Evaluation of the methodology of independent Community Advisory Boards in health products research and development: a mixed-methods cross-sectional survey study.

backgroundEUPATI Spain and EURORDIS have implemented a patient engagement model in health product research and development (R&D): international, independent Community Advisory Boards (CABs), where patients collaborate with health product companies in patient-led CAB meetings. We have evaluated the methodology of these CAB meetings.

methodsWe conducted a mixed-methods cross-sectional survey study from 2022 to 2023 to analyze the satisfaction level and perceived usefulness of CAB meetings between CAB members and company representatives across 15 CAB meetings. After each meeting, participants received an online survey comprising ten closed-ended questions on a five-point Likert scale and two open-ended questions about key takeaways and issues to improve. Written responses to open-ended questions were analyzed by AI-assisted ATLAS.ti, which categorized and quantified them semantically, and by contextual relevance and frequency. Characteristics of meetings and participants were reported, and survey responses were compared between CAB members and company representatives.

resultsMost meetings were hybrid (53.3%). A total of 252 participants attended the meetings (158 [62.7%] CAB members, 94 [37.3%] company representatives). The overall survey response rate was 54.8%, 59.5% among CAB members and 46.8% among company representatives. Most participants found the meetings useful (86.0% CAB, 93.2% company), were satisfied with the topics addressed (77.4% CAB, 93.2% company), and met their expectations (76.7% CAB, 93.2% company). Both groups considered that the company understood the CAB’s point of view (80.2% CAB, 90.9% company). Still, only 59.3% of CAB members thought the company would reconsider its plans, vs. 88.6% of company representatives. The three main takeaway areas were “Collaboration and Partnerships”, “Study Design and Protocols”, and “Communication and Education”. The main issue to improve was “Meeting Organization and Structure”.

conclusionsOverall, the satisfaction level and perceived usefulness of the CAB meetings were favorable. CAB members exhibited less favorable responses to all closed-ended questions than company representatives, especially regarding the possible influence on company actions. The open-ended responses reflected higher levels of agreement and collaboration, supporting the CAB model’s potential. Some issues, mainly related to meeting organization and the hybrid format, need improvement. Future studies are required to assess the actual impact of CAB meetings on R&D. EUPATI Spain and EURORDIS have implemented a patient engagement model in health product research and development: Community Advisory Boards (CABs). CABs are international, independent groups of patient representatives selected by their community who meet regularly with health product companies to discuss a wide range of topics, from study design to compassionate use of therapies. We have analyzed the satisfaction level and perceived usefulness of CAB meetings for CAB members and company representatives who attended 15 CAB meetings from 2022 to 2023, using a seven-minute online survey after each meeting. The survey included ten closed-ended questions and two open-ended questions on key takeaways and issues to improve. The feedback was highly positive. Most participants found the meetings useful, were satisfied with the topics addressed, and met their expectations. However, CAB members exhibited slightly less favorable responses to all closed-ended questions than company representatives, especially regarding the influence of CAB meetings on future company actions. The three main takeaway areas were “Collaboration and Partnerships”, “Study design and Protocols”, and “Communication and Education”; and the main issue to improve was “Meeting Organization and Structure”. Overall, the results were favorable. Although the closed-ended questions showed less confidence among CAB members on the future influence of the meetings, the comments from the open-ended questions reflected higher levels of agreement and collaboration and supported our CAB model’s potential. Some issues, mainly related to meeting organization and the hybrid format, need improvement. Future studies are required to assess the actual impact of CAB meetings on companies’ actions.