DIA Bioethics Community Seminar

The environment surrounding clinical trials is changing dramatically due to advancements in medical technology and digital advancements. Structural changes such as GCP renovation, decentralized clinical trials (DCT), single IRBs, and secondary use of data are promoting the efficiency of clinical trials, but they are also raising fundamental questions about what should be valued in clinical trials. ICH E6(R3) and E8(R1) emphasize the importance of incorporating the perspectives of diverse stakeholders, including patients, from the planning stage of a trial. The Declaration of Helsinki also explicitly states "Meaningful Engagement," and the way we interact with patients is increasingly being positioned as an important theme in research ethics. In this context, ICH E22 was presented as a new framework for scientifically capturing patient preferences and utilizing them in decision-making in clinical trials and drug development. However, many challenges remain regarding how to understand patient preferences and experiences and to what extent they can be reflected in trials and development.

Are the data collected for the benefit of patients inadvertently becoming data that is convenient for researchers and developers? Has the mere act of "incorporating" patient feedback become the goal itself? Is it truly in the best interest of patients? We are now required to confront these questions once again.

In this session, against the backdrop of the new GCP framework, we will discuss from diverse perspectives how to incorporate patient experiences and values into clinical trials and drug development, focusing on the theme of "meaningful participation." Rather than seeking a single correct answer, we will focus on the process of aligning different values through dialogue and shaping them together, thereby considering the future of clinical trials.