Including simple, well-designed graphics in a plain language (lay) summary (PLS) can enhance the reader’s understanding of the technical aspects of a clinical trial. Graphics increase the readability of the summary by distilling key information into a more easily digestible format and enhancing sponsor messages. Understanding the plain language summary graphical method is important for well-structured graphics.
Clinical Trial Regulation No. 536/2014, expected to go into effect in January 2022, will significantly expand the footprint of clinical trial transparency by requiring PLSs for all phase 1-4 interventional clinical trials. Complying with this recent policy shift and meeting established timelines will require a considerable increase in efficiency when preparing PLSs.
When the regulation goes into effect, all PLSs will be submitted to the Clinical Trials Information System (CTIS), hosted by the European Medicines Agency (EMA), within 12 months of the clinical trial end date for adult studies and within 6 months of the clinical trial end date for pediatric studies.
Although there are many resources available for navigating the complexities of drafting PLSs, there are far fewer when it comes to creating effective PLS graphics.
Below are 5 tips for the successful creation of PLS graphics.
Keep It Simple
The main objective of a plain language summary is to help clinical trial participants understand a clinical trial’s complexities. To do this, a plain language summary writer must consider that the audience may not have any medical background knowledge. Thus, the writer and designer should try to approach each subject and subsequent graphic from the perspective of a nonexpert.
The designer must review a technical report and be able to condense it into the simplest possible form. Every element used in a plain language summary graphic should add value and promote an easier understanding of the material, so the designer should avoid unnecessary text or complicated iconography.
All items are subject to the reader’s interpretation, and they may not be perceived as intended. The graphics should be easy to digest with minimal context, but not so simple that they are no longer meaningful. Finding the perfect balance is what leads to an effective plain language summary graphic.
Additional guidelines for creating plain language summary visuals can be found on the EMA’s website.
Stay True to Size
No matter what the deliverable, it is important to be aware of all sizing requirements. The length of a plain language summary document will vary based on the sponsor or the country of publication. A graphic designed to be much larger than the final product can accommodate may result in severely diminished readability and require rework.
To avoid legibility issues, always consider the smallest font incorporated into the image, and then design for the space allotted. When in doubt, consider referring to available sample documents.
Consider Your Colors
When creating a graphic, color is one of the most influential tools in a designer’s toolbox. Traditional color theory has been expansively studied starting as early as the 15th century, and for good reason.
- Influence mood and behavior;
- Affect perception;
- Convey messages without using language.
With so many color options, it can be difficult to know where to begin. Quite often, sponsors have specific branding practices that the designer should follow, which could be as extensive as a full branding guide or as limited as a few preferred colors. Keep in mind that plain language summary branding practices may not always directly align with an organization’s branding guidelines.
In the case where no starting material exists, it is up to the designer to choose the palette. Customarily, a cooler color palette is used in the healthcare industry, due to the calming effect it tends to have on individuals. The leading color affiliated with healthcare is blue, and this is derived from the color’s associations with trust, dependability, vitality, and strength.
While blue is standard for the healthcare industry, it may not always be the appropriate color choice. It is crucial to have an understanding of the audience, the indication, and stakeholder expectations.
After finalizing the initial color, the designer can then determine the remaining color palette. A monochromatic color palette is a useful option to avoid an over-complicated plain language summary graphic. A monochrome palette requires the designer to select a singular impactful color, and then any additional colors would be shades, tints, or tones of that base color.
Lastly, it is essential to confirm the format of the final deliverable. This provides the designer with the method they use to produce the chosen color palette accurately. Graphics displayed on a screen should use an additive color model (RGB), while plain language summaries distributed by print should use a subtractive color model (CMYK).
Choose Your Words Wisely
Creating plain language summary graphics varies depending on the sponsor or medical writer(s) with whom the designer is collaborating. In some instances, it is the responsibility of the designer to review the plain language summary document and compile the necessary information to create the graphics.
When that occurs, there are a few guidelines to remember:
- All language included should mimic the terminology included in the document itself
- Try to substitute language that may be difficult to comprehend with everyday words and explain the terms that cannot be simplified creatively, like in a call out
- Graphics included in a plain language summary document must be non-promotional
- Text should not be suggestive or allow the reader to deduce anything other than facts
- Discuss sponsor-specific terminology preferences such as the use of “patient” versus “person.”
Communication Is Key
The key to successful relationships is communication, and relationships between a medical writer and a graphic designer are no different. Maintaining an open communication channel is essential when starting a new project. Spending a little extra time developing a healthy relationship can result in a positive work experience, and sustaining frequent communication may reduce the quantity and extent of needed revisions.