Data and Safety Monitoring Board (DSMB) Guidelines
The DSMB should review each protocol for any major concern prior to implementation. During the trial, the DSMB should review cumulative study data to evaluate safety, study conduct, and scientific validity and integrity of the trial. As part of this responsibility, DSMB members must be satisfied that the timeliness, completeness, and accuracy of the data submitted to them for review are sufficient for evaluation of the safety and welfare of study participants. The DSMB should also assess the performance of overall study operations and any other relevant issues, as necessary.
Items reviewed by the DSMB include: Interim/cumulative data for evidence of study-related adverse events;
Interim/cumulative data for evidence of efficacy according to pre-established statistical guidelines, if appropriate;
Data quality, completeness, and timeliness;
Performance of individual centers;
Adequacy of compliance with goals for recruitment and retention, including those related to the participation of women and minorities;
Adherence to the protocol;
Factors that might affect the study outcome or compromise the confidentiality of the trial data (such as protocol violations, unmasking, etc.); and,
Factors external to the study such as scientific or therapeutic developments that may impact participant safety or the ethics of the study. The DSMB should conclude each review with their recommendations to NIDCR as to whether the study should continue without change, be modified, or terminated. Recommendations regarding modification of the design and conduct of the study could include:
Modifications of the study protocol based upon the review of the safety data;
Suspension or early termination of the study or of one or more study arms because of serious concerns about subjects’ safety, inadequate performance or rate of enrollment;
Suspension or early termination of the study or of one or more study arms because study objectives have been obtained according to pre-established statistical guidelines;
Optional approaches for NIDCR and investigators to consider when the DSMB determines that the incidence of primary study outcomes is substantially less than expected such as recommendations to increase the number of trial centers or extend the recruitment period; and,
Corrective actions regarding a study center whose performance appears unsatisfactory or suspicious.
Confidentiality must always be maintained during all phases of DSMB review and deliberations. Usually, only voting members of the DSMB should have access to interim analyses of outcome data by treatment group. Exceptions may be made when the DSMB deems it appropriate. The reason and to whom the exceptions for access to interim analyses is granted will be documented in the Closed Session Report.
https://www.nidcr.nih.gov/Research/...hers/Toolkit/DSMBGuidelines.htm
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