In a world where clinical evidence may be subject to changing scientific definitions and global and cultural variation, the selection of the right expert Health Care Providers (HCPs) is a critical key to the success of any committee.

ACI Clinical evaluates each potential Data Monitoring Committee (DMC) member using a carefully crafted process and selection criteria in order to meet specific project needs and timelines.

DMC Expertise Requirements:

  1. The therapeutic area of the clinical population being studied;
  2. The therapeutic area or scientific field of a presumptive safety concern;
  3. Interpretation of clinical trial data analyses; and
  4. Understanding of the role of a DMC within the context of the regulatory approval process.
 DMC Member Criteria:
  • Recognized professional accomplishment in the area for which member is selected (typically therapeutic area or clinical population being studied); evidence includes board certifications, status as Fellow in an academic society, relevant publications, academic appointment, etc.
  • Experience in clinical trials of a similar scope as the proposed DMC project evidenced by either participation as a principal investigator or an editorial/author role in the publication of clinical trial research
  • Experience in clinical practice
  • Willing, available and able to meet periodically over the course of the trial
  • Willing to meet emergently in the case of a potential trial modification.

 

 DMC Chair Requirements:
  • Must meet all requirements listed above for DMC Members
  • Prior experience as a Member on at least 2 DMCs or trial leadership committees
  • Knowledgeable about the regulatory environment related to drug development
  • Able to manage other clinical experts as evidenced by previous DMC, EAC or Trial committee chairmanships or leadership roles at academic or professional venues
  • Agreement with the sponsor about the role of the DMC and the role of the chairman.