What happens to the quality of a clinical study when the target of that study, the patient plays a role in its design?
Crazy, right? A group of five osteoarthritis (OA) patients from Norway, The Netherlands and UK decided to band together for the express purpose of helping investigators improve the experience of study participants.
Here is what happened next.
The patients formed the Patient Council and brought their perspectives to a study named APPROACH (which stands for Applied Public-Private Research enabling Osteo Arthritis Clinical Headway).
APPROACH is, in fact, an international and cross-discipline collaboration project between multidisciplinary team from clinical centers, research institutes, and corporations and, of course, these patients. The APPROACH project is currently underway in France, The Netherlands, Norway, and Spain, with research partners in Austria, Belgium, Denmark, Finland, Germany, Sweden and the UK.
The goal of APPROACH is to improve OA trial design by way of more targeted trial inclusion criteria or the use of more specific and sensitive outcome parameters that define the progression of OA.
The study, “Making the patient voice heard in a research consortium: experiences from an EU project: (IMI-APPROACH),” appears in the May 10,2021 edition of BMC: Research Involvement and Engagement.
Co-author Irene Kanter-Schlifke, Ph.D. told OTW, “We decided to involve people living with osteoarthritis at the beginning of this project. Both the funder of the project, the research partners and the patient organizations involved all appreciated from the start that a Patient Council should accompany the project to ensure the continued alignment of the research with real world patient needs. Having learned a lot of important lessons throughout the project, the Patient Council was eager to share their experiences by way of this article. Their goal is that researchers and patients alike are encouraged to get involved with each other in all future research.”
The Patient Council evolved during the project from individuals who didn’t know each other, nor the research partners, to a team that truly integrated with the project and served as partners and advisors to the researchers.”
“The assumption is, and this is what feedback from research partners indicated,” said Dr. Kanter-Schlifke, “that involving people living with osteoarthritis in this research makes the outcomes ultimately more relevant and makes the experience of the clinical trial smoother for trial participants. This in turn can have impact on drop-out rates and possibly encourage people to participate in future clinical trials.”
The authors wrote: “The presence of patients also changes the way researchers talk to each other—having to think about and talk about their research in lay terms encourages more self-reflection on ‘what,’ ‘why’ and ‘how’ of what they are doing. This also encourages more discussion across areas and subject disciplines from other researchers in the room. This can lead to a subtle change in the dynamics in the room and make all discussions more inclusive.”
As one of the researchers from the UK stated, “The questions asked by the patient council are sometimes very surprising, something that researchers have not thought of before. It opens new roads for the design of new studies.”
And the program manager from The Netherlands said, “In large complex clinical studies, in which multiple partner organizations are involved, we tend to forget that our joint effort is not just scientific research or getting a new drug on the market, but it is finding actual medical solutions ‘for patients with patients’. The work of the Patient Council constantly reminds us of this goal.”
