A novel approach to clinical research that encourages patient engagement is being rolled out at hospitals across the United States to compare the effectiveness of 2 common aspirin doses among patients with cardiovascular disease (CVD) who work as partners alongside researchers in all aspects of the trial.
The Aspirin Dosing: A Patient-Centric Trial Assessment Benefits and Long-Term Effectiveness (ADAPTABLE) study is a pragmatic clinical trial comparing 2 common aspirin doses—81 and 325 mg—among patients with CVD. Approximately 3,000 US patients with CVD were enrolled during its first year. The goal is to enroll thousands of patients over approximately 3 years.
The ADAPTABLE trial is being coordinated by the Duke Clinical Research Institute and involves physicians, clinician investigators, and patients at 8 partner research networks associated with the Patient-Centered Outcomes Research Institute (PCORI), an organization whose mission is to fund patient-engaged research. ADAPTABLE is the first intervention trial launched by PCORI.
Recruitment, engagement, and informed consent efforts focus on patients with CVD recruited from medical practices within the partner research networks. The patients primarily are recruited via e-mail, letters, or phone calls and are directed to a patient web portal to register online to participate in ADAPTABLE. This mechanism for recruiting and randomizing patients into a clinical trial has never been used before on such a large scale.
Duke cardiologist, Matthew Roe, MD, MHS, one of 2 co–principal investigators for ADAPTABLE, says patient participation promotes engagement and allows researchers to involve more patients at a lower cost than existing clinical trials.
“This is the future of clinical research,” Roe says. “We share everything we do on the ADAPTABLE website with the clinical research community. It’s an exciting and promising model.” He says he hopes this trial will prompt more researchers to adopt these new, streamlined research methods because this approach is “far less complicated and more far reaching” than traditional clinical research methods.
Institutional Review Boards have become more flexible about this streamlined research approach after initial reluctance, Roe says. “Like anything new, this has taken some time to be accepted.”
National medical journals have taken notice as well. The ADAPTABLE study was cited in the New England Journal of Medicine in a multipart review article published March 2, 2017, as an example of a novel approach to informed consent and internet-based clinical trials. The simple participation options reflect a growing interest in freeing informed consent from the constraints of physical clinical sites. Recruitment can expand from limited catchment areas to reach many more eligible patients through web-based channels.
Participant enthusiasm is evident in patient communications about the trial via internet forums and social media. Several patient partners have participated in live-streamed, Facebook broadcasts.
To learn more about the study, visit The Aspirin Study website.