CEC Membership: Choosing the Committee

When selecting members for a Clinical Events Committee (CEC) it is so important to select individuals who can provide independent, expert, and unbiased adjudication of clinical trial events AND have the experience to understand the role of these adjudications. Here are some factors I consider when vetting potential CEC members:

1. Clinical Expertise

• Relevant Medical Specialization: The CEC should be physicians with expertise directly related to the clinical trial's indication (e.g., cardiologists for cardiovascular trials, neurologists for stroke studies) and potentially a physician with experience in the general field related to the study, depending on the needs of the study. A signed CV for each member will be collected to demonstrate this. This should be defined in the Charter (see template)

• Experience with the protocol-defined Clinical Endpoints: Look for individuals familiar with the type of events being adjudicated (e.g., MI, stroke, bleeding, death classifications). For instance, you wouldn't want a facial plastic surgeon for a breast reconstruction trial- they wouldn't be familiar with the events experienced by patients in that type of plastic surgery.

  
  

2. Regulatory and Clinical Trial Knowledge

• Familiarity with FDA/EMA guidance on adjudication processes Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees

• Understanding of trial protocols, endpoint definitions, and source documentation related to the study (medical records, discharge summaries, imaging)

  
  

3. Independence & Objectivity

• No Conflict of Interest: Must be independent, both financially and professionally, from the Sponsor, CRO, and study investigators. An FDF and conflict of interest statement will be collected to demonstrate this. This should be defined in the Charter (see template)

• Able to maintain impartiality when reviewing complex or borderline events

  
  

4. Attention to Detail

• Able to review large sets of de-identified documents and extract relevant clinical facts accurately

  
  

5. Communication & Documentation Skills

• Is decisive and can provide rationale for adjudications in a clear and concise manner

• Comfortable documenting decisions in writing

  
  

6. Availability & Reliability

• Can commit to regular review meetings or online platform work- you must clearly define the work requirements in the contract and be sure the prospective member can commit. Replacing a CEC member during the trail is disruptive.

• Responsive to timelines and able to meet deadlines

  
  

Bonus Qualities

• Prior experience serving on a CEC or DSMB

• Familiarity with Good Clinical Practice (GCP)

• Academic or clinical research experience

From experience I know that choosing the right Clinical Events Committee members is critical. Their expertise ensures that endpoint data is adjudicated consistently, independently, and in alignment with the protocol and regulatory expectations. Prioritize clinical relevance, objectivity, and reliability because ultimately your CEC’s decisions support the credibility of a study’s safety and efficacy outcomes. Invest the time to select thoughtful, experienced reviewers; if you don't, it will delay the trial and cause a lot of angst among the clinical and leadership teams.

CEC Charter Template1.docx

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