How health literacy can improve clinical trials: Increasing understanding, relevance, and usability

Updated: Sep 5, 2018

At Health Literacy Media’s Clearly Communicating Clinical Trials (C3T), we’ve designed and conducted research, written summaries of clinical trials for the public, made consent forms truly informative, and conducted a broad range of health literacy interventions. Based on our experience, health literacy offers the greatest potential to improve and advance clinical trials.


How health literacy can improve clinical trials: Increasing understanding, relevance, and usability

By Andrew Pleasant, Ph.D.; Diane Webb, MPH, CHES; Matthew Stevens; Allen Todd, Deborah Collyar; and Catina O’Leary, Ph.D., LMSW


Health literacy is one of the newest additions to clinical trials. Researchers have only explicitly considered the role of health literacy as an aspect of the success or failure of clinical trial design, conduct, and reporting for less than 17 years.


That brief history is a drop in the bucket of the 271 years since James Lind conducted what is widely regarded as the first clinical trial in 1747.


In fact, not until 8 years ago does a scholarly article truly seem to focus on the role of health literacy in clinical trials.[1] Although – as is always the case in the history of health literacy– people have researched aspects of the core issues of health literacy in clinical trials without actually using the exact phrase for much longer.

Based on our experience, health literacy offers the greatest potential to improve and advance clinical trials. At HLM’s Clearly Communicating Clinical Trials (C3T), we have:

  • designed and conducted research,

  • written summaries of clinical trials for the public,

  • made consent forms truly informative, and

  • conducted a broad range of health literacy interventions.


What can health literacy bring to clinical trials?

Health literacy is one of, if not the, strongest influences on people’s health and the use of health services.[2]


Clinical trials face many challenges. Most are summed up in words like diversity, recruitment, informed consent, retention, participation, and reporting. Health literacy has a positive effect to make upon clinical trials in each of those areas.

On a broader level, we face challenges in the relationships between medical professionals, health systems, and society. For example, in 1966, more than three-fourths of Americans had great confidence in medical leaders; more recently, only 34 percent do.[3]


We must change how we communicate about health and medicine in order to maintain and build public support for medicine, medical professionals, medical research, and health systems overall.


Health literacy can lead the change to a healthier and more productive relationship between the generally non-scientific public and the people and institutions of health and medicine, including clinical trials.


Such a shift can successfully target the erosion of the public trust in leaders of the medical system as well as health care systems as a whole. We all too often witness the failure of clinical trials and are working to implement new rules around the world attempting to increase the understanding and relevance of clinical trials.


Yes, health literacy can help with all those issues.


In order for clinical trials to successfully increase public engagement, the public must see the relevance. That requires understanding. Understanding requires addressing health literacy in every element of the design, conduct, and reporting of a clinical trial.


At C3T, we bring over 100 years of collective experience in addressing health literacy and conducting scientific research. Let us help you bridge the gaps between the clinical trials you conduct and the public audiences whose participation, engagement, understanding, and support will make your research an even greater success.


[1] This seems to be: Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change. Herrera AP, Snipes SA, King DW, Torres-Vigil I, Goldberg DS, Weinberg AD. Am J Public Health. 2010 Apr 1;100 Suppl 1:S105-12. doi: 10.2105/AJPH.2009.162982. Epub 2010 Feb 10. PMID: 20147682

[2] See, for example, https://www.researchgate.net/publication/51501673 Low Health Literacy and Health Outcomes: An Updated Systematic Review. Article in Annals of internal medicine · July 2011 DOI: 10.1059/0003-4819-155-2-201107190-00005

[3] https://www.nejm.org/doi/full/10.1056/NEJMp1407373#t=article


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