18 Dec From Participants to Partners: An Urgent Call to Transform Patient Engagement in Clinical Research

By Jena Daniels, ACRP

Engaging patients in clinical research has long been seen as important, yet it has been slow to evolve. For years, clinical research has largely been designed with the assumption that participants should conform to rigid protocols, often neglecting the voices of the very people who will be impacted most by the outcomes. A 2018 study, published in Research Involvement and Engagement, estimated that far less than 1% of clinical trials meaningfully and actively engage patients in any part of the research process.

While too many clinical trials are centered around the convenience of researchers and sponsors rather than patients’ needs and preferences, this paradigm is shifting—thanks, in part, to the U.S. Food and Drug Administration’s (FDA’s) June 2024 draft guidance on submitting Diversity Action Plans, which requires sponsors of certain clinical studies to submit plans that detail the steps sponsors will take to include underrepresented populations in their trials, addressing factors such as race, ethnicity, age, and sex. The FDA also highlighted the importance of early patient engagement in trial design and planning, illuminating the significant value of patient advisory boards. Read more…