There is growing momentum to incorporate patient input into medical product research and development (R&D) and regulatory decision-making. However, much of this input remains anecdotal and inconsistently applied. Strengthening the science behind patient input so that it can be translated into rigorous, credible evidence can help ensure that medical product development better reflects patient experiences, needs, and preferences.

Significant process has been made in recent years. Still, broader adoption across the R&D life cycle has been limited by research gaps, siloed efforts, and a lack of clear metrics to demonstrate impact.

Objectives

The Advancing the Science of Patient Input in Medical R&D Action Collaborative (the collaborative), an ad hoc activity associated with the National Academies Forum on Drug Discovery, Development, and Translation, aimed to lay the groundwork for a coordinated research agenda by hosting discussions to:

• Catalog the current state of the science of patient input, including successes and limitations of current efforts for its application in medical product R&D.
• Highlight the types of patient input, as well as the tools and methodologies for collecting and analyzing this information, needed to provide evidence that is useful across the spectrum of medical product R&D and regulatory decision-making.
• Lay the foundation for a research agenda for addressing knowledge gaps and other barriers impeding progress in the field.
• Better align medical product discovery, development, and regulation with patient preferences for disease management and treatment.

Collaborative Activities

Building on a 2018 workshop hosted by the Forum on Drug Discovery, Development, and Translation, the collaborative brought together a group of diverse stakeholders for a series of discussions focused on pre-market medical product R&D. Key topics included:

• Understanding the patient experience with a disease or medical condition
• Capturing patient perspectives and preferences on benefit-risk
• Incorporating patient input in clinical trial development and continuous improvement

Select participants co-authored a perspective article in the Journal of Participatory Medicine, highlighting ongoing challenges and practical approaches to support more systematic and meaningful use of patient input in decision-making.

The collaborative, which sunsetted May 2026, was an ad hoc activity associated with 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 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.