The pragmatic clinical trial was the first demonstration project of PCORnet®, the Patient-Centered Clinical Research Network, which is an integrated partnership of clinical research networks funded by the Patient-Centered Outcomes Research Institute (PCORI).
The Clinical Research (CR) Forum, a nonprofit organization dedicated to promoting understanding and support for clinical research and its impact on health and health care, has selected the ADAPTABLE study as a Top 10 Clinical Research Achievement Awardee for 2022. The awards recognize outstanding achievements in clinical research from across the U.S., identifying major advances in the biomedical field resulting from the nation’s investment in health and welfare.
The CR Forum will honor the ADAPTABLE research team, led by DCRI investigators, 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 pragmatic, open-label, patient-centered, randomized clinical trial, ADAPTABLE sought to determine the safest and most effective dose of aspirin for patients with existing cardiovascular disease. Despite aspirin being used as a secondary prevention method for nearly three decades, this question had not been studied previously.
Beginning in 2016, ADAPTABLE randomized 15,076 people with existing cardiovascular disease to receive either baby aspirin (81 mg) or regular strength aspirin (325 mg). Ultimately, investigators found no significant difference in either protective effects or bleeding risk between the two doses. However, the patients in the group taking the lower dose were less likely to switch doses mid-study; furthermore, that group’s patients were slightly less likely to discontinue aspirin completely.
This year’s Top 10 Clinical Research Achievement Awards recognize groundbreaking clinical research studies published in peer-reviewed journals in 2021. Thus, the CR Forum will present this award to Schuyler Jones, MD, ADAPTABLE’s principal investigator and the lead author of the results paper, which was simultaneously published in the New England Journal of Medicine and presented at the 70th annual American College of Cardiology Scientific Session & Expo:
Jones, W. S., Mulder, H., Wruck, L. M., Pencina, M. J., Kripalani, S., Muñoz, D., Crenshaw, D. L., Effron, M. B., Re, R. N., Gupta, K., Anderson, R. D., Pepine, C. J., Handberg, E. M., Manning, B. R., Jain, S. K., Girotra, S., Riley, D., DeWalt, D. A., Whittle, J., Goldberg, Y. H., … ADAPTABLE Team (2021). Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease. The New England journal of medicine, 384(21), 1981–1990. https://doi.org/10.1056/NEJMoa2102137
DCRI investigators designed ADAPTABLE to mirror routine health care as closely as possible to help support real-world decisions made in clinical care. The study team published a design paper in March 2020 in JAMA Cardiology, in which they detailed how using pragmatic elements—such as integrating research within patient care and leveraging technology—helped to alleviate burden on patients and site staff.
ADAPTABLE was the first interventional trial conducted within the electronic data infrastructure of PCORnet, a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the U.S., in order to test unique and innovative operational approaches. ADAPTABLE’s funding came from the Patient-Centered Outcomes Research Institute (PCORI), an independent nonprofit, nongovernmental organization in Washington, DC.
In addition to Jones, DCRI contributors to ADAPTABLE include Adrian Hernandez, MD, MHS; Lesley Curtis, PhD; Brad Hammill, DrPH; Debra Harris; Laura Qualls, MS; Hillary Mulder, MS; Lisa Wruck, PhD, MSPH; Michael Pencina, PhD; and Patty McAdams. Former DCRI contributors include Matthew Roe, MD; Lisa Berdan, PA, MHS; Guillaume Marquis-Gravel, MD, MSc; Holly Robertson, PhD, PMP; and Amber Sharlow, MBA, CCRA.
The Top 10 award recipients are selected by a CR Forum panel from among clinical research studies published in peer-reviewed journals in 2021. They are based on the degree of innovation and novelty involved in the advancement of science; contribution to the understanding of human disease and/or physiology; and potential impact upon the diagnosis, prevention, and/or treatment of disease.