This plan was developed to help study teams design appropriate data and safety monitoring plans for research protocols. It is maintained by Clinical Research Support.
NIH Policy requires that all grantees have in place procedures for data safety monitoring of clinical trials, to insure the safety of participants and validity of data. In 1999, the NIH issued a policy requiring that a Data and Safety Monitoring Board (DSMB) be established for all phase III randomized clinical trials funded by NCI.
According to that document, the DSMB was responsible to review interim analyses of outcome data and cumulative toxicity data summaries to determine whether the trial should continue as originally designed, should be changed, or should be terminated based on these data., review reports of related studies to determine whether the monitored study needs to be changed or terminated, and review major proposed modifications to the study prior to their implementation (e.g., termination, dropping an arm based on toxicity results or other reported trial outcomes, increasing target sample size). DSMB findings would be communicated to the study leadership, and the NCI Division Director.
In their April 2001 guideline, the NCI clarifies the policy somewhat, stating that "there is no longer a blanket requirement for DSMB in the cases of low-risk behavioral and nutritional trials... All such trials should include a data and safety monitoring plan, but this may or may nor include a DSMB". This document goes on to define the Essential Elements of a DSM plan:
NIH funded phase I and II clinical trials must also have a data and safety monitoring plan, which does not necessarily include a DSMB, but which is appropriate for the "potential risks, complexity and nature of the trial."