Data Monitoring Committees

Data monitoring committees (DMCs), also called data and safety monitoring boards (DSMBs), were established in the early 1960s to help maintain the scientific integrity and ethical conduct of clinical trials. DMC oversight continues to increase for clinical trials sponsored by pharmaceutical and medical device companies.

A formal DMC is usually created to

  • Ensure appropriate monitoring of the safety of clinical trial participants
  • Assess whether a study should be terminated prematurely due to efficacy or futility
  • Assure the scientific validity of the clinical trial

Since the client typically does not have access to interim data results, DMC members are generally independent of anyone that is sponsoring, organizing, or conducting the clinical trial. The Food and Drug Administration (FDA) has recommended that an independent statistical group that has no other responsibilities for the clinical trial generate the reports for DMC review, allowing the client company to remain masked to any interim results.

Westat has experience providing support for DMCs in the following ways

  • Serving as the external statistical group
  • Offering administrative services such as meeting arrangements and member payments
  • Assuming contract research organization (CRO) responsibility for statistical services

In providing these services, we adhere to the regulations guiding DMC activities.

Services

  • Develop the DMC charter
  • Identify and recruit DMC members
  • Provide administrative support
  • Provide DMC meeting attendance and statistical support
  • Prepare and distribute DMC reports
  • Coordinate DMC communications