Estimating the effect of COVID-19 on trial design characteristics: a registered report. Issue 1 (11th January 2023)

• Record Type: Journal Article
• Authors: Smith, James A.; DeVito, Nicholas; Lee, Hopin; Tiplady, Catherine; Abhari, Roxanna E.; Kartsonaki, Christiana
• Is Part Of: Royal Society open science. Volume 10:Issue 1(2023)
• Publication Date: 2023-01-11
• Subjects: infectious disease -- coronavirus -- 2019-nCoV -- SARS-CoV-2 -- observational -- risk of bias; Science -- Periodicals; 500
• DOI: 10.1098/rsos.201543
• Languages: English
• ISSNs: 2054-5703

Abstract

Abstract : There have been reports of poor-quality research during the COVID-19 pandemic. This registered report assessed design characteristics of registered clinical trials for COVID-19 compared to non-COVID-19 trials to empirically explore the design of clinical research during a pandemic and how it compares to research conducted in non-pandemic times. We did a retrospective cohort study with a 1 : 1 ratio of interventional COVID-19 registrations to non-COVID-19 registrations, with four trial design outcomes: use of control arm, randomization, blinding and prospective registration. Logistic regression was used to estimate the odds ratio of investigating COVID-19 versus not COVID-19 and estimate direct and total effects of investigating COVID-19 for each outcome. The primary analysis showed a positive direct and total effect of COVID-19 on the use of control arms and randomization. It showed a negative direct effect of COVID-19 on blinding but no evidence of a total effect. There was no evidence of an effect on prospective registration. Taken together with secondary and sensitivity analyses, our findings are inconclusive but point towards a higher prevalence of key design characteristics in COVID-19 trials versus controls. The findings do not support much existing COVID-19 research quality literature, which generally suggests that COVID-19 led to a reduction in quality. Limitations included some data quality issues, minor deviations from the pre-registered plan and the fact that trial registrations were analysed which may not accurately reflect study design and conduct. Following in-principle acceptance, the approved stage 1 version of this manuscript was pre-registered on the Open Science Framework at https://doi.org/10.17605/OSF.IO/5YAEB . This pre-registration was performed prior to data analysis.