Readable Consent Forms Could Boost Trial Enrollment: Oyepeju Abioye-Akintola, MD, MSc

Oyepeju Abioye, MD, MSc, a third-year internal medicine resident at Allegheny Health Network, founded Protocol & People earlier this year as a public initiative to demystify clinical trials for a lay audience. Clinical trials strike most people as an abstract, intimidating concept, she explained in a new interview with The American Journal of Managed Care^®, with many assuming participation means being an experimental subject without understanding the actual stakes or safeguards involved. Abioye emphasized that trials often represent the frontier of emerging, life-saving treatments, and the people who enroll are typically the first to benefit from that progress. Using plain-language posts, infographics, videos, and even comics, Protocol & People aims to close the gap between what the public understands about trials and how they might personally benefit, particularly in the fast-evolving field of oncology.

Building the initiative pushed Abioye to scrutinize clinical trial documents directly, and informed consent forms stood out as a clear problem. Reading them from a patient’s perspective, she recognized that when people can’t understand the paperwork, they can’t explain their hesitation to their oncologist—and existing medical mistrust only compounds the barrier. Notably, she’s found that formal education level doesn’t reliably predict health literacy, reinforcing that this is a design problem, not just an outreach problem.

On what “fixing” a consent form actually means, Abioye points to plain-language principles: leading with essential information, cutting unnecessary jargon, and doing so without sacrificing accuracy, a genuine tension, since simplifying language risks understating important details. She was candid that measuring impact is the harder task. Her proposed approach starts with quantifying the current gap—comparing the reading level of existing trial documents against recommended standards for patient materials and average educational attainment—to establish baseline numbers. From there, simplified consent documents would go through multiple rounds of revision to preserve accuracy while improving readability. The real test, she said, is comparing trial enrollment rates before and after simplified documents are introduced to see whether readability improvements actually move enrollment numbers rather than just feeling more accessible.