Medication non-adherence poses a significant challenge in clinical trials, leading to biased results, compromised study outcomes, and increased costs. This forum, organized by the ISPOR Medication Adherence and Persistence Special Interest Group, will offer a comprehensive overview of current guidelines from the European Medicines Agency (EMA) regulatory authority and health technology assessment (HTA) bodies. It will also cover best practices for defining, measuring, and reporting medication adherence in clinical trials.

The forum will begin by highlighting the importance of medication adherence in clinical trials, discussing the critical role it plays and the consequences of neglecting this issue. It will then provide an overview of the current regulations from the EMA and leading HTA bodies in the EU regarding approaches to considering medication adherence in clinical research. To offer practical guidance, the forum will introduce the ABC Taxonomy for Medication Adherence, which includes recommendations on defining medication adherence. Additionally, the Timelines-Events-Objectives-Sources (TEOS) Framework will be presented to guide the operationalization of medication adherence concepts in clinical research. The discussion will then shift to promoting transparent reporting methods, based on the International Society for Medication Adherence (ESPACOMP) Medication Adherence Reporting Guideline (EMERGE), to ensure clarity and accuracy in adherence data reporting.

The forum will utilize case studies to highlight common problems associated with medication non-adherence in clinical trials and provide examples of successful strategies to address these issues. Real-time polling will be used throughout the forum to facilitate interactive audience discussions on the challenges of medication adherence in clinical research. Participants will be encouraged to share their experiences and perspectives. The concluding segment of the forum will allow time for wrap-up and provide opportunities for questions and answers. This will enable attendees to clarify any doubts and reinforce their understanding of the key points discussed.