The initiative was founded on the belief that patients are equal stakeholders in the drug development process and that the interests of all stakeholders have merit and must be addressed. As such, the first step in any patient engagement initiative is to bring together all stakeholders in clinical research and drug development to discover these often unexamined interests, assumptions, judgments and ways of thinking held by each stakeholder group in drug development. Once they are surfaced a discussion and realistic negotiation of what the role of patient in research should look like can be undertaken and the methodologies needed to implement that role.
1. Discover and share the world views, including challenges, regarding patient engagement possessed by each of the stakeholder groups within clinical research.
2. Establish methodologies to permanently bring that ability to surface and use this multi-stakeholder world view understanding of patient engagement into everyday decision situations in clinical research, whether regarding protocol design, support for patients in trials, sharing of patient data, ownership of patient data, bridging gaps between stakeholder groups or other issues that arise.
3. Pilot test these methodologies within organizations across the research ecosystem to see what works and what doesn't in meeting the needs and priorities of all stakeholders, and specifically address the issue of how to deeply embed an improved role for patients in drug development.
Problems addressed by Initiative
Originally, the initiative began with a "voice of the patient" perspective, since in initial discussions with patients it was clear that they felt they did not have a voice in the conduct of clinical research and drug development and there was very little understanding (or concern) on the part of the research ecosystem regarding what the patient disease and research journey entailed. However, as we progressed (and ACRES takes a systems approach to its initiatives), it also became clear that ignoring the concerns of any stakeholder would eventually doom patient centric approaches to becoming last year's fad.
As a result, the main focus of ACRES' patient engagement initiative is that of bringing transparency, cooperation, a sense of discovery and active implementation by all stakeholders regarding the optimal role of patients in the conduct of biomedical research, leading to the permanent embedding of patients as equal partners while resolving any constraints on this role that pose challenges to various stakeholders.