Elements from ADAPTABLE could be implemented in future trials to make them more efficient, the paper’s authors write.
A paper recently published in JAMA Cardiology details the design of ADAPTABLE, a DCRI-led pragmatic clinical trial that uses many novel elements to efficiently answer a question that has substantial impacts on public health.
ADAPTABLE seeks to determine the optimal dose of aspirin for patients with heart disease. Although aspirin has been used as a secondary prevention method for nearly three decades, the question of whether low-dose or high-dose aspirin is more beneficial remains unanswered.
Both the cost and complexity associated with running a traditional randomized clinical trial have prevented researchers from finding this answer. “A strong need has arisen to develop and execute more streamlined, pragmatic trials leveraging real-world data and technologies to generate real-world evidence to answer important clinical questions that have a direct impact on public health,” the paper’s authors write.
ADAPTABLE was designed to mirror routine health care as closely as possible to help support real-world decisions made in clinical care. Pragmatic elements of the trial included:
- Broad eligibility criteria to reflect criteria that clinicians use to diagnose atherosclerotic cardiovascular disease.
- Large-scale recruitment using electronic health records (EHRs) from members of PCORnet, the National Patient-Centered Clinical Research Network. One of the aims of the trial was to test PCORnet® capabilities for patient identification and recruitment, and ADAPTABLE successfully met their recruitment goal of 15,000 participants.
- Electronic informed consent via a web portal.
- Completely electronic participation, from randomization to data collection. Patients report their own data during scheduled electronic follow-up visits, eliminating the need for the clinic visits of a traditional trial. Patient-reported outcomes are then confirmed and reconciled using EHRs and claims data.
The elements tested within ADAPTABLE have the potential to make clinical trials more efficient and less burdensome for both patients and clinicians. Although the authors of the design paper recognize that not all studies will be as pragmatic as ADAPTABLE, the learnings gleaned from ADAPTABLE can be used to implement some of the study’s features into other trials, creating hybrid studies that straddle the line between fully pragmatic trials and traditional randomized clinical trials. This will be an especially important focus for the DCRI as the FDA becomes more interested in studies that produce real-world evidence, as evidence by the agency’s Framework for Real-World Evidence.
DCRI fellow Guillaume Marquis-Gravel, MD, MSc, was lead author of the design paper. Other DCRI contributors to the paper include ADAPTABLE project leader Holly Robertson, PhD; Michael Pencina, PhD; Brad Hammill, DrPH; Adrian Hernandez, MD, MHS; and Schuyler Jones, MD. Matthew Roe, MD, MHS, and Lisa Berdan, MHS, both formerly of the DCRI, also contributed to the paper.