Incorporating Patient Preferences in Clinical Trial Design and Research
This whitepaper was authored by Margaret Sheehan and Anne Cohn Donnelly, who live with Parkinson’s disease and have participated as Patient Scientists on the MDIC PCOR project team along with representatives from the Michael J. Fox Foundation for Parkinson’s Research (MJFF), the FDA, and MIT. In this paper, the authors provide guideposts for how clinical trial sponsors can effectively engage patients as partners throughout the clinical trial process, providing the clinical research and medical product community with their insightful and impactful recommendations and underscoring the importance of including the patient voice early and often throughout the medical product development process. Patients will be interested in the paper’s review of best practices for engaging patients early and often within medical device development process, and they may find it useful to compare their own experiences with those of the authors.
In 2020, MDIC released this whitepaper authored by Margaret Sheehan and Anne Cohn Donnelly, who live with Parkinson’s disease and have participated as Patient Scientists on the MDIC PCOR project team along with representatives from the Michael J. Fox Foundation for Parkinson’s Research (MJFF), the FDA, and MIT. This paper draws on the authors’ experience in those roles, as well as the extant literature, to address key questions of patient engagement in clinical research, including: Should patients have a voice in the design and interpretation of clinical trials? If so, how big a voice? In what ways should researchers include that voice? Where can patients be helpful? Where are patients essential? Should patients be treated as equal partners in research? What would constitute best practices for involving patients? Why should companies and other funders of clinical research invest the time and money in partnering with patients?
In this paper, the authors outline the many important reasons for including patients in the medical device development process as patients can offer a perspective not replicable in a research environment because they are living with the medical condition being studied. In this way, patients can help bring the clinical definition of a disease to life, humanizing the condition, the research focus, and the impact of any conclusions.
The authors review a series of “best practice” elements for engaging patient as partners in research, including how to include patients in the research process, where to find the patients that can be engaged in these efforts, when to engage patients, and what their roles can be. They also describe benefits to sponsors from doing this work and point out challenges that may arise along the way.