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

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          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.

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          The Unanticipated Consequences of Purposive Social Action

          Robert K. Merton (1936)
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            Consort 2010 statement: extension to cluster randomised trials.

            , K. Campbell, Doug G. Altman … (2011)
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              Ethical issues posed by cluster randomized trials in health research

              Charles Weijer, Jeremy M. Grimshaw, Monica Taljaard … (2011)
              The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Clin Transl Sci
                Journal ID (iso-abbrev): J Clin Transl Sci
                Journal ID (publisher-id): CTS
                Title: Journal of Clinical and Translational Science
                Publisher: Cambridge University Press (Cambridge, UK )
                ISSN (Electronic): 2059-8661
                Publication date (Electronic, collection): June 2020
                Publication date (Electronic, pub): 05 March 2020
                Volume: 4
                Issue: 3
                Pages: 229-232
                Affiliations
                [1 ]Department of Family Medicine, University of Rochester Medical Center , Rochester, NY, USA
                [2 ]Clinical Directors Network, Inc. (CDN), New York, NY, USA
                [3 ]Department of Family Medicine, University of Colorado , Boulder, CO, USA
                [4 ]Department of Medicine, University of Texas Southwestern Medical Center , Dallas, TX, USA
                [5 ]Department of Biostatistics and Computational Biology, University of Rochester Medical Center , Rochester, NY, USA
                [6 ]Department of Medicine, New York University , New York, NY, USA
                [7 ]Center for Clinical and Translational Science, The Rockefeller University , New York, NY, USA
                Author notes
                Address for correspondence: K. Fiscella, MD, MPH, Department of Family Medicine, University of Rochester Medical Center , 1381 South Ave, Rochester, NY14620, USA. Email: kevin_fiscella@ 123456urmc.rochester.edu
                Author information
                https://orcid.org/0000-0003-3613-8012
                Article
                Publisher Item ID: S2059866120000199
                DOI: 10.1017/cts.2020.19
                PMC ID: 7348012
                PubMed ID: 32695494
                SO-VID: 5c607862-89c3-4a38-8b13-a8566da71699
                Copyright © © The Association for Clinical and Translational Science 2020
                License:

                This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 20 December 2019
                Date revision received : 19 February 2020
                Date accepted : 26 February 2020
                Page count
                Tables: 1, References: 28, Pages: 4
                Categories
                Subject: Special Communications
                Subject: Implementation, Policy and Community Engagement

                Keywords: clinical trials data monitoring committee,implementation science,data and safety monitoring,delivery science,translational medical research,national institutes of health,clinical trials as topic
                Data availability:
                Keywords: clinical trials data monitoring committee, implementation science, data and safety monitoring, delivery science, translational medical research, national institutes of health, clinical trials as topic

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