NEJM Highlights How the ADAPTABLE Study is Changing Clinical Research

ADAPTABLE’s electronic consent processes and web-based design are featured in a multi-part review article by the New England Journal of Medicine on The Changing Face of Clinical Trials. New approaches to informed consent and innovative options for obtaining it have come about from technological advances and pragmatic research designs.

While answering the question of what is the best dose of aspirin for patients with heart disease, ADAPTABLE provides an innovative model to conduct pragmatic clinical trials. The ADAPTABLE study portal offers potential participants the opportunity to learn more about the study by watching a video and reading the consent form. If interested in participating, individuals self-consent, self-randomize, and return to the portal every three to six months to answer questionnaires and report data. In ADAPTABLE, participants do not need to have in-person study visits. Instead, electronic health records are used to identify participants and electronic health information is captured during routine care to identify events that provide researchers with additional health outcomes data to inform better decision-making.

In ADAPTABLE, patients are central to the study and have been involved in ADAPTABLE from the beginning, including consent development. Patients provided feedback and participated in interviews to help design the consent form that includes a comprehensive quiz. True for all studies, but especially for ADAPTABLE since the study is using web-based consent, the consent includes a six-item multiple choice quiz to assess a participant’s understanding of the study. You can read more about how the ADAPTABLE consent was designed by Duke Clinical Research Institute’s Program for Empirical Bioethics, headed by Co-Investigator, Laura M. Beskow, MPH, PhD.