Health Literacy in Clinical Research

Because of the individualized nature of drug and therapeutic treatments, clinical trials require participants who represent the diversity of the patient base. If early trials do not have a broad patient base, it can be difficult to know who may or may not benefit from or respond to a treatment later. In addition to diversity in recruitment, informed consent during participation is also crucial. If participants do not fully understand what they are signing up for, they may become confused, mistrustful, or drop out of a trial altogether, confusing investigators and possibly affecting the generalizability of a study.

To explore the incorporation of health literacy practices into clinical trials, the Roundtable on Health Literacy convened a workshop titled Clinical Trials: Practice and Impact on April 11, 2019, in Washington, DC. The workshop presentations and discussion centered around issues related to the challenges or barriers for diverse populations' participation in clinical trials, best practices for clinical trial sites and researchers incorporating health literacy practices, and effective health literacy strategies for clear communication with participants. This publication summarizes the presentation and discussion of the workshop.

• Front Matter
• 1 Introduction
• 2 Health Literacy as an Ethical Imperative in Clinical Trials
• 3 Embedding Health Literacy in Clinical Trials to Improve Recruitment and Retention
• 4 Experiences Implementing Health Literacy Best Practices in Clinical Trials
• 5 Designing Clinical Trials with Health Literacy Best Practices
• 6 Reflections, Research Directions, and Potential Opportunities for Implementation
• Appendix A: Workshop Agenda
• Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists