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ADAPTABLE, the Aspirin Study – A Patient-Centered Trial

ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness)  is a three-year pragmatic clinical trial that will compare the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. Pragmatic trials are designed to reflect “real-world” medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care.

Duke Clinical Research Institute is the Coordinating Center for ADAPTABLE. Doctors Adrian Hernandez and Matthew Roe are the Co-Principal Investigators. The Operations Team is led by Holly Robertson, Lisa Berdan, and Tyrus Rorick.

ADAPTABLE is embracing a new paradigm of patient engagement in clinical research. The ADAPTABLE patient partners, Adaptors, work alongside researchers in all aspects of the trial, including designing the protocol, consent form, study portal, and study materials.

Former FDA Commissioner, Robert Califf, MD, describes research of interest to the Food and Drug Administration (FDA) and how ADAPTABLE serves as a model of evidence generation to answer critical, pragmatic questions quickly.

Protocol and Consent Available

Seeking input at every critical step, from consent design and protocol development through dissemination of final study results, ADAPTABLE represents a transformative approach to developing a new, efficient, and interactive clinical trial model. Unprecedented in the design of clinical trials, the final consent form and protocol were shaped with input from patients, local institutional review boards, physicians, and study coordinators.

Funding

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. More information about PCORnet can be found here.

The information and views presented on this website are solely the responsibility of the author(s) and do not necessarily represent the views of the other organizations participating in or collaborating with PCORnet® or of the Patient-Centered Outcomes Research Institute (PCORI). More information about PCORI can be found here.