When developing a health technology requiring clinical studies, developers institute working relations with clinical investigators. Patient representatives can also create and manage advisory boards with product developers. Inspired by the model of HIV research in the 1990s, EURORDIS proposes a programme of CABs.

EURORDIS invites developers to sign a Charter for collaboration with patients in clinical research, and provides guidelines together with a mentoring and training programme. CABs help set the agenda with the developer, work on topics such as study design, feasibility, informed consent, site selection, QoL and PROMs, and organize the meetings. Discussions cover compassionate use, pricing, relative efficacy, etc. There are confidentiality arrangements and minutes are taken. There are regular teleconferences for trainings and action plan updates.

As of 2019, 5 disease-specific CABs exist of approximately 12 members each and others are being formed. We have started to work on the metrics of markers of success. Evaluating the first surveys from 14 distinct CAB meetings with 19 companies shows that this form of shared decision-making is valuable as well as ethical for both parties.

Working relations continue, even when discussions become heated. All show interest in the co-creation possibilities of such collaboration and we look forward to measuring change via a Tracker. Patients see the utility and dedicate significant time and effort to this initiative during the year (with at least two grueling face-to-face meetings plus work and trainings in between). One CAB member commented, “CAB members can contribute quite more than I expected”. One sponsor suggested that they have a “renewed enthusiasm for a patient centric research and development.” This patient engagement programme, with collective thinking and exchange between patients and a collaborative mentality from both sides, ensures high quality and constructive dialogue with researchers and developers, and can eventually inform both HTA and regulatory decision-making.