COVID-19 drug research and the cohort multiple randomised controlled trial design
Rafael Dal-Ré, Rafael Dal-Ré
Abstract
In the cohort multiple randomised controlled trial design, consent is not sought from control group participants in each trial conducted within the cohort, so it is ethically inappropriate for assessment of medicinal products in COVID-19 patients https://bit.ly/3xtBX3m
Trial registration: ClinicalTrials.gov NCT04324047.
Conflict of interest statement
Conflict of interest: None declared.
References
- Nasrallah AA, Farran SH, Nasrallah ZA, et al. . A large number of COVID-19 interventional clinical trials were registered soon after the pandemic onset: a descriptive analysis. J Clin Epidemiol 2020; 125: 170–178. doi:10.1016/j.jclinepi.2020.06.005
- Hermine O, Mariette X, Tharaux PL, et al. . Effect of tocilizumab vs usual care in adults hospitalized with COVID-19 and moderate or severe pneumonia: a randomized clinical trial. JAMA Intern Med 2021; 181: 32–40. doi:10.1001/jamainternmed.2020.6820
- CORIMUNO-19 Collaborative group . Effect of anakinra versus usual care in adults in hospital with COVID-19 and mild-to-moderate pneumonia (CORIMUNO-ANA-1): a randomised controlled trial. Lancet Respir Med 2021; 9: 295–304. doi:10.1016/S2213-2600(20)30556-7
- CORIMUNO-19 Collaborative group . Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): an open-label randomised controlled trial. Lancet Rheumatol 2022; 4: e24–e32. doi:10.1016/S2665-9913(21)00315-5
- Hermine O, Mariette X, Porcher R, et al. . Tocilizumab plus dexamethasone versus dexamethasone in patients with moderate-to-severe COVID-19 pneumonia: a randomised clinical trial from the CORIMUNO-19 study group. eClinicalMedicine 2022; 46: 101362. doi:10.1016/j.eclinm.2022.101362
- Hermine O, Mariette X, Porcher R, et al. . Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group. Eur Respir J 2022; 60: 2102523.
- Relton C, Torgeson D, O'Cathain A, et al. . Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design. BMJ 2010; 340: c1066. doi:10.1136/bmj.c1066
- Weijer C, Goldstein CE, Taljaard M. TwiC or treat? Are trials within cohorts ethically defensible? Clin Trials 2018; 15: 21–24. doi:10.1177/1740774517746622
- World Medical Association . Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 64th General assembly, Fortaleza, Brazil, October 2013. Date last accessed: 8 April 2022.
- Council for International Organizations of Medical Sciences (CIOMS) . International Ethical Guidelines for Health-related Research Involving Humans. Geneva, 2016.
Source: PubMed