IHI and IMI have had a long-standing history of encouraging meaningful patient participation in health research projects. In particular, one IMI1 project, EUPATI, focused on delivering patient education, so that patients could be more impactful when contributing to research. The goal was to bridge the gap between researchers and patients, so that both communities were speaking the same language.
The project closed nine years ago – and now, EUPATI has become a stand-alone non-profit organisation which continues to deliver trainings and facilitate patient involvement in research. It has now been a partner in several subsequent IHI and IMI projects, including READI, FACILITATE and COMBINE-CT to name a few. And over the past six years, the landscape has changed – patient involvement in research has grown significantly, and today more patients than ever bring strong expertise, awareness and motivation to take part in research.
Now, says EUPATI executive director Maria Dutarte, the focus has broadened – alongside training patients about research, there is now an equal priority on training researchers on how to more meaningfully engage with patients. In the GREG project, which is focused on real-world evidence, a systematic plan including patients in every work package was developed from the outset – during the application phase.
Amongst patients, interest in real-world data projects is high. GREG received close to 70 applications for its patient advisory group, seven times the number of places.
“It’s a natural fit because many patient organisations have worked on patient-led registries for instance for many years. It wasn’t necessarily called real-world data at that point though,” says Dutarte.
But looking through the literature, EUPATI found that the majority of real-world data peer-reviewed publications published to date have not consulted patients. “One particular rapid review conducted a wide search of real-world data research, but found only a handful of studies that clearly reported patient involvement” says Dutarte. “We saw a real gap there. These studies were being developed without any input from the patient groups that were being affected.”
A systematic approach
GREG took a carefully planned approach to patient involvement. It started with a survey, sent to the GREG researchers, to evaluate their experiences and the appetite for patient involvement. Dutarte recalls that they received an enthusiastic response to the survey, with many researchers expressing their desire to engage with patients. What was missing was a road map on how to effectively do that. The researchers emphasised that concrete actions and examples of practical implementation were needed.
EUPATI, together with some of the partners, then took that information and used it to inform a two-part workshop series. Starting with an online session and then an in-person session, the trainers (members of EUPATI Faculty) covered standards, best practices, guidelines, patient experiences and more.
By the end of both sessions, the team had identified key performance indicators for meaningful patient involvement that could be evaluated throughout the project. In particular, GREG decided to track evidence of early and continuous patient involvement across work packages, to count the number of outputs or decisions influenced by patient input, to quantify the evidence that the patients changed or improved outputs, and also to regularly check that plain language was being used in patient-facing materials.
In addition, members of the patient advisory group had been assigned to different work packages, and Dutarte noted that after the training workshops, she began to see conversations starting up between researchers and patients.
“There is a dialogue that is forming between the researchers and the patient representatives,” she says. “During the workshops, the scientists were invited to explain their work in lay terms, so that the patients could bring their own point of view.”
One lesson learned was that setting up a patient advisory group and expecting things to flow organically is not realistic.
“It needs to be accompanied by training efforts,” says Dutarte, emphasising that the GREG researchers were enthusiastic about patient involvement but didn’t always know where to start.
Another important way that GREG evens the playing field between patients and researchers is by reimbursing patients for their time spent in consortium meetings or on GREG activities. This is a provision that needs to be factored into the project budget during the application phase. If not set out in the initial budget, patients are often expected to contribute voluntarily and are not paid for their time. Dutarte highlights how not paying for patients’ expertise immediately puts them on a different footing compared to the researchers. She says that patients often have to contribute around their own working days, and that they do not have the same resources as researchers, therefore at a minimum their time should be compensated.
“It can be questioned, why is everyone else covered but not the patients. It sends a signal in the wrong direction,” she says.
Avoiding tokenism
A key point that EUPATI emphasises throughout its training programmes is that patient participation should be well-thought-through and properly considered.
“Patient experiences are so rich, and so diverse. If you are, for example, inviting a patient to speak on a panel, it shouldn't be about finding just any patient to fill the seat, you have to think about their specific experience and how they will contribute and deliver value,” says Dutarte.
“You also have to think about the role that you are giving to that patient. Is it to lead that conversation? Are they part of co-creating the session? Can they be part of making decisions on what the questions should be?”
Strong leadership that values a co-design thinking approach is also critical to have meaningful patient contributions to a project.
“Leadership needs to be thinking, what are the outcomes of the project? Is the patient perspective integrated from the start so that it is not an afterthought? Are there unmet needs that could be addressed?” says Dutarte. She adds that sometimes, innovators can be keen to pursue a certain technology that is no longer wanted or needed by the patient community.
GREG is just entering its second year, so it’s early to say whether the systematic approach will have the desired impact. But Dutarte is hopeful and says it’s a strong start. In May 2027, the plan is to have a second workshop to take a look at the KPIs and see how the project is progressing.
How can applicants integrate patient perspectives meaningfully into a project proposal?
For potential applicants who want to take this approach and include patients in an impactful way, Dutarte says that finding the right patient partners is very important and that engaging patients into the project proposal process at the earliest stage is essential.
“If the entire proposal has been written without getting the patient perspective, then that’s a lost opportunity,” she says. “We can do much more from the early phases and put some things upside down. In regards to the application, we must demonstrate how the project will benefit patients. That must be the starting point.”
EUPATI was supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry; whereas GREG is funded by the Innovative Health Initiative.