Stop Papering Over Consent Problems: Leverage eConsent For Clinical Trial Patients

By Vinita Navadgi, Sr. Director, Product & Strategy, Patient Consent, IQVIA

Clinical trials are a crucial component of commercializing ground-breaking medicines. For a study to be successful, however, patients must agree to a variety of procedures and actions necessary for conducting research. This can be a complicated process, often fraught with unknowns. To make informed electronic consent (eConsent) more streamlined and ensure that all parties involved are handling it with the proper rigor, regulatory bodies around the world, including health authorities and institutional review boards, oversee the process. This entails providing a participant with a genuine understanding of the protocol, its potential advantages, and risks rather than just getting their signature on a consent form.

At its core, informed consent is a process in which participants must:

• Receive adequate information about the trial and their participation.
• Are given the opportunity to consider, ask questions, and receive answers.
• Confirm that they fully understand the implications of participating.
• Agree to their participation and provide ongoing data for the trial and beyond, if required.

Despite the proven benefits of eConsent, sponsors have been hesitant to adopt the platforms beyond the pandemic. Modern technology adoption and behavior change can be challenging, but the benefits eConsent provides to all stakeholders far outweigh the adoption hurdles.

Learn more about how eConsent solutions can simplify the trial experience for both site staff and patients.