Presentation (CTI)

OBJECTIVES: Patient preferences ensure interventions align with patient needs, satisfaction, adherence, and access. Despite their importance, they are often integrated late in the product cycle. Growing awareness has prompted regulatory agencies to develop guidelines and actively engage in collecting patient preference information. This study analyzes key regulatory guidelines on the inclusion of patient preferences in intervention development to assess the current landscape and identify the path forward.
METHODS: A desk search of the Food and Drug Administration(FDA) and European Medicines Agency(EMA) databases, along with a grey literature search, was conducted to understand current recommendations and challenges for more effective integration of patient preferences in development and access of medical interventions.
RESULTS: The search identified two key guidance from the FDA (Patient Preference Information (PPI), 2016; Draft Guidance on PPI in medical device decision making, 2024), and the PREFER recommendations. These collectively advocate for integration of patient preferences at various stages of drug and medical device development. The 2016 FDA guidance encourages sponsors to include patient preferences in their submissions, although it is not mandatory, focusing primarily on medical device decision-making. The 2024 draft guidance represents significant progress by outlining specific steps such as collecting patient preferences during the planning phase, defining study objectives and recruitment strategies, and identifying relevant subgroups. The PREFER recommendations present a globally adaptable framework, emphasizing the need to standardize methodologies for designing, conducting, and interpreting patient preference studies. They highlight the importance of involving patients earlier in the process and tailoring studies to specific healthcare and regulatory contexts.
CONCLUSIONS: Recognition of the importance of incorporating patient preferences into healthcare decision-making is growing, and regulatory agencies considering this marks a significant step forward, particularly highlighting the value of early engagement. However, challenges remain in implementing guidelines and translating them into actionable processes to ensure patients’ voices are effectively heard and considered.