Advancing the Science of Patient Input
An increasing momentum for developing a science of patient input is connected to efforts to incorporate the patient perspective in the discovery, testing, and review of medical products. Robust patient input into these processes could provide a clearer picture of patient experiences with disease, and of their preferences and priorities for disease management and treatment. There is a pressing need to develop tools and methodologies to quantify and more systematically convert what has traditionally been anecdotal information solicited from patients into rigorous and credible evidence that can be used across the ecosystem. The science of patient input encompasses the development and use of systematic approaches and tools to collect, analyze, and apply robust and meaningful patient input to medical product discovery and development processes and regulatory decision making.
The Collaborative is an ad hoc activity convened under the auspices of the Forum on Drug Discovery, Development, and Translation (the Forum) at the National Academies of Sciences, Engineering, and Medicine (the National Academies). The work of the Collaborative does not necessarily represent the views of any one organization, the Collaborative, the Forum, or the National Academies and is not subjected to the review procedures of, nor is it a report or product of, the National Academies.
Many efforts have been launched to advance the science of patient input, and there is a critical need to take a system-wide pulse of the progress made in this area and identify progress-limiting gaps in the knowledge base that are hindering the field from collectively moving forward. Efforts to advance the science of patient input could be greatly enhanced and informed by a commonly held strategic research agenda and roadmap.
This Collaborative project will foster development of a strategic research agenda and roadmap by hosting discussions that will:
- Catalogue current efforts and progress in the science of patient input;
- Identify critical gaps in the knowledge base that are hindering progress;
- Prioritize among those knowledge gaps to develop a clear roadmap for research needs and progress.
Contribution to the Field
- Produce a broader and deeper understanding of knowledge gaps in the science of patient input, including the types of patient data, as well as the methodologies of collecting and analyzing patient input, needed to provide evidence that is objective, quantifiable, and standardized for use both within drug discovery and development programs and for regulatory approval.
- Inform development of a roadmap for addressing these knowledge gaps. This could include an end-to-end framework for incorporating patient input across the discovery and development of therapeutics.
- Promote better trials that engage patients and address their concerns, produce more relevant clinical data, have faster enrollment and lower costs, and support a better informed benefit–risk assessment.