Dr. Adrian Hernandez, director of Health Services and Outcomes Research at Duke Clinical Research Institute (DCRI) and Madelaine Faulkner, Health-eHeart Alliance Project director, recently hosted a sunrise session on the value of patient-centricity in clinical research at the inaugural American Heart Association (AHA) Research Academy conference. Using ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) as an illustration, Hernandez and Faulkner offered the conference’s nearly 300 attendees tips for breaking down the language barrier that often exists between patients and physicians and giving patients a voice in the clinical research process.
“The inaugural AHA Research Academy conference was a fantastic opportunity to network and share insights with some of the most prominent thought leaders in cardio- and cerebrovascular disease,” said Hernandez. “Our work to drive patient-centricity with ADAPTABLE was well received by the conference attendees, which underscores our goal at PCORnet, the National Patient-Centered Clinical Research Network, to transform the culture of clinical research from one directed by researchers to one driven by the needs of patients and those who care for them.”
ADAPTABLE is funded through a research award totaling up to $18 million from the Patient-Centered Outcomes Research Institute (PCORI). DCRI is the Coordinating Center for this first clinical research study of PCORnet, an innovative initiative of PCORI involving 33 individual networks working together to make it faster, easier, and less costly to conduct clinical research by harnessing the power of large amounts of health data and patient partnerships. The study plans to enroll 20,000 patients with heart disease identified from electronic health records from eight of PCORnet’s Clinical Data Research Networks (CDRNs) and 30 different health systems. The Health eHeart Alliance Patient-Powered Research Network (PPRN) supports the Adaptors, a team of people with coronary heart disease who helped design the protocol, consent form, portal content, and study materials. Together the Adaptors and Health eHeart Alliance have developed patient-centered processes to facilitate engagement and provide the patient perspective that is so often missing in the clinical research process.
While Hernandez opened the session with an overview of patient centricity’s value, it was Faulkner’s presentation that examined the nuts and bolts of how ADAPTABLE is bringing patient-centered research to life.
“The input from Adaptors helps us to break down the language barrier that often exists between patients and physicians,” said Faulkner. “We get feedback that we cannot speak in acronyms all the time and that we need to make research approachable to communicate its value. When we break down these communication barriers, we deepen our engagement with our patient leaders — and hopefully this will transfer to the broader patient population as well.”
In addition to the perspectives brought by Hernandez and Faulkner, Jamie Roberts of the Clinical Trials Transformation Initiative (CTTI), a Duke/FDA public-private partnership, described CTTI’s published Best Practices for Patient Group Engagement and how the CTTI project team is now working to understand and demonstrate the value of patient group engagement to industry and academic research sponsors.
Overall, the AHA Research Academy was a positive and insightful meeting that provided not only a venue to showcase ADAPTABLE’s innovative patient-centric approach, but also a learning opportunity to glean insights from the academic community.
“I saw a number of thought-provoking presentations, including one with an excellent quote by an information technology health strategist named Leonard Kish,” said Hernandez. “Kish said, ‘If patient engagement were a drug, it would be the blockbuster drug of the century and malpractice not to use it.’ I wholeheartedly agree and am proud that PCORnet is pioneering patient-centric research with the ADAPTABLE study.”
The ADAPTABLE study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (Contract Number: ASP-1502-27079). ADAPTABLE is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is a PCORI-funded initiative designed to improve the nation’s capacity to conduct comparative clinical effectiveness research.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information is available at www.pcornet.org.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.