ADAPTABLE Study Lauded As Top 10 Clinical Research Achievement

ADAPTABLE, the first demonstration project of PCORnet®, the National Patient-Centered Clinical Research Network, has been named by the Clinical Research Forum as a Top 10 Clinical Research Achievement Awardee for 2022. The awards celebrate outstanding achievements and major advances in clinical research from across the U.S. Honorees were selected by a panel that considered clinical research studies published in peer-reviewed journals in 2021, with specific attention given to innovation and novelty involved in the advancement of science.

The ADAPTABLE research team, including patient partners known as Adaptors, will formally accept the achievement award on April 19 at a ceremony in Chicago, IL. The team will then present at Translational Science 2022 and meet with members of the U.S. Congress to promote the importance of funding for clinical research.

A major achievement in pragmatic study design
ADAPTABLE, which sought to determine the safest and most effective dose of aspirin for patients with existing cardiovascular disease, broke ground as the first major randomized comparative effectiveness trial conducted using the broad and rich data resources of PCORnet. The trial’s novel strategies set a blueprint for the future of pragmatic study design by integrating research within patient care and using technology to effectively alleviate site and patient burden.

The infrastructure of PCORnet was central to ADAPTABLE’s successful execution. Via the Network, the study team leveraged electronic health records (EHRs) to identify potential participants, and then followed up with traditional outreach such as phone calls, letters, emails, and conversations in clinics. Data from PCORnet-accessible EHRs, patient-reported outcomes, insurance, and Medicare claims data were used to capture primary endpoints for the study where possible. Collecting data in this way minimized the need for in-person visits and thereby reduced participant burden.

At the heart of the study’s novel design were the Adaptors, who worked alongside researchers in all aspects of the trial, including helping to design the protocol, consent form, study portal, and study materials.

Ultimately, investigators found no significant difference in either protective effects or bleeding risk between the 81 mg and 325 mg doses of aspirin. However, the patients in the group taking the lower dose were less likely to switch doses mid-study or discontinue aspirin completely.

Publication of ADAPTABLE’s results in the New England Journal of Medicine was met with praise. An accompanying editorial penned by Colin Baigent, professor of epidemiology at the Nuffield department of population health at Oxford University and director of the Medical Research Council Population Health Research Unit, called the trial “a major achievement … because it has shown a method of conducting trials efficiently and at low cost in the United States, and this method can now be adapted and used more widely. This should allow many more clinical questions to be answered, with obvious benefits to health care consumers.”