Tips For Tailoring eConsent For Optimal Patient Centricity

While informed consent is a critical process for ensuring participant autonomy in clinical research, consent forms are too long, unclear, difficult to read, and frequently exceed 9th grade reading levels. This has been demonstrated in COVID-19 vaccination trials,¹ in oncology trials (where the average consent form is over 7,000 words),² and in many other settings.³ Various stakeholders share this view, including IRB chairs,4 patients, advocates, caregivers, and care partners.⁵ Because the goal of informed consent is to assure that a participant can make a voluntary, well-informed decision regarding trial participation after carefully weighing potential risks and benefits, it is critical that the process be tailored to ensure that participants understand what’s being asked of them and how their data will help further future disease treatment.

Failure to adequately inform participants such that they fully comprehend what is expected of them can also impact the success of a clinical trial and increase in drop-out rates. According to Tufts researchers clinical trials in a variety of therapeutic areas experience patient dropout rates close to 20 %.⁶ And, although every patient dropout cannot be attributed to failures of the consent process, Advarra’s 2021 research titled “Retention in Clinical Trials” highlights a key link between consent and dropouts.⁷ According to Advarra, “35% of patients who dropped out of a study early reported that it was difficult to understand the Informed Consent Form compared to just 16% who completed their trial.” Advarra concludes that patients were more likely to continue the study if their expectations were appropriately set during the informed consent process, including what study participation will entail, what actions are required to be taken by the participant, and most importantly, where to turn should questions arise; all areas that can be better addressed with the features of eConsent Participant dropout is costly, with an average estimate of $42,000 lost per phase 3 trial patient dropout.⁸ If dropouts result in trial delays, the costs increase: estimated lost revenue for delaying a trial is 600k to 8M every day.⁹