
| 10.1371/journal.pone.0262114
http://scihub22266oqcxt.onion/10.1371/journal.pone.0262114
 35061758!8782516!35061758
free
free
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PLoS+One 2022 ; 17 (1): e0262114 Nephropedia Template TP
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How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials gov #MMPMID35061758Hutchinson N; Klas K; Carlisle BG; Kimmelman J; Waligora MPLoS One 2022[]; 17 (1): e0262114 PMID35061758show ga
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.|*COVID-19 Drug Treatment[MESH]|Antiviral Agents/*therapeutic use[MESH]|COVID-19/*epidemiology/prevention & control/virology[MESH]|Clinical Trials, Phase I as Topic/ethics[MESH]|Clinical Trials, Phase II as Topic/ethics[MESH]|Clinical Trials, Phase III as Topic/ethics[MESH]|Humans[MESH]|Patient Selection/ethics[MESH]|Practice Guidelines as Topic[MESH]|Research Design/*statistics & numerical data[MESH]
  
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