By Michael Hughes, YPrime
Traditionally, patient consent for a trial has involved in-person consultation and paper-based processes; however, this practice has become progressively more outdated in the face of increasingly complex trial protocols, digitalization, and the growing integration of connected devices as part of a study design. The proliferation of both patient-centric (decentralized) and hybrid trials has created a need for more individualized, simplified, accessible processes involving trial participants.
Electronic consent, or eConsent, digitalizes the trial participant consent process through increasingly simplified, interactive, educational models designed to improve comprehension and boost engagement. By organizing information about a study into easily navigable, digestible components and supplementing that information with visual and audio elements, trial organizers can give participants greater insight into a study’s design and their part in it, improving retention and enhancing subsequent study activities. Making the informed consent process truly patient-centric means taking full advantage of the capabilities of digital technology to improve the patient experience from the moment they begin the process through the moment they agree to participate in the clinical trial by signing the eConsent form.