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 Endpoint Adjudication Committee (EAC) member using a carefully crafted process and selection criteria in order to meet specific project needs and timelines.

EAC Expertise Requirements:

  1. Therapeutic area of the adjudicated endpoint;
  2. Accurate review of patient-centered records and tabular data;
  3. Design and adherence to programmatic rules which define clinical endpoints; and
  4. Understanding of the role of an EAC within the context of the regulatory approval process.
 EAC Member Criteria:
  • Recognized competence in the area for which member is selected (typically therapeutic area), as evidenced by academic appointment or other teaching activities, relevant publications or competence; may be demonstrated by active clinical practice in the area of interest
  • Able to understand the evidence necessary to support Charter definitions in the adjudication process as evidenced academic training or fellowship in a professional society
  • Willingness to perform adjudication tasks in a timely fashion on an ongoing basis
  • Comfort making adjudication decisions using electronic media
  • Able to summarize the case and the rationale for the respective decision in a concise English narrative.

 

 EAC Chair Requirements:
  • Must meet all EAC Member Criteria requirements
  • Previous experience as an EAC member
  • Familiar with 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.