The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O)

doi:10.1093/cid/ciab239

. 2021 Dec 6;73(11):2126-2130.

doi: 10.1093/cid/ciab239.

The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O)

Lisa Eckstein¹, Annette Rid², Dorcas Kamuya³, Seema K Shah^{4

5}

Affiliations

¹ School of Law, University of Tasmania, Hobart, Australia.
² Clinical Center Department of Bioethics & Division of AIDS, National Institutes of Health, Bethesda, MarylandUSA.
³ Health Systems and Research Ethics (HSRE) Department, Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme, Nairobi, Kenya.
⁴ Department of Pediatrics, Chicago, IllinoisUSA.
⁵ Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation (SCHORE) Center; Stanley Manne Children's Research Institute; Lurie Children's Hospital, Chicago, IllinoisUSA.

PMID: 33758912
PMCID: PMC8083612
DOI: 10.1093/cid/ciab239

The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O)

Lisa Eckstein et al. Clin Infect Dis. 2021.

. 2021 Dec 6;73(11):2126-2130.

doi: 10.1093/cid/ciab239.

Authors

Lisa Eckstein¹, Annette Rid², Dorcas Kamuya³, Seema K Shah^{4

5}

Affiliations

¹ School of Law, University of Tasmania, Hobart, Australia.
² Clinical Center Department of Bioethics & Division of AIDS, National Institutes of Health, Bethesda, MarylandUSA.
³ Health Systems and Research Ethics (HSRE) Department, Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme, Nairobi, Kenya.
⁴ Department of Pediatrics, Chicago, IllinoisUSA.
⁵ Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation (SCHORE) Center; Stanley Manne Children's Research Institute; Lurie Children's Hospital, Chicago, IllinoisUSA.

PMID: 33758912
PMCID: PMC8083612
DOI: 10.1093/cid/ciab239

Abstract

Coronavirus disease 2019 (COVID-19) vaccines are being developed and implemented with unprecedented speed. Accordingly, trials considered ethical at their inception may quickly become concerning. We provide recommendations for Data and Safety Monitoring Boards (DSMBs) on monitoring the ethical acceptability of COVID-19 vaccine trials, focusing on placebo-controlled trials in low- and middle-income countries.

Keywords: COVID-19 vaccines; SARS-CoV-2; clinical trials data monitoring committees; ethics, research; standard of care.

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Cited by

Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study.
Hinga A, Ibrahim A, Vintimilla D, Jones M, Eckstein L, Rid A, Shah SK, Kamuya D. Hinga A, et al. BMJ Glob Health. 2024 Aug 25;9(8):e015233. doi: 10.1136/bmjgh-2024-015233. BMJ Glob Health. 2024. PMID: 39182924 Free PMC article.
Ethically designing research to inform multidimensional, rapidly evolving policy decisions: Lessons learned from the PROMISE HIV Perinatal Prevention Trial.
Shah SK, London AJ, Mofenson L, Lavery JV, John-Stewart G, Flynn P, Theron G, Bangdiwala SI, Moodley D, Chinula L, Fairlie L, Sekoto T, Kakhu TJ, Violari A, Dadabhai S, McCarthy K, Fowler MG. Shah SK, et al. Clin Trials. 2021 Dec;18(6):681-689. doi: 10.1177/17407745211045734. Epub 2021 Sep 15. Clin Trials. 2021. PMID: 34524048 Free PMC article. Review.

References

1. Zimmer C, Corum J, Wee S-L. Coronavirus vaccine tracker.The New York Times. Available at: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tra.... Accessed 5 March 2021.
1. Voysey M, Clemens SAC, Madhi SA, et al. ; Oxford COVID Vaccine Trial Group . Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021; 397:99–111. - PMC - PubMed
1. Wendler D, Ochoa J, Millum J, Grady C, Taylor HA. COVID-19 vaccine trial ethics once we have efficacious vaccines. Science 2020; 370:1277–9. - PMC - PubMed
1. Rid A, Lipsitch M, Miller FG. The ethics of continuing placebo in SARS-CoV-2 vaccine trials. JAMA 2021; 325:219–20. - PubMed
1. World Health Organization Access to COVID-19 Tools Accelerator Ethics and, Governance Working Group. Emergency use designation of COVID-19 candidate vaccines: ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding. 2020; Available at: https://www.who.int/publications-detail-redirect/WHO-2019-nCoV-Policy_Br.... Accessed 22 December 2020.

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[1] Zimmer C, Corum J, Wee S-L. Coronavirus vaccine tracker.The New York Times. Available at: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tra.... Accessed 5 March 2021.

[2] Zimmer C, Corum J, Wee S-L. Coronavirus vaccine tracker.The New York Times. Available at: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tra.... Accessed 5 March 2021.

[3] Voysey M, Clemens SAC, Madhi SA, et al. ; Oxford COVID Vaccine Trial Group . Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021; 397:99–111. - PMC - PubMed

[4] Voysey M, Clemens SAC, Madhi SA, et al. ; Oxford COVID Vaccine Trial Group . Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021; 397:99–111. - PMC - PubMed

[5] Wendler D, Ochoa J, Millum J, Grady C, Taylor HA. COVID-19 vaccine trial ethics once we have efficacious vaccines. Science 2020; 370:1277–9. - PMC - PubMed

[6] Wendler D, Ochoa J, Millum J, Grady C, Taylor HA. COVID-19 vaccine trial ethics once we have efficacious vaccines. Science 2020; 370:1277–9. - PMC - PubMed

[7] Rid A, Lipsitch M, Miller FG. The ethics of continuing placebo in SARS-CoV-2 vaccine trials. JAMA 2021; 325:219–20. - PubMed

[8] Rid A, Lipsitch M, Miller FG. The ethics of continuing placebo in SARS-CoV-2 vaccine trials. JAMA 2021; 325:219–20. - PubMed

[9] World Health Organization Access to COVID-19 Tools Accelerator Ethics and, Governance Working Group. Emergency use designation of COVID-19 candidate vaccines: ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding. 2020; Available at: https://www.who.int/publications-detail-redirect/WHO-2019-nCoV-Policy_Br.... Accessed 22 December 2020.

[10] World Health Organization Access to COVID-19 Tools Accelerator Ethics and, Governance Working Group. Emergency use designation of COVID-19 candidate vaccines: ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding. 2020; Available at: https://www.who.int/publications-detail-redirect/WHO-2019-nCoV-Policy_Br.... Accessed 22 December 2020.

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The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O)

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The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O)

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