Best Practices in Design for Clinical Trial Communications: The Mysterious Art of Typography

Typography in Clinical Trial Communications

Written by: Paul Hurd


CISCRP produces a wide range of patient-friendly materials, such as informed consent forms, brochures, and trial summaries. These communications provide important information to clinical trial participants or potential participants.

These documents are written in plain language and are graphically designed to be easily read and understood by a wide variety of people. Plain language strives to be easy to read, understand, and use. It avoids complex language and jargon. To aid in readability, formatting and typography play a large part in the design process.

To learn more about these document types and to see examples, click below:

Typography is the arrangement of type to make written language legible, readable, and appealing when displayed. This blog will focus on what makes typography work to achieve these goals. But first, some definitions.

 

Typeface vs. Font

Simply put, a typeface is a collection of fonts. A typeface defines a type’s general shape and design. Typefaces have names such as Arial, Helvetica, or Times New Roman. The font is the type size in points, weight (regular, bold), style (italic, condensed), and so forth of the typeface when it is used. But don’t worry if you can’t remember when to use the terms font or typeface. These days, people use the terms interchangeably.

In typography, bigger is better for creating legible text. Here at CISCRP, font sizes for paragraph text are generally 12 to 14 points. The bold font style is used to emphasize important information. Though an italic font may catch your eye, it is not used for emphasis because the slanted and distorted letterforms tend to inhibit legibility. ALL CAPITAL LETTERS ARE ALSO AVOIDED because they are difficult to read with their lack of ascenders and descenders. AND IT MAY SEEM LIKE YOU ARE YELLING.

Legibility is a result of the chosen typeface and font, its size, its spacing, and the contrast between text and background. It can also be affected by the layout of the text, such as the text orientation and length of lines.

Serif and Sans-Serif type

Serif typefaces have flared ends and corners. An example of a serif typeface is Times New Roman. Serifs are as old as written language and have been traced back to the Latin alphabet. Typefaces with no serifs are called sans-serifs. Arial is a sans-serif typeface. The earliest use of sans-serif type appears in printed media as early as 1805. In general, it is best to use a sans-serif typeface, especially in paragraph text. Studies have shown that sans-serif type aids legibility among people who are dyslexic.1,2

 

Is it pronounced leading, or leading?

Leading (“Leh-ding”) is the space between lines of text in a paragraph. The term comes from the early days when type was made of little blocks of metal. Leading (actual slivers of lead) was used to space the lines of words and letters from each other on the page before it was printed.

Normally, leading is set at 1.2 times the type size. So, a paragraph of 12-point type size would have each line spaced 14.4 points from each other, depending on the size of the type and letterform characteristics. Confusing? Yes, but you don’t have to remember that, either. Document and page layout programs already do that calculation for you.

What you should know is that for increased legibility, leading should be set higher than 1.2 times the type size. There is a “sweet spot” where the leading size increases readability and comprehension. This is especially important for people with dyslexia. Paragraphs with a leading size too small may look like a solid block. Too large a leading size and the readers’ eyes jump from one line to another and have trouble finding the next line. Again, this amount of leading varies by type size and what the letterform looks like. How much leading is just right? That is part of the “mysterious art of graphic design.” Not really. Experts recommend a leading of 1.5 times (150%) of the type size. For instance, a 12-point type size would have a leading space of 18 points. See the figure below for how this would look using the Avenir typeface.

Spacing between paragraphs is another important design consideration. Space between paragraphs is just as it sounds. It is white space, sometimes called a “carriage return,” between paragraphs. How do you know what size space should be used between paragraphs? A good rule to follow is that the space between paragraphs should be a little less than 2 times the leading. For instance, in the figure above, paragraphs of Avenir 12-point type would be spaced an additional 9 points from each other. Think of the measurement as 27 points of leading between paragraphs.

Here are some other considerations for readability in lines of text:

  • Do not break words from one line of text to another (hyphenating)
  • Keep numbers on the same line as the thing they describe (i.e., 13 participants, 3 weeks)
  • Whenever possible, keep the character count per line to 50–60, including spaces.

Type size, leading, and spacing between paragraphs is calculated to make use of white space or “negative space”. Why white space is important and how it aids in legibility will be explored in a future post.

In conclusion, when it comes to readability, the care you take with typography in a document can be just as important to plain language as the actual words.

Along with our plain language expertise, the legibility and accessibility of our printed and online educational and patient-facing materials are designed with the goal of improving participants’ experience in all stages of clinical research.

