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Models of Engagement: Patients as Partners in Clinical Research

As patients take more active roles in decision-making about health, healthcare, clinical trials, and regulatory activities, their influence has changed how sponsors and researchers view patient involvement in clinical research. Once regarded as “subjects” who had research performed on them, patients are now contributing across the spectrum of clinical development, including in the design and planning of research protocols, selection of outcomes and endpoints, development of recruitment and retention strategies, and dissemination of research results. The unique perspectives afforded by patients’ lived experiences can inform researchers’ approaches and help identify knowledge gaps. By sharing their experiences of the daily burden of disease and their perspectives regarding unmet needs, therapeutic burdens, the balance of benefit and risk, and the types of research questions most important to them, patient partners can transform the clinical development process from one directed by sponsors and investigators to one driven by the needs of patients and their caregivers.

While the concept of patients as partners in clinical research is gaining momentum, recent research points to room for improvement. The development and validation of partnership models to engage patients in the design and governance of clinical research programs is still in its infancy, and approaches that can ensure meaningful and effective patient participation in research are needed. For this reason, the Duke Clinical Research Institute (DCRI) and their research partners are exploring models of patient engagement to determine what works best for patients, their caregivers, research sponsors, and investigators, with the ultimate goal of enhancing the speed and quality of clinical research.  The full article can be read here.



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