Rheumatoid Arthritis Patients’ Perspectives On The Value Of Patient Preferences In Regulatory Decision-Making During Drug Development: A Qualitative Study

Abstract

To explore how Rheumatoid Arthritis (RA) patients value the use of patient preferences in regulatory decision-making during drug development. Five semi-structured individual interviews with RA patients were conducted to gather first insights into patients’ knowledge and opinions on patient preference studies, drug development and regulatory decision-making. The results of the individual interviews were used to draft and validate the topics for the interview-guide used during four focus groups. Patients were purposively sampled from RA patients who were registered at the Swedish RA patient organization and living in Stockholm or Uppsala. Each focus group consisted of 6-8 patients (n=31 in total). All interviews were audio-recorded, transcribed verbatim and analysed using content analysis Patients think their preferences should be used in the marketing authorization processes since it is helpful to understand what the end-users of the drug want. While patients think their preferences matter, they also shared some doubts. Firstly, patients feel that preferences can only be measured when patients are well-informed about the drug and its’ different aspects. Secondly, patients are quite unsure whether regulators can rely on their stated preferences since, at this moment, they feel they might not be informed enough. Thirdly, they are unsure how and where in the marketing authorization process, patient preference information is most important to be included. According to RA patients, their preferences are valuable in regulatory decision-making during drug development. However, regulators have reasons to increase awareness among patients about why their preferences are useful, inform them about how their preferences will be measured and to ensure that all patients are well-informed when they are asked for their preferences. Acknowledgement; This work has received support from the EU/EFPIA Innovative Medicines Initiative [2] Joint Undertaking PREFER grant n° 115966.