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Independent Oversight of Clinical Trials through Data and Safety Monitoring Boards

Scott R Evans1

  • 1Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Rockville, MD.

NEJM Evidence
|February 6, 2024
PubMed

Insights

Data and Safety Monitoring Boards (DSMBs) safeguard patients in clinical trials. They monitor for efficacy, harm, or futility, ensuring trial integrity and patient welfare.

Area of Science:

  • Clinical Trials
  • Medical Ethics
  • Patient Safety

Background:

  • Interventional clinical trials require rigorous oversight to protect participant welfare.
  • Data and Safety Monitoring Boards (DSMBs) are crucial for maintaining ethical standards and scientific validity in research.

Purpose of the Study:

  • To introduce the role and importance of DSMBs in clinical research.
  • To outline the critical functions DSMBs perform throughout interventional trials.

Main Methods:

  • This article serves as an introductory review, not presenting new empirical data.
  • It synthesizes the established principles and practices of DSMB oversight.

Main Results:

  • DSMBs actively monitor patient welfare and trial progress.
  • Key monitoring areas include early efficacy, potential harm, trial futility, and evolving clinical contexts.

Conclusions:

  • DSMBs are essential for protecting patients and upholding the integrity of scientific evidence.
  • This review series will further explore the multifaceted role of DSMBs.

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