Presentation (CTI)

OBJECTIVES: In-trial interviews can capture patient experience data for regulatory submissions and sponsor internal decision-making on topics such as treatment efficacy, benefit-risk, meaningful change, treatment preference, disease burden, and inform clinical outcome assessment. Successful implementation necessitates cross-functional teams and meticulous execution in accordance with the regulatory requirements and local data privacy regulations. The objective is to develop an in-trial interview guidance toolkit supporting sponsor functions in implementing in-trial interviews, ensuring compliance with regulation and efficient and consistent execution across studies.
METHODS: The toolkit was developed considering relevant regulation, thought leadership and publications on in-trial interviews and organizational experience from involvement in in-trial interview studies. Key functions provided input via interviews, including clinical outcomes assessment, health economics and outcomes and value assessment, regulatory affairs, clinical operations, clinical development, patient safety, and data privacy.
RESULTS: The toolkit provides best practice recommendations and considerations for preparation, planning, execution, data analysis and reporting, and data storage. The guidance recommends sponsors to 1) Compile a central repository of clinical studies that have included in-trial interviews to facilitate continuous improvement, and 2) To create function endorsed template texts for best practice to be consistently applied (e.g., in-trial interview provider proposal, protocol text, information and consent form text, and pharmacovigilance agreement).
CONCLUSIONS: Supporting the functions that are responsible for in-trial interview implementation is essential for their high-quality adoption and ultimately supporting patient-informed drug development.