In the realm of clinical trials, especially those involving acute medical events like stroke, the University of Cincinnati and the University of Minnesota have spotlighted a change that could streamline the recruitment process: electronic informed consent, or eConsent. A recent study published in the journal Stroke provides quantitative support for the claim, indicating that eConsent could lead to higher enrollment rates in stroke studies and better adherence to consent documentation, both crucial aspects for the integrity and speed of clinical research.
The use of eConsent was analyzed in the Phase 3 MOST trial. The numbers are telling: 33.7% of participants were enrolled using eConsent, and 56.1% of trial sites used it at least once, showing a marked preference for the electronic method over traditional paper forms, and these figures seem to illustrate a shift in the way clinical research could be conducted in the future for the benefit of patients and researchers alike. According to Iris Davis, a clinical research manager at UC and administrative co-director of NIH StrokeNet, according to UC news, "EConsent provides a contemporary solution to documenting informed consent in clinical trials for patients, researchers and health care systems." She relayed her enthusiasm for this technological adoption in an interview with NeuroNews.
Further emphasizing the potential of eConsent, trial sites that employed the digital method enrolled a notably higher number of participants than those that didn't—the implication being that eConsent not only modernizes the process but could also ramp up the pace at which clinical trials achieve their required cohort sizes. The study's authors believe that eConsent adoption in future acute ischemic stroke clinical trials and stroke research networks could greatly enhance trial efficiency by broadening patient participation opportunities, reducing regulatory reporting duties for teams, and streamlining data management, Iris Davis explained that "A shift towards using eConsent over paper consent could improve the efficiency of stroke trials by providing more patients the opportunity to participate, and by decreasing the regulatory reporting burden on research teams," in a conversation with NeuroNews.
