Serve On Boards To Review And Monitor Clinical Trials

Data Safety and Monitoring Board

You may not be as familiar with the role of DSMBs, also known as Data and Safety Monitoring Committees (DSMCs). A DSMB monitors the safety of study participants and the effectiveness of the study investigational therapy during a clinical trial. Members of the disease community are often a member of a DSMB for a clinical trial for their disorder.

DSMB process: DSMBs are required as part of a clinical study that poses more than minimal risk to participants.
- A DSMB provides ongoing monitoring of the progress of the trials and reviews data collected at regular intervals (interim data) throughout the trial.
- Interim data is evaluated for:
  - Participant safety.
  - Study conduct and progress.
    - For example, is data being properly collected, analyzed, reported by the correct parties, and at the frequency outlined in the protocol?
  - Effectiveness of trial investigational therapy.
- Recommendations by the DSMB regarding the trial include whether the trial should be:
  - Continued, for example if the study is progressing as expected.
  - Modified, for example, a randomized study may be changed so that all participants receive the therapy if the data find the clinical outcomes are overwhelmingly positive in the experimental arm.
  - Terminated, for example if:
    - The investigational therapy is causing harm and the risk and/or seriousness of harm outweighs long term benefits.
    - Expected benefits are not demonstrated. This could mean the control/placebo group has the same clinical outcome as the group receiving the investigational therapy.
    - There are not enough participants enrolling in the study.
    - Too many participants are withdrawing from the study.
    - The study protocol is not being followed.
- The DSMB provides recommendations to the Sponsor or a steering committee or other group delegated by the Sponsor to make decisions about the trial.
  - Strict requirements and deadlines are in place for reporting unanticipated adverse events to both the sponsor and specific regulatory agencies.
- The DSMB may have other tasks as determined by the Sponsor.
  - For example, the National Eye Institute (NEI) lists additional responsibilities for their DSMC including review and approval of the primary trial manuscript(s): NEI Guidelines for Data and Safety Monitoring of Clinical Trials
- The FDA provides more information about DSMB/DSMC in their Guidance Document: Establishment and Operation of Clinical Trial Data Monitoring Committees
- Each of the NIH Institutes may provide their own additional guidelines. For example:
  - NINDS Guidelines for Monitoring in Clinical Trials
  - NIAMS Data and Safety Monitoring Guidelines
- The Global Advocacy for HIV Prevention provides information about DSMBs in plain language in their Fact Sheet: Data Safety Monitoring Boards .
DSMB members: The Sponsor chooses members of the DSMB.
- Many Sponsors choose members from the patient community to be on the DSMB. In general, the non-scientist DSMB member would:
  - Not participate in the trial, because awareness of the accumulating data could affect compliance or other aspects of trial participation.
  - Be someone with the disease or condition under study, a close relative of such an individual, or a leader from the patient group.
- Sponsors also choose medical personnel who specialize in the disease being studied. This may include:
  - Members of your Scientific/Medical Advisory Board who are not involved in the current study.
  - Specialists in your medical network who are not involved in the current study.
DSMB appointments: Because appointments to DSMB for a clinical study are made by the study Sponsor, you may wish to contact Sponsors of upcoming clinical trials for your disease to determine how you, members of your disease community, or specialists or other medical professionals affiliated with your group may be appointed to the DSMB for the clinical trial.

Resources

Institutional Review Board

Guidance for Institutional Review Boards: Frequently Asked Questions – IRB Registration U. S. Food and Drug Administration (FDA) (link)

Guidance Document: Institutional Review Boards Frequently Asked Questions U. S. Food and Drug Administration (FDA) (link)

Recommendation on IRB Membership and Definition of Non-scientist Human Health and Services (HHS) Office of Human Research (link)

Data Safety and Monitoring Board

Guidance Document: Establishment and Operation of Clinical Trial Data Monitoring Committees U. S. Food and Drug Administration (FDA) (link)

Fact Sheet: Data Safety Monitoring Boards Global Advocacy for HIV Prevention (link)