March 7, 2016 – In a recent editorial, the DCRI’s Robert Mentz, MD, and his colleagues suggest changes are needed to make GCP guidelines compatible with pragmatic clinical trials.
The tension between the realities of running a pragmatic clinical trial and adhering to Good Clinical Practice (GCP) guidelines could be eased by updating those guidelines, according to a new editorial by DCRI researchers.
The editorial, by Robert Mentz, MD; Adrian F. Hernandez, MD, MHS; Lisa G. Berdan, PA, MHS; Tyrus Rorick, RN; Emily C. O’Brien, PhD; Jenny C. Ibarra, RN, MSN; Lesley H. Curtis, PhD, and Eric D. Peterson, MD, MPH,appears in the current issue of the journal Circulation.
The GCP guidelines were established 20 years ago to help ensure the safety of participants in clinical trials and the validity of trial findings. Pragmatic clinical trials are designed to test interventions in real-world settings rather than strictly controlled environments, which sometime bring them into conflict with the GCP guidelines.
Such tension could be resolved, the authors suggest, by updating the guidelines to account for research that incorporates aspects of pragmatic trial design and is conducted with data gathered from electronic health records and registries. They also offer a path forward for pragmatic research under current GCP guidelines by outlining strategies for areas that include participant enrollment, monitoring, study visits, participant follow-up, and documentation.