PharPoint has extensive experience supporting and managing Data Monitoring Committees (DMC), also known as Data and Safety Monitoring Boards (DSMB), Data Safety Monitoring Committees (DSMC), or Independent Data Monitoring Committees (IDMC).
Biostatisticians at PharPoint are routinely involved in DMCs whose outcomes may affect cohort enrollment, dose escalation/de-escalation, study modifications, and study continuation.
To overcome DMC challenges surrounding logistics and processes, PharPoint dedicates ample time to properly supporting DMC members and ensuring effective communication. This includes a training program to support members who are new to the DMC process, along with study-specific training to ensure committee needs are transparent from the start.
PharPoint’s DMC services include:
- DMC charter development, authoring, & review
- Committee member selection
- DMC member training on design and analyses interpretation
- Administrative management, including scheduling and facilitating DMC meetings
- Table, figure, and listing (TFL) preparation and distribution
- High-level summary report to accompany DMC TFL output
- Statistical design and support for mid-study adaptations and efficacy evaluations
- Archival of documentation to support Trial Master File (TMF) filing at study conclusion
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Frequently Asked Questions: Data Monitoring Committees
A clinical trial data monitoring committee, or DMC, (also known as a DSMB, IDMC, or DSMC) is an independent group that evaluates clinical trial data on an ongoing basis.
In addition to ensuring the integrity and credibility of clinical trials, DMCs safeguard the interests of study participants. As part of a DMC, committee members analyze unblinded data to provide recommendations to the sponsor as to whether to continue, modify, or stop a trial due to safety concerns, overwhelming benefit, or treatment futility.
DMCs are often used to evaluate prospective treatments that may prolong life or reduce risk of major adverse health outcomes (like cardiovascular events or the recurrence of cancer, for example).
You may want to consider a DMC if your study falls into any of the following categories:
- Your study is large and long in duration
- Your study endpoint is a highly favorable or unfavorable result
- Your patients are already very sick and have an elevated risk of death or other serious outcomes
- Your study uses an adaptive design with a planned interim analysis
- Potential risks associated with your investigational treatment are high
- The procedure to administer treatment is particularly invasive
- The population impacted is highly vulnerable (including children, pregnant people, the very elderly, and the terminally ill)
A DMC needs at least three members who are all vetted to avoid potential conflicts of interest.
Members should include at least two medical doctors with expertise within the study indication and a biostatistician. Additional members may include people associated with the pharmaceutical industry, academia, or medical establishments.
A second, non-voting biostatistician is also often included to serve as the committee’s unblinded support. An additional non-voting blinded statistician, who is typically the study statistician, may also work with the Sponsor, but not the DMC.
The DMC charter is an extensive guidance document that defines the responsibilities of the DMC. This includes detailed membership requirements, a description of data to be reviewed, and an outline of meeting processes, considerations, and committee policies.
The DMC charter should be prepared before patient recruitment processes begin. DMC charters are reviewed and signed off by all DMC members and the study Sponsor, indicating that each DMC member will conduct operations in accordance with the final charter (including any subsequent amendments).