ADAPTABLE, the first large, pragmatic clinical trial to be coordinated at the Duke Clinical Research Institute, DCRI, recently celebrated a milestone as the trial reached its goal of enrolling 15,000 patients.
Many individuals living with heart disease are instructed to take aspirin to prevent heart attacks and strokes. However, aspirin can cause bleeding in some individuals, and there is no data available that can help physicians decide on the optimal dose to prescribe. ADAPTABLE will compare two different doses—a high dose of 325 mg and a low dose of 81 mg—to determine which is more safe and effective.
Using Real World Data from EHRs
ADAPTABLE, which is funded by the Patient-Centered Outcomes Research Institute (PCORI), is a pragmatic clinical trial, meaning that research is integrated in patient care and leverages technology to alleviate burden on patients and site staff. ADAPTABLE is a demonstration project of PCORnet, the National Patient-Centered Clinical Research network. Forty healthcare systems and three health plans are participating in ADAPTABLE.
ADAPTABLE draws data from electronic health records (EHRs), patient-reported outcomes, and insurance claims data to capture primary endpoints.
“ADAPTABLE is a ground-breaking clinical trial for several reasons, including primarily remote recruitment of patients outside of traditional research clinic settings, direct-to-patient follow-up, and surveillance of EHRs to identify patients for potential enrollment and to ascertain potential endpoints during follow-up,” said Matthew T. Roe, MD, MHS, co-principal investigator for ADAPTABLE. “Via a web-based platform, we conduct outreach to potentially eligible patients to ask them if they’re willing to provide informed consent via an electronic, web-based consent module, which then allows patients to self-randomize into the study. These approaches have never been used before for a large-scale clinical trial the size of ADAPTABLE.”
Viewing Patients as Partners
ADAPTABLE provides a new model of engaging with patients. Patient partners also known Adaptors represent the patient voice at every stage of the study by providing input on study recruitment, contributing to participant newsletters, participating in working groups, and presenting on ADAPTABLE at scientific meetings.
Incorporating a group like the Adaptors is reflective of DCRI’s mission to engage all stakeholders with the goal of improving the study participant experience in clinical research. Get to know and learn more about the Adaptors.
“Patients themselves may be the most important and yet underutilized voice in research,” said Adaptor Greg Merritt, of Ann Arbor, Michigan. “The ADAPTABLE Study is a wonderful example of how patients can assist researchers in prioritizing and studying what matters most to a patient who lives with an illness or disease every day. Their insight and perspective can help to uncover new ways to look at old problems.”
Learning Logistics through a Pragmatic Approach
The ADAPTABLE team—researchers, clinicians, and patients alike—has learned many lessons through the enrollment period of the first large pragmatic clinical trial conducted at the DCRI.
First and foremost, the researchers learned that collaboration between diverse organizations is critical in reaching a goal as large as 15,000 participants.
“Using novel tools and techniques, we are transforming how patients are identified and recruited for clinical trials,” Holly Robertson, PhD, project leader for ADAPTABLE, said. “We also developed strategies for clinician and patient engagement which are important in supporting recruitment and retention for virtual trials.”
The study team also shared that when recruiting patients, it is beneficial to contact potential participants through multiple modes of communication: online, by phone, through the mail, and in person.
“The ADAPTABLE study has encouraged increased collaboration and inspired us to work together to solve new interesting research challenges using a pragmatic approach,” said Schuyler Jones, MD, co-investigator for ADAPTABLE.
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