Round-Up: Highlighting Recent Health Literacy Educational Materials

What is a placebo, Eligibility criteria, and How to find a clinical trial 

CISCRP is dedicated to providing educational resources and empowering people through all steps of clinical research participation. This includes everything from general awareness to what to expect during a trial. Or, as with one of our newer brochures, how to actually find a trial. We recently published three resources to help people understand certain parts about trials. 

Especially during Health Literacy Month in October (but also all the time), we can’t emphasize enough the importance of providing health-related education and tools to patients and the public. We’re constantly reviewing our materials and getting feedback from the public so we can fix any gaps in our resources. The ultimate goal is to provide guidance to help with decision making. To do this, we provide details, such as potential risks and benefits, clear action items, and a summary of possible options. And we strive to do this without actively encouraging participation and encouraging the reader to make the best decision for themselves and their loved ones. 

Each resource CISCRP creates, such as brochures, goes through a thorough review process to ensure the readers’ needs and the above goals are met. This includes writing, several editing steps, getting feedback from a Review Panel and surveys, getting internal feedback, and approval from an IRB. 

What is a Placebo?

If you asked a member of the public to pick the first word that comes to mind when they think “clinical research,” there’s a good chance they would say placebo. And then if you asked them to define it, they may say something like, “It’s just a sugar pill.” Since there’s a lack of awareness about clinical trials and how they work outside of CISCRP, that’s a fair guess. But it’s much more complicated than that. To help clear up the confusion for patients and the public, we updated our What is a Placebo? brochure.

The idea of a placebo has many parts. There’s why it’s used, how it’s used, and the “placebo effect,” for starters. There’s also the concern of not knowing whether or not a participant might receive a placebo. The brochure explains why it’s important that participants don’t know whether or not they receive a placebo, and why they can’t choose their treatment. It also explains how to know whether or not a placebo is even a possibility.

Then there’s the issue of randomization and blinding. How do researchers determine who receives a placebo? How does anyone know who gets what? Because many readers prefer visual mediums, we created a graphic structured a bit like a flow chart that shows treatment being randomized and that the participants and trial doctors usually don’t know who’s receiving what.

Eligibility Criteria for Clinical Trials


Our team—specifically, our events team that directly engages with different communities—heard from many different people at events that patients who want to join a trial are confused if they are told that they cannot join. Some people feel offended or upset, thinking that they were denied because of personal reasons. However, they may not be aware of eligibility criteria. So, we created an Eligibility Criteria for Clinical Trials infographic explaining the basics.

The immediate question many readers might have is why does it even matter? As mentioned in our graphic, eligibility criteria are necessary to protect participants’ safety and to get the most accurate results possible. Hopefully this explanation helps readers understand why researchers can allow only certain participants to join.

It’s vague to simply say “there are specific reasons why you can or can’t join,” so we provided some examples of both inclusion and exclusion criteria. This ranges from the most obvious, such as having the condition a treatment is designed to help, to other factors someone may not even think about, like needing to be a certain weight to join, or not being able to join because of having previous treatments that would affect how the trial treatment would work.

The infographic also provides patients who do not qualify or who did not want to participate with other ways to get involved and contribute to research. For example, participating in an observational study, joining an advisory board, or even simply discussing with friends and family.

And, of course, there may be other trials they can join.

How to Find a Clinical Trial

We have lots of information about clinical research participation, including helping to decide if participation is right for you (see our brochure, Should I Participate?). But to even get to that stage, a person needs to know How to Find a Clinical Trial. Some patients may think that their doctors will tell them about any trials they might be able to join, but that is not always true.

The process is not as simple as just finding a trial, though. As we explain in the brochure, there are multiple steps beyond simply finding a trial and joining. Before someone even starts looking, a patient should understand their condition to help identify which trials might be best for them.

As with anything in today’s world, looking online is a great place to start looking for a trial, so we provided three main clinical trial search sites based on location. We recommend putting together a list of trials that interest a potential participant. Then we suggest putting together a list of questions for trial staff, and then contacting them.

This is only the first step of deciding whether to join or not.


Clinical research participation is a complicated process, from thinking about joining, to figuring out if you should join, and then actual participation. We’ve created the three resources listed above to help people in all steps of the process, but we have a lot more in our Resource center that support patients, caregivers, and others across all parts of research.

One of CISCRP’s missions is to partner with patients and the public. This includes working together with patients, community members, and healthcare professionals to create our brochures, infographics, and other materials. We are always open to feedback on our materials or any other resources we should make. Feel free to contact us!

