By Allison Proffitt 

November 4, 2024 | BARCELONA—A profound shift is underway: one that positions patients not merely as recipients of clinical care but as active participants and collaborators in clinical research. A panel at last week’s SCOPE Summit Europe took on this challenge.  

Paul Duffy, head of global clinical site partnerships at MSD, led the discussion. His panelists were Bari Kowal, senior VP and head of global clinical operations at Regeneron; Maria Dutarte, executive director of the European Patients’ Academy on Therapeutic Innovation (EUPATI);  and Maria Koutsopoulou, senior VP at Merck KGaA.  

We are certainly not yet at a convergence point of clinical care with clinical research. Koutsopoulou, a passionate advocate for patient involvement in clinical trials, reflected on her family’s struggles with cancer. “The implications we faced in accessing innovative medicine are unfortunately unchanged,” she noted, comparing her father’s battle with cancer decades ago to a more recent loss in her family. Her experiences fuel her dedication to improving clinical care and research, underscoring the importance of involving patients in every step of the process. 

Dutarte’s work at the European Patients’ Academy on Therapeutic Innovation (EUPATI) is focused on educating and empowering patients to partner effectively in the medicines development process. EUPATI, an educational initiative launched by the European Commission, features a free online toolbox available in 14 languages, aimed at demystifying clinical trials and fostering a deeper understanding of patient roles. 

Since its inception, EUPATI has reached nearly 8 million users globally, with over 400 patient experts graduating from a comprehensive training program, Dutarte said. These graduates not only engage in clinical research but also serve as mentors, raising awareness and empowering others within their communities. “This creates a ripple effect, enhancing patient literacy and engagement in clinical research,” she explained. 

Kowal highlighted TransCelerate’s efforts to improve the patient experience. Asking the right questions is key, she said. For example, when a study calls for digital biomarkers gathered from a device, are we sure the device is really comfortable for patients? Are the in-clinic procedures we ask them to undergo reasonable and manageable? How much time are we asking them to spend at the clinic? By prioritizing patient comfort and feedback, clinical trials can become more accessible and engaging. 

“At the end of the day, if the patient can’t withstand the trial, or if they don’t have good feedback to engage other patients, or really isn’t enamored by the process, that’s a struggle,” Kowal said.    

Part of the trick will be collaboration among stakeholders in the healthcare industry. The panelists emphasized that aligning goals and simplifying study designs could significantly improve patient recruitment and retention in clinical trials and Koutsopoulou noted that collaboration around study design is not as taboo as many may think. “We often find that the majority of challenges we face are common across the industry,” she noted. “If we collaborate to streamline processes and enhance communication, we can better serve patient needs.” Echoing Kowal, Koutsopoulou urged sponsors to focus on asking the right questions—and only the right questions—so that the data we gather are meaningful and useful.  

Duffy challenged the panel to outline steps the industry could take to speed up this vision of converged clinical research and clinical care. Dutarte highlighted the importance of creating a learning health system that integrates knowledge generation with practical application will be crucial in shaping the future of personalized medicine. 

Kowal emphasized the importance of patients sharing their data. “And one of the things that we're working on at Regeneron is a lot of personalized medicine, so a lot of genetics and looking at the genome. Being able to combine genomic data with physiological data, imaging data, lab data, all of this data, is the next frontier of clinical care,” she said. “Being able to use clinical research as an option for clinical care has to be something offered to every patient.” 

Koutsopoulou reminded attendees to keep the human touch even as we integrate new technologies. “Make sure that what we’re asking of patients is actually reasonable,” she said.  

Finally, Duffy challenged his panel to set the metrics for success, flagging what milestone—for them—indicates major momentum in the journey to converge clinical care and research.  

Progress will be clear, when converged health and clinical care, “increases access and diversity”, Kowal said. Dutarte envisions “a patient-centered healthcare system, where patients are not just passive receivers of care, but also actively contributing.” And Koutsopoulou looks forward to a day when “investigational medicines are presented to patients at the same time as approved treatments.”