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Introduction1
The Roundtable on Health Literacy convened a workshop titled Clinical Trials: Practice and Impact on April 11, 2019, in Washington, DC. The workshop planning committee invited speakers and audience members to discuss the following topics:
- Why are health literacy practices important for clinical trials?
- What is the state of the science for incorporating health literacy practices into the design and execution of clinical trials?
- How can health literacy improve the quality and outcomes of clinical trials?
- What are the challenges and best practices for incorporating health literacy into clinical trials?
The workshop’s complete Statement of Task can be found in Box 1-1 and the agenda can be found in Appendix A.
Clinical trials serve as the bedrock of successful diagnostic, preventive, and treatment interventions, and can serve patients experiencing any stage of a condition, disease, or syndrome. Those who participate in clinical trials provide a great service to the broader medical community because, through
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1 The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at this workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.
their willingness to experience the benefits and risks of a clinical trial’s intervention, they help the medical community develop drugs and therapies that are most helpful to patients. However, 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.
The workshop was opened by Lawrence G. Smith, dean of the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and physician-in-chief at Northwell Health, who offered some observations to set the stage for the day. “Many people who enroll in clinical trials do so during periods of extraordinary clinical fright. They want access to treatment and are not as focused on reading through the informed consent paperwork. And, as many of us in this room may know, having a higher education seems to have little effect regarding comprehension when it comes to informed consent paperwork,” said Smith. He added, “We need to increase participation in clinical trials among underrepresented groups,” and named several examples of such groups:
- Individuals with impaired health literacy
- Individuals for whom English is not their first language
- Individuals with lower educational attainment
- Individuals from lower socioeconomic backgrounds
Smith also highlighted immigrant populations as being especially underrepresented and encouraged the medical community to take the lead on increasing immigrant population participation.
ORGANIZATION OF THE PROCEEDINGS
The remainder of this proceedings summarizes the discussions that took place throughout the workshop and highlights key lessons, practical strategies, and the needs and opportunities for using the principles of health literacy to increase quality and outcomes in clinical trials. Chapter 2 explores the ethical imperative of incorporating health literacy practices in clinical trials. Chapter 3 offers strategies for improving recruitment and retention in clinical trials by embedding health literacy practices along every phase of the trial. Chapter 4 provides several examples of health literacy practices in action, including strategies for implementing interventions, improving patient centeredness, and addressing common barriers to participation in clinical trials. Chapter 5 summarizes a panel discussion on future steps and Chapter 6 covers possible research and policy directions along with reflections from the roundtable members and two workshop speakers. Appendix B contains the speaker biosketches.
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