Orlando, Fla. — From comic books for kids in pediatric trials to including patients in protocol design, this year’s SCOPE conference revealed a fresh commitment to making trials more patient-centric.
At TESARO, executives see several areas where patient centricity can improve trial speed and efficiency: ensuring that the protocol is simple to administer for the patient; enhancing convenience so the patient stays in the study; using the patient community to identify the most important unmet need and building patient ownership and commitment to the trial.
TESARO provides patients with a single-page study summary of their trials, a list of what to expect at each study visit, information on advocacy organizations, support materials for caregivers and regular updates about why the study is being done, said Beth Zaharoff, senior director for patient focused engagement and partnerships at the company.
Melanie Goodman, Pfizer’s director of patient recruitment programs, reminded her audience that you can’t “kind of do” patient-centric trials: Every aspect, from the protocol to the site, has to think about ways to make trials both easier and better for the patients who enroll in them. Even a small change in how a patient profile is filtered through the different points of contact can dramatically alter a trial’s strategy, Goodman said.
“Every patient in clinical trials deserves health-literate information,” said Laurie Myers, global health literacy director at Merck. If patients don’t know what an SAE is “they can’t report it.”
Just as SCOPE was wrapping up, CTTI issued new recommendations for ways that mobile trial sponsors can use technology to make trials easier for patients. CTTI urges sponsors to bring patients in as early as possible in mobile trial design through advisory panels, surveys and focus groups.
Jonathan Jackson, director of the CARE Research Center at Massachusetts General Hospital, has spent much of his career working on ways to improve trial enrollment — especially minority trial enrollment.
Like many trial professionals, Jackson is optimistic about the industry’s mobile future.
“We may finally be able to overcome transportation and location barriers to clinical trial participation, one of the biggest factors holding us back in creating a sustainable research enterprise,” he says.
All true, CTTI acknowledges, but sponsors, sites and investigators should take a deep breath when they’re considering mobile tech because they “may actually increase participant burden if risk, needs and expectations are not considered and addressed during the study planning process.”
Back at SCOPE, Andrea-Berki-Nnuji, Praxis Communications’ director of analytics, and Robert Loll, Praxis’ senior vice president for strategic planning, said that today’s technology offers “social listening” — really trying to understand the feelings patients are experiencing.
If trial professionals can’t identify their patients’ needs, they’ll have to do more research, Berki-Nnuji and Loll argued. Again, sponsors and CROs should ask themselves what kind of strategy they want to pursue: quantitative research (patient populations, surveys, etc.) or qualitative research (through in-depth interviews or focus groups).
At Eli Lilly, executives have developed a patient experience matrix to ensure clarity and engagement. “Participants appreciate the microsites we develop and they appreciate the support materials we develop,” said Amy McCormick, innovation lead, patient experience and design innovation at Eli Lilly. Our goal is to “help patients demystify trials.”