Written by: Scott Finger

A “Day in the Life” of a Medical Writer at CISCRP

It is Monday morning at the CISCRP office, and I open my computer a few minutes before 9 AM and prepare myself for a new week. I normally work from home on Mondays, but a few colleagues who also often work from home were planning to come into the office in downtown Boston today, and I wanted to join them.

As a Medical Writer, I write about clinical trials. Every clinical trial is an incredible achievement, and one that involves collaboration between experts in many areas. They also could not happen without the curiosity and bravery of clinical trial participants, and their steadfast belief in the medical breakthroughs of the future. My job is to tell the story of clinical trials in plain language, with a focus on the big picture. What happened during the trial, and why? What did we learn from the trial? What do we still need to learn?

Our mission at CISCRP is to empower people to make informed decisions about their health and about their participation in clinical research. And this mission is personal. In addition to a Medical Writer, I am also sometimes a patient. As a patient, I know first-hand that it is very difficult to access, let alone interpret the results of clinical research. While doctors and other trusted people can help, navigating the flood of health information online, in news stories, and in advertising is overwhelming. It can be tempting to tune it all out. Yet, it is vital to understand how the newest clinical research impacts our own health care, and to be able to weigh the benefits and risks of participating in clinical research. To do so, we need access to clear, accurate, and unbiased information about clinical trials.

As I ease into the day, I check the stage of each project I am working on. One of my favorite things about this job is the opportunity to learn about many different areas of clinical research through the range of projects I work on. I check my inbox and see an email from one of our editors, who has just reviewed a Plain Language Summary, or PLS, that I had previously drafted. A PLS is a summary of clinical trial results that the trial sponsors distribute to the trial participants and sometimes publish on their website. It takes me about half an hour to go through the editor’s comments in the PLS and make the necessary changes. I send it back to the editor so they can review it. If the editor decides the document is ready, they will give their approval to send it to our graphic designer. During this step, the graphic designer creates visualizations that incorporate details about the trial design and results. This helps make the information easier to read and understand.

The writers, editors, and graphic designers at CISCRP work together to maintain consistency across different summaries, avoid unnecessary jargon that might be confusing, and keep the language and visuals engaging and approachable. We have honed our craft in large part due to feedback from Review Panels on our materials. Review Panels are composed of volunteer patients, patient advocates, and members of the public who give feedback on every clinical trial communication that CISCRP works on. Review Panels continually give us ideas and suggestions for how to make our materials as clear and engaging as possible. With everything we create, the perspectives of patients are always top-of-mind.

Next on my schedule is a “kick-off” meeting with a team from the sponsor of the trial about another PLS project that is getting started. This team from the sponsor may consist of patient engagement officers, trial physicians, and statisticians, who will all help in the planning and drafting process. A Project Manager from CISCRP leads off the meeting, which involves explaining and planning the drafting process and timeline. As we move forward with drafting, the Project Manager will ensure that everyone is moving together and that the project is on time. Next, I present an outline of the PLS itself that I previously prepared for the meeting. Preparing the outline involved going through the Clinical Study Report and other source documents provided by the sponsor, familiarizing myself with the trial, and identifying key pieces of efficacy and safety data to include in the PLS. In the meeting, we discuss the outline, go over any questions, and ensure that everyone is happy with the plan for drafting.

Many of the clinical trial materials CISCRP creates are done in collaboration with, and funded by, the trial sponsors. Sponsors, which are often pharmaceutical companies, are realizing increasingly that patient engagement is important for their success. In addition, the European Union Clinical Trials Regulation Annex V will require that a PLS be written for each clinical trial done within European Union (EU) nations. The EU is also requesting plain-language Protocol Synopses to be written at the beginning of trials, which CISCRP also helps to prepare. This shift towards patient engagement and plain language communications is a positive step forward towards improving literacy about health and clinical research, and I am proud to be a part of it.

After the kick-off meeting, I write down some notes about our discussion while it is still fresh on my mind. Next, I switch gears to another PLS. Another writer drafted this one, and I will be performing quality control, or QC. Given the complexity of clinical trials and the volume of clinical trial documents, it is essential to have multiple sets of eyes reviewing the draft throughout the process. My job now will be to verify every piece of data and every detail about the study design, and to otherwise “fact-check” the document. QC is a rewarding process for all involved. I enjoy getting a “crash-course” in a specific clinical trial while performing a QC. The results and design of clinical trials can be fascinating. From the other perspective, I am always grateful to receive QC results from another writer, as it provides additional confidence that we are creating accurate and high-quality materials.

I finish the QC right at lunch time. The weather is warm, so we head outside to a nearby plaza to enjoy some lunch, get to know our new colleagues, and hear stories about each other’s weekends.

