Electronic Consent Shows Promise to Address Key Barrier in Stroke Research Recruitment

Recent post-hoc analyses of a large clinical trial highlight the benefits of electronic informed consent (eConsent) in acute ischemic stroke research. The study revealed that eConsent not only enhances enrollment rates but also improves adherence to consent documentation, addressing a significant hurdle in stroke trial recruitment.

The findings, published in the journal Stroke, were led by Iris Davis from the University of Cincinnati, with collaboration from Christopher Streib of the University of Minnesota. The research emphasized that obtaining timely informed consent is a major challenge in acute stroke trials, often delaying patient inclusion. eConsent offers a solution by enabling electronic delivery and documentation, which can streamline the consent process, especially for remote participants.

In the analysis of the Phase 3 MOST trial—assessing blood-thinning medications alongside standard stroke treatment—researchers compared traditional paper consent with electronic methods. They found eConsent was used in approximately one-third of participants, with a higher adoption rate across participating sites. Notably, eConsent was most frequently completed remotely, significantly increasing access for patients unable to be present in person.

The study also demonstrated that in-person eConsent resulted in better documentation adherence compared to paper-based approaches, with fewer errors and reportable events. Additionally, eConsent sites enrolled more participants overall, especially those opting for remote consent, which highlights its potential for expanding trial accessibility.

Expert opinions suggest that the advantages of eConsent extend beyond stroke studies, applicable to various time-sensitive medical trials such as thrombectomy or thrombolytic research. Despite regulatory and infrastructural challenges, including IRB restrictions and the need for robust systems, eConsent could be especially valuable in rural settings, where logistical barriers limit patient participation.

Overall, eConsent provides a modern, efficient alternative that could improve clinical trial participation, regulatory compliance, and data quality in stroke research and beyond.