which close to one third of COVID-19 trials registered on ClinicalTrials.gov or on the World Health Organization International Clinical Trials Registry Platform stopped before attaining 75% accrual. 20 In some cases failure to reach recruitment goals can be explained by decreasing case counts in the setting of rapid suppression of a COVID outbreak. For example, early stoppage of a Remdesivir multicenter randomized controlled trial after recruitment of 237 of 453 patient-participants in Wuhan, China, resulted in an underpowered trial with inconclusive results.…”

Section: Discussionmentioning

confidence: 99%

How Informative Were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov

Hutchinson

Klaś

Carlisle

et al. 2021

Preprint

View full text Add to dashboard Cite

Background Early in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic. Methods We created a cohort of SARS-CoV-2 treatment and prevention efficacy trials that were initiated from 2020-01-01 to 2020-06-30 using ClinicalTrials.gov registration records. We evaluated trials on 3 criteria of informativeness: potential redundancy, design quality and feasibility of patient-participant recruitment. The study protocol was prospectively registered with the Open Science Framework (https://osf.io/fp726/). Results We included 500 trials in our cohort, 58% of which were Phase 2 and 84.8% were directed towards the treatment of SARS-CoV-2. Close to one third of trials met all three criteria and were deemed informative (29.0% (95% Confidence Interval 23.7-36.9)). The proportion of potentially redundant trials in our cohort was 4.1%. Over half of the trials in our cohort (56.2%) did not meet our criteria for high quality trial design. The proportion of trials with infeasible patient-participant recruitment was 22.6%. Conclusions Less than one third of COVID-19 trials registered on ClinicalTrials.gov during the first six months met all three criteria for informativeness. Shortcomings in trial design, recruitment feasibility and redundancy reflect longstanding weaknesses in the clinical research enterprise that were likely amplified by the exceptional circumstances of a pandemic.

show abstract

Recruitment and Results Reporting of COVID-19 Randomized Clinical Trials Registered in the First 100 Days of the Pandemic

Abstract: This survey analysis of randomized clinical trials registered within 100 days of the first reported case of coronavirus disease 2019 assessed recruitment and results reporting.

Cited by 21 publications

References 5 publications

How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials.gov

How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials.gov

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

How Informative Were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov

Contact Info

Product

Resources

About