Researchers Discuss How One Aspirin Study Can Transform the World of Clinical Trials

Duke Clinical Research Institute 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. The DIA meets every year to bring together key thought leaders and innovators from across all disciplines involved in the discovery, development, and life cycle management of health care products.

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 during separate sessions about their progress with the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) study.

Heart disease is the leading cause of death for both men and women. About 610,000 people die of heart disease in the United States every year. It accounts for one in every four deaths and is a disease that places enormous burdens not only on patients and their families but on the nation and its healthcare system as a whole. 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 study hopes to improve care and outcomes for patients with heart disease. The trial is the first pragmatic trial, or a trial designed to reflect “real-world” conditions, conducted through PCORnet, the National Patient-Centered Clinical Research Network. Uniquely, its study design incorporated input from patients, physicians, and other stakeholders.

The trial, which will enroll 20,000 patients across the United States, provides a new model of enabling pragmatic research through electronic screening, consent, and follow-up. 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, self-randomize and report data directly through an online portal. In addition, with participants’ consent, electronic health information captured during routine care will be used to identify events that will provide ADAPTABLE researchers with additional health outcomes data to inform better decision-making.

Curtis’ session, chaired by Duke Clinical Translational Research Institute 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 and provides a streamlined, efficient way to use the data.

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.”

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.