References

  1. https://dyslexiahelp.umich.edu/sites/default/files/good_fonts_for_dyslexia_study.pdf
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977080/

Medical Hero Spotlight: Ella Balasa, Cystic Fibrosis Advocate & Patient Engagement Consultant

Growing Up with Cystic Fibrosis

Ella Balasa was diagnosed with cystic fibrosis (CF) at only 18 months old, after suffering from constant sinus infections, upper respiratory infections, and a bout of pneumonia. One of three siblings, Ella jokes she won the ‘genetic lottery’, since she is the only one with CF in her family. Despite this, Ella had a relatively normal childhood.

“I spent a lot of time in the hospital being treated for lung infections when I was growing up,” Ella recalls. “My daily treatments and medical care made me feel different from the other kids my age, which was difficult.” Cystic fibrosis affects not only the lungs, but also the pancreas’s production of enzymes, which are needed for digestion. While in school, Ella would visit the nurse’s office daily before lunch to take her enzyme pills before eating.

In college, Ella chose to study biology and ended up working in a laboratory after graduation.

“It was in this role that I first realized my own experiences as a patient could help bridge the gap between research and patient communities,” Ella says.

At the time, her team was studying antibiotic resistance, something Ella had personally dealt with in her own medical journey. “I’ve had to use antibiotics frequently to treat lung infections, which over time means that my body has developed a resistance to them. There have been points in my life where treatments wouldn’t work for me because of this. It was interesting having this connection between my own life and the research we were working on,” Ella recalls.

Amplifying the Patient Voice in Research

Inspired by this connection, Ella started volunteering with the Cystic Fibrosis Foundation and joined several advisory committees. She was able to use her degree and experience to review study protocols and provide input about what the priorities and needs of patients are when developing new research studies.


It was through this early work with the Cystic Fibrosis Foundation and other groups that Ella began developing a more professional patient voice. Her connections led her to start working with larger industry groups to help develop patient-friendly communications about upcoming clinical trials and new treatments. Since 2020, Ella has committed herself to working full-time as a patient engagement consultant.

“My goal is to lend the patient voice into developing better treatments and services,” Ella says.

Since then, Ella has grown her industry connections by speaking on panels, at conferences, and by attending other events. She began branching beyond CF consultation, ensuring the patient perspective is represented within research for other rare diseases. Now, Ella works with industry professionals to identify and meet the needs of many different patient communities.

Phage Therapy & Clinical Research

Around the time she began getting involved in advocacy, Ella was invited to be a part of a documentary about CF where she met another patient who was receiving an experimental treatment called Phage therapy. “This was an alternative to the antibiotics I had become resistant to, so I was very interested in trying it,” Ella recalls. The next day, she contacted the research team at Yale directly and was approved to begin the medication.


The treatment was incredibly successful for Ella, which inspired her to write an article for Huffington Post about her personal experience with CF, antibiotic resistance, and seeking alternative treatments. “I was really excited to bring more exposure to the topic of antibiotic resistance because it is common for people with chronic conditions and isn’t talked about often,” Ella says.


Since her treatment in 2019, there has been a lot of advancement in the field of PHAGE therapy, with clinical trials now available and more research being explored.

Ella is a proponent of clinical trials, explaining, “The best way to bring new treatments to communities is by participating in the necessary research. As a patient, it’s a commitment that needs to be decided carefully, but if you do choose to participate, you become a piece of the larger puzzle that leads to new medications, therapies, and even cures. Patients can and should be involved in the decision-making process and outcomes of new treatments.”

Unfortunately, Ella is not eligible for most CF clinical trials because her lung function is below 40%, one of the most common general exclusion criteria used in research. “I believe it’s important to develop adaptive trial endpoints and protocol designs to make clinical research more inclusive to a broader population of patients,” Ella says. “Everyone wants new treatments, but the eligibility criteria often exclude the patients who need new treatments the most.”

Connecting Patients & Industry
“Empathy must be the root of all healthcare interactions. For there to be meaningful communication between larger pharmaceutical companies and the patients they are serving, there needs to be a desire to understand the needs of patients and the barriers they may be facing in their daily lives. Real patient care happens along the way, when industry provides support and interest in patients outside of their experiences taking a new medication,” Ella says.

A large part of Ella’s role as a patient engagement consultant is making sure patients are brought into the conversation early on, beginning with trial protocol development, all the way to the post-study dissemination of information.

“I view healthcare as a loop. As patients, we are one group that contributes to improving healthcare, but it can’t be done without the physicians and researchers, and industry organizations. They are our partners in advancing treatments,” Ella shares.
Advice For Aspiring Advocates

One of the most rewarding parts of Ella’s work has been the relationships she has been able to foster with other advocates. “I’ve seen the work that others are doing, and it inspires me to get even more involved,” Ella says. “The drive and passion that stems from all these individuals is amazing.”


