Document Type
Dissertation
Date of Degree
6-25-2025
Primary Advisor
Andrew C. Meltzer
Keywords
Case study; Patient engagement; Clinical research; Integrating patient engagement into research
Abstract
Background: Patient engagement (PE) in clinical research has become “extensively and internationally recognized as important and gained growing policy attention, supported by scientific evidence” (Al-Tannir et al., 2017, Background section). The proliferation of PE directives has driven the paradigm shift in drug development from a paternalistic approach to a more patient-centric approach influenced by regulatory agencies, funders, and academic initiatives (Bombak & Hanson, 2017). However, too often, PE activities are not well considered for discovering actionable insights but are merely an empty formality. For PE to be meaningful, patient involvement must be planned, supported, and valued by clinical researchers.
Objectives: The aim of this study was to explore how researchers have incorporated PE activities into their clinical research. The central question was how significant researchers view PE and what opportunities and barriers they have encountered to incorporate meaningful PE activities into their research.
Methods: A collective case study involved professional clinical researchers from academic institutions and industry. Purposive sampling from professional networks and public research sites identified participants integrating PE activities into their research. Data were collected from one-on-one semistructured interviews after informed consent review. Interviews were recorded via Zoom, and data were uploaded to ATLAS.ti for transcription, then to NVivo for coding and thematic identification. This study was exempted by the George Washington University Institutional Review Board.
Results: Thirteen participants consented to semistructured interviews, with research experience spanning from under 10 to over 20 years. Four participants (38.8%) had 0−10 years, five (38.5%) had 11−15 years, two (15.4%) had 16−20 years, and two (15.4%) had more than 20 years. Participants were geographically diverse, residing in the Southwest (n = 1, 7.7%), Southeast (n = 2, 15.4%), New England (n = 2, 15.4%), Northwest (n = 5, 38.5%), North Central (n = 1, 7.7%), and Midwest (n = 2, 15.4%). Although offering varied definitions, most aligned with the U.S. Food and Drug Administration’s (2022) definition of “intentional, meaningful interactions with patients that provide opportunities for mutual learning and effective collaborations” (para. 3). PE was commonly described as, actively centering the patient’s voice in research. Some participants mentioned conducting research without patient input but acknowledged the importance of patient involvement in enhancing study design, recruitment, diversity, community engagement, and dissemination activities. Barriers included financial constraints, lack of knowledge and training, superficial views of PE, and insufficient regulatory guidance.
Conclusion: Despite PE’s recognized importance, the findings underscored the challenges and opportunities in integrating it into research activities. Participants acknowledged the advantages of PE; and stressed the need for organizational and systemic reforms to improve current conditions, funding methods, and regulatory guidance. Sustainable engagement strategies—such as regulatory support, financial assistance, best practice training, and institutional commitment—are essential for transforming PE from a beneficial approach to a best practice. Addressing these challenges and providing training and clear regulatory guidance will ensure PE is central to high-quality, patient-centered research, ultimately enhancing patient lives and outcomes.
Recommended Citation
Richards, Lorna M., "A Collective Case Study of How Researchers Describe Their Experiences, Challenges, and Perceived Impact of Patient Engagement" (2025). Doctor of Philosophy in Translational Health Sciences Dissertations. Paper 41.
https://hsrc.himmelfarb.gwu.edu/smhs_crl_dissertations/41
Open Access
1
Comments
©2025 by Lorna M. Richards. All rights reserved.