Adrian Hernandez, MD, MHS, and his co-authors outline how the study has the potential to change how clinical trials are conducted.
An upcoming study comparing two doses of aspirin for secondary prevention of cardiovascular events in high-risk patients will answer an important clinical question while simultaneously testing a new approach to conducting pragmatic clinical trials. The authors of a commentary in Annals of Internal Medicine explain the significance of this effort.
The article was written by the DCRI’s Adrian Hernandez, MD, MHS; Rachael Fleurence, PhD, of the Patient-Centered Outcomes Research Institute (PCORI); and Russell Rothman, MD, MPP, of Vanderbilt University.
Known as ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness), the trial is the first to be facilitated by the National Patient-Centered Clinical Research Network (PCORnet). PCORnet is a “network of networks” created by PCORI to overcome the challenges that make medical research expensive, inefficient, and slow to provide results.
The mission of PCORnet is to support rapid and efficient randomized comparative effectiveness trials embedded in the delivery of usual care. In the ADAPTABLE trial, health record data collected during usual care will be used to identify, recruit, and follow up with research participants. Once the study is complete, researchers will have answers about aspirin and a better understanding of PCORnet’s capacity to accomplish its core mission.
“As ADAPTABLE progresses,” the authors write, “we believe it will illuminate PCORnet’s remarkable new approach to conducting pragmatic clinical trials and demonstrate how ‘big data’ can be leveraged to enhance the efficiency of clinical trials by facilitating the identification, recruitment, and follow-up of research participants.”