The standing Data Safety Monitoring Board (DSMB) was established to meet the need of UTMB investigator-initiated studies requiring a DSMB. The board is tasked with providing services to ensure the ethical conduct of clinical trials and to ensure and protect the rights and safety of patients enrolled in a trial.
The DSMB is comprised of an independent panel of experts with medical, statistical, and ethics experience who review clinical study design, incidental event reports and clinical study data. If a particular expertise does not exist on the board, the board has the ability to appoint ad hoc members with the required expertise. The PI/study director may also suggest ad hoc members without a conflict of interest.
The primary purpose is to protect the research subjects through independent analysis of emerging data from the trial. This differs from adverse event reporting in that the DSMB reviews aggregate and unblinded data as it is acquired, identifies significant issues and trends during the study, and recommends changes in the study protocol.
The DSMB reviews data for both safety and efficacy. The protections afforded by this review apply to both current subjects and future subjects. The DSMB may identify the need to modify or even halt the trial over safety and ethical concerns.
In addition to the above, an independent DSMB protects the credibility of the trial by virtue of its independence from the study sponsors and helps to ensure the validity of study results by reviewing data on subject accrual and by conducting interim reviews.
It is generally expected that a DSMB will be utilized in the following situations:
- All Phase III studies require a DSMB, with the exception of low-risk behavioral and nutritional studies.
- For this discussion, "low-risk" refers to trials where subjects are expected to experience only minor side effects, and interim analyses are not crucial for the protection of the subjects.
- The involvement of a DSMB may still be requested for low-risk studies if the studies are exceptionally large, long term, and/or involve vulnerable subjects.
- Phase II clinical trials which are multicenter and randomized require a DSMB, with the exception of low-risk behavioral and nutritional studies.
- Phase II studies which are "high risk" require a DSMB.
- For this discussion, "high-risk" refers to trials of interventions associated with substantial side effects to subjects (e.g., side effects that could result in serious morbidity or death, or are irreversible), trials of diseases associated with high mortality or morbidity, and trials of highly experimental therapies (e.g., gene therapy).
- As a general guideline, DSMBs are needed for clinical trials of diseases with high mortality or morbidity, for clinical trials involving high risks, and for large, multicenter clinical trials.
- For some studies involving particularly vulnerable study participants (e.g., children or persons with impaired ability to consent), it may be beneficial to utilize a DSMB as an additional measure of subject protection.
The Office for Research Integrity and Regulatory Affairs (RIRA) offers full DSMB management services, including:
- Committee formation and appointment
- Ensuring balanced, experience committee composition
- Documenting relevant expertise and absence of conflicts of interest
- Recruiting members committed to the lifecycle of the project and with the flexibility to meet scheduling needs.
Assist with DSMB documentation:
- Study-specific Safety Monitoring Plan development;
- Reporting format for Sponsor consistent with maintenance of independence and blinding;
- Provision of reports for regulatory submissions; and
- Documentation of Committee discussions and decisions;
- Provides communication support between sponsor, PI, and DSMB members.
Data handling and management:
- Including data transfer from clinical database to independent biostatisticians