June 27, 2016 – The DCRI’s Adrian Hernandez, MD, MHS, and Lesley Curtis, PhD, examined the challenges and opportunities of running one of the largest pragmatic clinical trials.
DCRI researchers discussed how one of the largest pragmatic clinical trials in history has the potential to transform clinical research at this year’s annual meeting of the Drug Information Association (DIA) in Philadelphia.
Adrian F. Hernandez, MD, MHS, director of Health Services and Outcomes Research, and Lesley Curtis, PhD, director of the Center for Pragmatic Health Systems Research, spoke on separate sessions about their work with the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) study.
ADAPTABLE is designed to compare the effectiveness of two daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. The trial is the first demonstration project conducted through PCORnet, the National Patient-Centered Clinical Research Network. Uniquely, its protocol and consent form were created with input from patients, physicians, and other stakeholders.
The trial, which will enroll 20,000 patients across the United States, poses a number of technological challenges. Hernandez’s session focused on the lessons learned from establishing a technological process suited for tens of thousands of patients who are being studied in a variety of clinical settings across the nation.
Using electronic health records (EHRs) and web-based technology, participants will self-consent and report data directly through an online portal. In addition, electronic health information captured during routine care will be used, with participants’ consent, to identify events that will provide ADAPTABLE researchers with additional health outcomes data to inform better decision-making.
Curtis’ session, chaired by DTRI Project Leader Shelley Rusincovitch, was devoted to a discussion of the PCORnet Common Data Model (CDM). The CDM, a key component of ADAPTABLE, is a way of organizing data into a standard structure.
The PCORnet CDM was influenced by similar models used by initiatives such as the U.S. Food and Drug Administration (FDA) Sentinel, a program sponsored by the FDA to create an active surveillance system to monitor the safety of FDA-regulated medical products. Both Sentinel and PCORnet use a distributed data approach in which project partners maintain physical and operational control over electronic data while the CDM is used to standardize administrative and clinical information across all of the partners.
The PCORnet CDM has further expanded the possibilities for data sharing and management, Rusincovitch said.
“The CDM is powerful because of the role it plays in EHR-driven research,” she said. “If we’re working with multiple institutions and databases, the CDM provides a common foundation to build upon. That’s what makes it so useful in this context.”