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Accepted for/Published in: Journal of Participatory Medicine

Date Submitted: Mar 24, 2025
Open Peer Review Period: Dec 15, 2025 - Feb 15, 2026
Date Accepted: Nov 17, 2025
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Advancing the Science of Patient Input in Drug Research and Development

Metcalf MA, Cavagnini KS, Awo Osei-Anto H, Patrick-Lake B, Sharp TJ, Shore C, Clark LT

Advancing the Science of Patient Input in Drug Research and Development

J Particip Med 2026;18:e74436

DOI: 10.2196/74436

PMID: 42066297

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Advancing the Science of Patient Input in Medical Product Research and Development

  • Marilyn A Metcalf; 
  • Kyle S Cavagnini; 
  • Henrietta Awo Osei-Anto; 
  • Bray Patrick-Lake; 
  • Thomas J Sharp; 
  • Carolyn Shore; 
  • Luther T Clark

ABSTRACT

Patient-centered medical product research & development (R&D) enables researchers and medical product developers to more effectively and efficiently discover and develop new therapeutic interventions that meet the needs of patients. While there is growing momentum to incorporate evidence-based patient input into decision-making processes throughout the medical product R&D life cycle, there remain a host of barriers to full implementation and integration of systematic approaches for collecting and using robust and meaningful patient input data, including lack of tools, methodologies, and parameters for soliciting and incorporating different types of patient input. This article lays out three overarching research priorities that, if effectively addressed, would help advance the science of patient input: 1) understanding the patient experience over the course of a given disease or medical condition, 2) capturing the patient perspectives and priorities on benefit-risk, and 3) incorporating patient input into clinical trial design and continuous improvement. Approaches to address each of these research priorities can better enable the incorporation of patient input throughout the medical R&D life cycle to inform decision-making on the part of researchers, medical product developers, regulators, clinicians, and patients.


 Citation

Please cite as:

Metcalf MA, Cavagnini KS, Awo Osei-Anto H, Patrick-Lake B, Sharp TJ, Shore C, Clark LT

Advancing the Science of Patient Input in Drug Research and Development

J Particip Med 2026;18:e74436

DOI: 10.2196/74436

PMID: 42066297

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