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Institutionally chartered Data and Safety Monitoring Boards: structured approaches to assuring participant safety in clinical research
  1. Blair Holbein1,
  2. Marie T Rape2,
  3. Barbara N Hammack3,
  4. Ann Melvin4,5,
  5. Carson Reider6,
  6. Tamsin A Knox7,8
  1. 1 Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA
  2. 2 North Carolina Translational and Clinical Sciences Institute, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA
  3. 3 Colorado Clinical & Translational Sciences Institute, University of Colorado Denver – Anschutz Medical Campus, Aurora, Colorado, USA
  4. 4 Department of Pediatrics, Division of Pediatric Infectious Disease, University of Washington and Seattle Children's Research Institute, Seattle, Washington, USA
  5. 5 Institute of Translational Health Sciences, University of Washington, Seattle, Washington, USA
  6. 6 College of Public Health, The Ohio State University OSUMC, Columbus, Ohio, USA
  7. 7 Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts, USA
  8. 8 Tufts Clinical and Translational Science Institute, Tufts University School of Medicine, Boston, Massachusetts, USA
  1. Correspondence to Dr Ann Melvin, Division of Pediatric Infectious Disease, Department of Pediatrics, University of Washington Seattle Campus, Seattle, Washington, USA; ann.melvin{at}seattlechildrens.org

Abstract

Data and Safety Monitoring Boards (DSMBs) derived from the need to monitor large federally funded multi-center clinical trials and evolved to include commercial and other large and complex trials. Eventually, academic health centers also created institutionally focused trial monitoring mechanisms. The basic general principles that define traditional DSMBs extend to the institutional level. The primary responsibilities are assuring safety of the participants, preserving the integrity of the trial, and ensuring the reliability of the results. Institutionally chartered DSMBs meet these responsibilities but usually have fewer members, have a structure specific to the needs of the trial, are more focused and/or have different scope reviewing smaller, single site, higher risk, and investigator-initiated studies and are flexible to accommodate institution-specific requirements and approaches. Their purpose is to meet the responsibilities of oversight for safety and data integrity, ensure proper study design, rigor and conduct, as well as provide statistical support appropriate to the setting of the research. Academic health centers should recognize the importance and existence of institution level safety and data monitoring and provide support as much as possible. Investigators should have sufficient resources available to assemble DSMBs. The Clinical and Translational Science Awards Collaborative DSMB Workgroup provides an online manual to assist investigators.

  • public policy
  • research

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Footnotes

  • Deceased BH deceased; TAK deceased

  • Contributors All listed authors contributed to the planning, conduct in the form of workgroup contributions and DSMB manual authoring, and in the reporting of the contents of this manuscript.

  • Funding This publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Numbers UL1 TR002489 (North Carolina), UL1 TR002535 (Colorado), UL1 TR002319 (Seattle), UL1 TR002544 (Tufts), and National Cancer Institute P30 CA142543 (Dallas).

  • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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