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P201: Empowering the Next Generation of Potential iDMC Members





Poster Presenter

      Leonidas Drogaris

      • Senior Medical Director
      • Abbvie
        United States

Objectives

To promote a pool of skilled iDMC candidates, AbbVie has developed a curriculum for internal clinicians and statisticians to be able to assess unblinded clinical trial data with an emphasis on safety and compliance; evaluation of risks; and make informed recommendations for clinical trial safety.

Method

Authors: Hendrickson, B; Drogaris, L. D.; Tandon, P

Results

Initial results from these efforts have been positive based on solicited feedback.

Conclusion

Internal Data Monitoring Committees (iDMCs) have been employed at AbbVie for non-registrational studies. The iDMCs typically are tasked with periodic unblinded review of safety data but could perform interim efficacy assessments if specified by the iDMC charter. For successful execution, the iDMC charter needs to be of sufficient rigor and clarity to guide the DMC’s activities. In addition, members of an iDMC need to have the necessary expertise and a clear understanding of their roles and responsibilities. Therefore, to promote a sufficient pool of skilled candidates, AbbVie has developed a training curriculum for potential iDMC members. The internal group of clinicians and statisticians must be able to assess unblinded clinical trial data with an emphasis on safety and compliance; evaluation of risks; and making informed recommendations for clinical trial safety. An approach to training has been developed which has 3 pillars: 1) formal presentations as part of a 2 Day workshop; 2) awareness via an internal company wide global digital conference (website) along with development of a repository of key reference materials; and 3) a face to face mentoring program for potential new DMC members. Initial results from these efforts have been positive based on solicited feedback. In addition, an internal DMC charter template and work instructions, including a decision tree to guide teams on when an internal DMC may be used has been developed. In conclusion, the training and awareness program offers potential and current iDMC members a multi-faceted resource platform with access to training materials, relevant standard operating procedures, the decision tree and charter templates. Potential benefits include career development for the participants, raising the level of expertise among iDMC members and providing clear operational guidance which optimizes the functioning of the iDMCs.