According to the Institute of Medicine, there is a significant disparity between the health information people receive and actually understand. Even those in the health care industry can become vulnerable to not comprehending health information. When experiencing poor health or worry and stress about an unfamiliar condition for themselves or a loved one, even medical experts can struggle with comprehension. This is a problem throughout health care, including clinical trial content, and the problem becomes more acute for those with limited literacy skills.
The U.S. National Library of Medicine defines personal health literacy as “the degree to which individuals have the ability to find, understand, and use information and services to inform health-related decisions and actions for themselves and others. Examples of personal health literacy include understanding prescription drug instructions, understanding doctor’s directions and consent forms, and the ability to navigate the complex healthcare system.”
Improve Health Literacy by Using Plain Language
Using the principles of plain language fosters the creation of clear and understandable communication with the goal of increased comprehension and engagement for all literacy and educational levels. According to plainlanguage.gov, plain language is communicating in a way your audience can understand the first time they read or hear it.
Many studies have shown that plain language improves the bottom line by saving time, personnel resources, and money. And you will give better service to your readers.
The U.S. government’s Plain Writing Act, which was enacted in 2010, requires federal agencies to communicate in a clear, straightforward, and concise manner. Many different government departments have plain language guidelines to foster compliance with the act, which are largely applicable and helpful for any type of medical communication.
The consensus of these guidelines is that in plainly written documents, the audience can:
- Find what they need
- Understand what they find
- Use what they find to meet their needs
Tips for Using Plain Language in Clinical Trial Content
When writing content for clinical research materials, following the plain language helpful hints below will provide clear, direct, and understandable communications targeted to your audience. And, in clinical trials, the audience is diverse, ranging from all age groups of participants to health care providers. This form of writing is not intended to dumb down or oversimplify information. The goal is for the text to be compelling and vibrant, as well as understood by the intended consumer. The following information is a concise list drawn from many sources regarding plain language writing:
Getting Started
- Think about the intended audience for each material, research, and make notes while taking into consideration their current level of knowledge and demographics
- Note the purpose of the material(s) and the information the audience needs in each material
- Organize the information to have a logical flow
Writing
- Write for your reader
- Use headers and logical order
- State major points before going into detail, and make sure the main message is at the beginning of the document
- Include only details needed for the reader’s understanding
- Stick to one theme per paragraph and one idea per sentence (each sentence <20 words)
- Break the content up and organize it with lists and tables
- Avoid acronyms and abbreviations or explain them the first time used (maybe more than once)
- Stick to everyday language as much as possible, be precise and concise
- If uncommon terms must be used, define and use them consistently; you may need to lead the audience to understand with a comprehensive definition
- Use the most direct, strongest form of the verb possible, preferably in the present tense
- Use “must” instead of “shall” for required items or to indicate an obligation
- Consider using contractions with discretion to improve readability
- Use an active voice – write the actions the reader should do, and make sure they know who does what
- Use pronouns such as “you” so the materials feel relevant and draw the reader in; be sure to clearly define “you”
- Keep the subject, verb, and object close to each other
Finalization
- Proofread your work with fresh eyes a few days after you finish, and ask a colleague to review and edit
- Check for visual appeal
- Ask target audience members to read it to make sure it is appealing and logical to that group
By following these principles, your clinical trial materials will make sense to the level of the reader you are trying to reach. You will also convey your intended content in a clear and usable manner.
This blog was created to provide practical guidance and points to consider. However, there’s no mistaking the fact that creating clinical trial content is a huge undertaking. In many cases, it makes sense to bring in an expert. Imperial has extensive experience writing engaging and protocol-compliant materials for study participants and professionals. Feel free to call on us to create content for recruitment and retention materials, professional referral and networking materials, and site tools.
Download our free ebook, 6 Essentials When Writing Content for Clinical Trials, here: https://go.imperialcrs.com/content-for-clinical-trials
Updated 9/08/2025 and 7/22/2022
