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Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda - A Workshop

Completed

This public workshop provided a venue for stakeholders to examine gaps in knowledge and other barriers that hinder the advancement of a science of patient input (SPI) in medical product research and development (R&D), with consideration of downstream regulatory and post-market decision-making. Subject matter experts representing a range of disciplines examined the state of SPI, explored gaps in the knowledge base and other barriers impeding progress, and discussed potential components of a research agenda for addressing gaps or barriers to realizing a science of patient input.

Please visit our event page for additional information and meeting materials for the workshop.

Description

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will plan and conduct a one-day workshop focused on the science of patient input in medical product research and development (R&D), with consideration of downstream regulatory and post-market decision-making. At this workshop, subject matter experts representing a range of disciplines will engage in presentations and discussions to:
Examine the state of the science of patient input, including successes and limitations of current efforts.
Explore gaps in the knowledge base and other barriers that impede progress, including but not limited to:

  • Parameters for soliciting and incorporating different types of patient input along the spectrum of medical product R&D;
  • availability, accessibility, and applicability of data sources for patient input;
  • tools and methodologies for collecting and analyzing patient input to produce scientifically rigorous, credible evidence; and
  • understanding of the ethical and value considerations for soliciting and incorporating patient input into medical product R&D decision-making.

Discuss a potential framework for and components of a research agenda for addressing gaps or barriers to realizing a science of patient input.
The committee will develop the agenda for the workshop, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A brief proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

Contributors

Committee

Co-Chair

Co-Chair

Member

Member

Member

Member

Member

Member

Member

Member

Member

Member

Member

Member

Sponsors

Department of Health and Human Services

Private: For Profit

Private: Non Profit

Staff

Carolyn Shore

Lead

Rebecca English

Melvin Joppy

Amanda Wagner Gee

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