BACKGROUND: Principal investigators have a responsibility to ensure and maintain the scientific integrity of their research studies and to protect the safety of the participants. Data and safety monitoring is required for all types of clinical trials, and the nature and degree of the monitoring must be related to the degree of risk involved. OBJECTIVES: This article aims to define the purpose of a data and safety monitoring board (DSMB), to describe the functions of a DSMB and distinguish them from the activities of an institutional review board, and to discuss the development and implementation of a DSMB plan. METHODS: The literature on data and safety monitoring is reviewed, and the process and key issues are illustrated with examples from the authors' clinical trial and others. RESULTS: The principal role of the DSMB is to monitor the data from the trial periodically, to review and assess the performance of its operations, and to make recommendations based on interim results (e.g., modification of the study protocol, or possible early termination of the study). Although the roles of a DSMB and institutional review board complement one another, the main focus of their responsibilities is different and carried out independently of one another. The members of a DSMB are selected on the basis of their methodologic, statistical, or clinical expertise. CONCLUSION: The multiple scientific, ethical, safety, recruitment, intervention, and budgetary responsibilities of a principal investigator can be complex. The role of the DSMB is crucial and offers independent evaluation to ensure participant safety and good science.
BACKGROUND: Principal investigators have a responsibility to ensure and maintain the scientific integrity of their research studies and to protect the safety of the participants. Data and safety monitoring is required for all types of clinical trials, and the nature and degree of the monitoring must be related to the degree of risk involved. OBJECTIVES: This article aims to define the purpose of a data and safety monitoring board (DSMB), to describe the functions of a DSMB and distinguish them from the activities of an institutional review board, and to discuss the development and implementation of a DSMB plan. METHODS: The literature on data and safety monitoring is reviewed, and the process and key issues are illustrated with examples from the authors' clinical trial and others. RESULTS: The principal role of the DSMB is to monitor the data from the trial periodically, to review and assess the performance of its operations, and to make recommendations based on interim results (e.g., modification of the study protocol, or possible early termination of the study). Although the roles of a DSMB and institutional review board complement one another, the main focus of their responsibilities is different and carried out independently of one another. The members of a DSMB are selected on the basis of their methodologic, statistical, or clinical expertise. CONCLUSION: The multiple scientific, ethical, safety, recruitment, intervention, and budgetary responsibilities of a principal investigator can be complex. The role of the DSMB is crucial and offers independent evaluation to ensure participant safety and good science.