If you’re interested in getting more involved within a patient community or becoming an advocate, Ella advises to start by sharing your story. “When you’re not afraid to share your story and ask questions, doors will open for you. Don’t be afraid to reach out and make those connections. I’ve reached out online to many organizations to share my ideas and volunteer for opportunities, and I’m so glad that I have.”

Additional Resources:

www.cff.org

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

For volunteer opportunities with CISCRP, visit our Volunteer page.

Written by Lindsey Elliott, Marketing & Communications Manager, CISCRP | lelliott@ciscrp.org

Why Diversity in Clinical Trials Matters – May 2023 Patient Diversity Campaign

Article from our 2023 May Patient Diversity Campaign

Clinical trials are a critical part of the research process for new medicines and vaccines. The information gained is fundamental to the development of new ways to help treat and prevent disease. Evidence has shown that some drugs and vaccines show variations in the response to some individuals depending on their racial or genetic background. For this reason, it is important that volunteer participants of clinical trials appropriately reflect the people that the investigational medicine or vaccine is intending to treat.

Our company, Merck, and many others, are working to ensure that volunteer participants from diverse backgrounds are included in clinical trials. Why is this so important? Age, gender, weight, race, or ethnicity might change how individuals respond to a treatment. By including people with varied traits and characteristics, research can provide important information to understand how treatments work in a diverse population.

There are many reasons why people volunteer for clinical trials – and many reasons they choose not to. In the United States, past medical mistreatment made some people distrust science and medicine. Financial or travel issues can also make it hard for people to join research trials. Too often, all those worries combined prevent people from volunteering.

That’s why we’re trying to make it easier for all volunteer participants.

The importance of diversity in cancer research

Diversity in clinical research is especially important in cancer research because the impact of cancer can be very different among diverse groups of people. For example, the American Cancer Society says prostate cancer is increasing. It also is 70% more common among Black men than White men in the United States. It’s important then that Black men are also a big part of research into the disease and the evaluation of investigational treatments.

Improving diversity in trials by reaching people in underrepresented communities

We need to do a better job engaging people in underrepresented communities and help them understand what participation in a clinical trial involves. Then we need to help those with challenges, like being too far from a trial or having financial concerns.

Partnerships with local organizations – groups who know their people best — can help. We’re also running our trials in more areas. Last year, about half of our clinical trial locations were placed in areas where underrepresented groups live to meet them where they are.

We recognize that there are things we can do to improve the clinical trial experience for volunteer participants, such as providing travel to and from clinical sites for their study appointments.

We know people often feel more comfortable with doctors and medical professionals who look like them too. So, we’re working to improve the diversity of clinical researchers. Plus, we’re creating tools to help health care professionals engage their patients about participating in trials.

We’re training more people to help volunteer participants through the clinical trial process called Patient Navigators. Patient Navigators can work with patients and medical staff as a go-between. We’re also looking at how to run trials so that some aspects may be easier for volunteer participants, like using telemedicine.

Working together to improve clinical research

We have a lot more to do, but we’re seeing progress. In 2022, we enrolled about 50 percent more diverse volunteer participants in our trials. It’s positive momentum we are working hard to grow, to make sure clinical research is an option for everyone.

You can help. Be open to learning more about clinical trials. Every trial has risks and benefits, and participation is completely optional and voluntary. You can stop at any time. Volunteer participants get to be active in their health and help advance medical research for everyone.

Authored by: Adrelia Allen, Senior Director, Clinical Trial Patient Diversity, Merck Research

Learn about Diversity in Clinical Research

Learn why diversity matters, how the clinical research process works, and gain information for specific communities.

Learn more >

How to Find a Clinical Trial

If you or someone you know is considering taking part in a clinical trial, this brochure is for you. It is intended to help you understand how to find clinical trials that are a good fit for you. We developed this brochure together with subject matter experts, patient advocates, and members of the public, to make sure the topics, language, images, and design are appropriate and engaging.

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This brochure was also reviewed by an Institutional Review Board (IRB), which is also known as an independent ethics committee. The IRB review ensures the brochure follows ethical guidelines for providing information about clinical research to patients and the public.

Topics Include:

  • What Clinical Trials are
  • How to Start Looking for Clinical Trials
  • Where to Look for Clinical Trials
  • What to Expect When Contacting Trial Staff

Spanish version of this brochure is coming soon.