Session (CTI)

ICH issued a draft guideline on General Considerations for Patient Preference Studies (E22) for public consultation in November 2025 with the final guideline expected in 2027. The purpose of the guideline is to “outline[s] general considerations about the use, design, conduct, analysis, and submission of PPS aimed at informing drug development, regulatory submission and evaluation, drug approvals and maintenance of such approvals”. This statement implies that regulatory bodies will consider PPE in regulatory decisions related to drugs. However, despite years of discussion related to the use of PPE to inform regulatory decisions, there are few concrete examples of drug-product decisions in which regulators acknowledged the role PPE played in the decision. The session will first introduce potential uses of PPE to inform regulatory and development decisions. According to the draft guideline, these include everything from understanding patients’ willingness to participate in clinical trials to informing selection of clinical trial endpoints, through quantitative benefit-risk assessment (Hauber – 10 minutes). The session will then review the key examples of regulatory decisions in which PPE was publicly acknowledged by regulators as being considered in decision making (Berlin – 10 minutes). The session will then present a regulatory view of the potential for PPE to inform regulatory decisions (Pignatti – 10 minutes). The final panelist (Gonzalez – 10 minutes) will describe potential methodological and procedural challenges to implementing the ICH E22 guideline which may result in developing standards for high quality research with uncertain impacts on regulatory decision-making. Panelists will then discuss the potential future of PPE in regulatory decision making.