The role of data and safety monitoring boards in implementation trials: When are they justified?

Kevin Fiscella 1, Mechelle Sanders 1, Tameir Holder 2, Jennifer K Carroll 3, Amneris Luque 4, Andrea Cassells 2, Brent A Johnson 5, Stephen K Williams 6, Jonathan N Tobin 2 7

Affiliations

PMID: 32695494
PMCID: PMC7348012
DOI: 10.1017/cts.2020.19

Free PMC article

Abstract

The National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation trials.

Keywords: Clinical trials data monitoring committee; National Institutes of Health; clinical trials as topic; data and safety monitoring; delivery science; implementation science; translational medical research.

Similar articles

Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials.
Dixon DO, Weiss S, Cahill K, Fox L, Love J, McNamara J, Soto-Torres LE.Clin Trials. 2011 Dec;8(6):727-35. doi: 10.1177/1740774511425181. Epub 2011 Oct 24.PMID: 22024105
Data safety monitoring boards: legal and ethical considerations for research accountability.
Tereskerz PM.Account Res. 2010 Jan;17(1):30-50. doi: 10.1080/08989620903520313.PMID: 20094929
Data safety and monitoring boards for African clinical trials.
Lang T, Chilengi R, Noor RA, Ogutu B, Todd JE, Kilama WL, Targett GA.Trans R Soc Trop Med Hyg. 2008 Dec;102(12):1189-94. doi: 10.1016/j.trstmh.2008.06.009. Epub 2008 Jul 21.PMID: 18644610
Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review.
Gewandter JS, Kitt RA, Hunsinger MR, Poku J, Lozano J, Chaudari J, Evans S, Gross RA, McDermott MP, Rowbotham MC, Turk DC, Dworkin RH.J Clin Epidemiol. 2017 Mar;83:101-107. doi: 10.1016/j.jclinepi.2016.12.018. Epub 2017 Jan 23.PMID: 28126598 Free PMC article. Review.
An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.
Stegert M, Kasenda B, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Briel M; DISCO study group.J Clin Epidemiol. 2016 Jan;69:152-60. doi: 10.1016/j.jclinepi.2015.05.023. Epub 2015 Jun 4.PMID: 26361993 Review.