Laurie Myers, MBA, Merck & Co., Inc.

Communicating with patients about clinical trials is challenging in today’s increasingly complex world of treatment options. While access to information about clinical trials is more widely available, patients with serious illnesses can be easily overwhelmed before they fully understand their options. This gap between access and understanding affects the decisions that patients face when deciding to continue conventional therapy or participate in a research study. Health literacy awareness is a significant step toward engaging more effectively with patients and helping them to make the best decisions for their health. This article is based on a presentation at the 15th Annual Meeting of ISMPP, April 15-17, 2019.

What is health literacy?

Making informed decisions about one’s health depends upon the ability to gather information, process and understand that information, and take appropriate action.1 Health literacy depends upon:

  • Oral literacy: Speak and listen effectively2
  • Print literacy: Read, write, and take meaning from information2
  • Numeracy: Understand and use numbers2
  • Information literacy: Find and apply health information3
  • Digital literacy: Use digital tools like smartphones, computers, or tablets to get information4,5

Why is health literacy important to patients?

Low health literacy predicts poor health more than any other factor—age, race, income, employment, or education. People with low health literacy are less likely to access the healthcare services they need and to use those services appropriately. They have more trouble managing chronic conditions, changing their behavior, and taking action in response to advice and information about their health.

Low health literacy levels are more common in certain populations, including people aged 65 years and older, the unemployed, racial and ethnic minority groups, and those who did not finish high school. People who do not speak English, or use English as a second language, are also at risk, as are those covered under Medicaid in the United States. But it is important to recognize that other factors, like a new diagnosis or concern for a loved one, can make it hard for even people with high levels of health literacy to use health information. Applying health literacy principles to clinical research communications helps all people make good decisions about their health.6

Why is health literacy important to clinical trials?

Advancing innovation in healthcare treatment options depends on effectively conducting clinical trials. Regardless of whether it’s a large trial that includes thousands of people or a small study to treat a rare disease, researchers need to show that the findings apply more broadly. To do this, participants should reflect the diversity of society, including people with different levels of health literacy. Explaining the trial in an understandable way aids in diverse recruitment, encourages a partnership with the research team, and fosters participants who are informed and consenting. Participants with a good understanding of the clinical trial may be more likely to follow the protocol, ultimately producing more accurate and complete data.

The data collected in clinical trials are under increasing scrutiny by patient advocates, government regulators, and publishers of medical and scientific journals. Incorporating health literacy principles aligns with the trend toward data transparency sought by these and other groups.

How can you ensure that clinical research communications are health literate?

Addressing low health literacy means providing health information in ways most people can understand. Using plain language and clear, simple graphics are effective ways to present information. Incorporating these and other health literacy principles into clinical research communications helps keep patients informed and engaged throughout the clinical trial process (see Figure 1 below).

Figure 1. How to incorporate health literacy principles into clinical research communications

What can you do to promote health literacy?

Clinical trials provide many opportunities for medical publication and communication professionals to apply the principles of health literacy. This does not mean you need a completely new approach, or that you need to do more. You will do what you already do, but in a better way, by integrating health literacy principles into medical communications and eliminating jargon (see Figure 1 above). Doing so helps educate and inform participants, which is a big part of conducting clinical trials. Written clinical research materials that are readable, clear, and informative protect participants and support the integrity of the trial.

The principles of health literacy can be applied to every step in the clinical trial process:

  1. Use patient-focused recruitment materials and a clear informed consent to encourage enrollment.
  2. Support participants with materials that explain the importance of their role in the trial.
  3. Apply health literacy principles when developing packaging, labeling, and instructions for using the study drug (see Figure 2 below).
  4. Prepare a lay summary of the trial, and post it online to inform participants.
  5. After drug approval, apply the same health literacy principles to information that patients receive about their disease and treatment.

Figure 2. Injection guide for study drug: before and after applying health literacy principles



Merck & Co., Inc. example with input from Health Literacy Media

How can you overcome potential objections from your team?

When adopting good health literacy policies, sometimes the most difficult hurdles can be internal. Educating your team on the benefits of health literacy and dispelling common myths can go a long way toward overcoming objections. For example, while patient-focused materials are often shorter and less detailed, that does not diminish their meaning or invite liability. Writing in a health-literate way improves precision, which can reveal unclear and unnecessary content. Policies that encourage health-literate writing styles are being applied all over the world with successful results.10,11

Making the transition can take some effort but switching from a “disease focus” to a “patient focus” helps to improve patient communications while increasing compliance. The U.S. Centers for Disease Control and Prevention (CDC) promotes plain language as one effective strategy for increasing medication adherence.9

Additionally, writing with health literacy principles in mind does not contribute to medical or regulatory negligence. The opposite is true. It protects against medical and regulatory negligence by ensuring the clear communication of risks. In fact, many studies have shown that clear communication increases understanding, which can decrease legal liability.12-14

What is the takeaway?

Medical communication professionals can be confident communicating in ways that are clear, understandable, and informative throughout the clinical trial process. When we integrate health literacy principles into all clinical research communications, we connect more effectively with patients, which forms the basis for good clinical trials and leads to better healthcare for all of us.

If you want to learn more about health literacy as it relates to clinical trials, be sure to attend the 16th Annual Meeting of ISMPP to hear from a co-collaborator on a recent health literacy in clinical research project, toolkit, and website. A representative from the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard will speak to the project and its applicability for communication professionals on Tuesday, April 21, 2020.

Acknowledgments: Medical writing and editorial assistance was provided by Carolann Murphy, PA, and Jodi Rintelman, PharmD, of Churchill Communications (Maplewood, New Jersey). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.


  1. US Dept of Health and Human Services. (2015). Quick Guide to Health Literacy. US Dept of Health and Human Services.
  2. Agency for Healthcare Research and Quality (AHRQ). (2011). Executive Summary. Evidence Report/Technology Assessment Number 199. Health literacy interventions and outcomes: an updated systematic review. Retrieved from: Accessed September 7, 2018.
  3. National Network of Libraries of Medicine (NNLM). Skills needed for health literacy. Retrieved from: Accessed September 7, 2018.
  4. Cornell University. (2009). What is digital literacy? Retrieved from
  5. American Library Association. (2013). Digital literacy, libraries, and public policy: Report of the Office for Information Technology Policy’s Digital Literacy Task Force. Retrieved from
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  7. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. Health Literacy in Clinical Research. Accessed from:
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  13. Meade, Cathryn. (1999). Improving understanding of the informed consent process and document. Seminars in Oncology Nursing, 15(2), 124–137.
  14. Trudeau, Christopher R. (2016). Health literacy: the missing link to reducing risks and improving outcomes. A Publication of the American Health Lawyers Association Hospitals and Health Systems Practice Group, 18(3), 1–4.
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