Once back inside, I decide to spend the rest of the afternoon drafting a Plain Language Summary of Publication, or PLSP. Like PLSs, PLSPs are summaries of clinical trial results. However, rather than using the lengthy documents from the trial sponsors as the source material, they use trial results that have been published in an academic journal. Like the publication it is based on, the PLSP will ultimately go through a peer review process and be published in a journal. Compared to PLSs, PLSPs are often heavier on graphics, which means they typically involve close collaboration between the writer and graphic designer. I take time during the afternoon to experiment with different ways of explaining key concepts and presenting the trial results. I use PowerPoint to make “sketches” that our graphic designer will, in turn, use as inspiration to create the visualizations. There are no government regulations to define the scope of PLSPs like there are for PLSs, which leaves more space for creativity. I enjoy this freedom, and believe it is necessary to continue improving and innovating in our work.

By 5 PM, I am happy with my progress on the PLSP draft. I pack up my laptop and say goodbye to my colleagues. I reflect on the day as I head for the elevators.

Written by: Sam Entwisle

Plain Language Protocol Synopsis 101

What is a Plain Language Protocol Synopsis (PLPS)?

A clinical study protocol (CSP) is a comprehensive document that outlines important aspects of a clinical trial including the goals of a trial, the trial design, and more. A protocol synopsis is a summary of the CSP, but it still contains highly complex scientific terms, acronyms, and processes not readily understandable to a non-expert. A protocol synopsis written in plain language that can be understood by a wider, non-expert audience can be a beneficial resource for ethics committees, site staff, and potential trial participants. 

Additionally, Annex 1, D.24 of the European Union’s Clinical Trials Regulation (EU CTR) 536/2014 outlines that for future clinical trial applications, “The protocol shall be accompanied by a synopsis of the protocol.” The specific content to be included in the protocol synopsis is further outlined in Question 5.8 of the EU CTR Questions & Answers document. Some of this information is included below as a reference (taken from version 6.4, dated February 2023).

5.8 Question: What should be included in the protocol synopsis described in Annex I, D.24 ? 238.

Answer: Sponsors should include the information below in the protocol synopsis (maximum two pages) to be submitted with the clinical trial application according to Annex I D24 … Sponsors should consider making the synopsis understandable to a layperson. 

Further specified are the nine requirements from the clinical study protocol (CSP) that must be included in this two-page protocol synopsis. These nine requirements are:

  1. Trial title
  2. Rationale
  3. Objectives
  4. Primary Endpoints
  5. Secondary Endpoints
  6. Population
  7. Trial design
  8. Interventions
  9. Risks and Benefits

CISCRP’s Health Communications team was thrilled to learn about this new type of deliverable because we specialize in, and are passionate about, creating easy-to-understand plain language documents. With the implementation of the EU CTR in January 2022, sponsors have increasingly shown interest in developing plain language protocol synopses with CISCRP to be included as part of their clinical trial applications.

When conceptualizing our version of the plain language protocol synopsis, a primary goal became to make a graphically designed template that would include all the nine required elements from the regulation, be written in plain language, and remain under the two-page limit. After we had the template, we were able to put it to work for several trials.

What We’ve Learned from Writing Plain Language Protocol Synopses

Some challenges become immediately apparent when writing a plain language protocol synopsis under the guidelines set out by EU CTR. The first challenge is the two-page limit. Especially since plain language often requires more room to explain complex terms, and health literacy best practices require ample white space.

Additionally, from a more technical standpoint, tables have proven to be an essential asset for presenting the objectives, endpoints, and trial design. A table helps improve the readability in specific scenarios such as aligning a singular objective with multiple endpoints. For trial design, having a table that outlines the different treatment arms, medications, doses, administrations, and duration serves as a great alternative to piling all that information into a paragraph.

We have also compiled a robust glossary of plain language terms from our years of experience writing and user-testing plain language summaries. When writing a PLPS, we can utilize terms from this glossary to increase efficiency when drafting and increase consistency among all plain language documents for a specific sponsor. This consistency helps patients who may read a PLPS, informed consent form, and/or a trial results summary over the course of a given trial. It also helps sponsors by speeding up the process and the amount of work needed to create these documents.

The second and more elusive challenge is that, as a new deliverable, the target audience has not yet been clearly defined. In the meantime, we are trying to give it the broadest appeal possible. We take special care to explain as much as possible for a layperson audience while still making a document that can be utilized efficiently in an industry or medical setting.  

Another tip that we recommend is utilizing graphics and color coding as much as possible. Applying colors to different treatment groups in a table can clear up what specific treatments, doses, or activities apply to that group, without adding any words. Also, using icons can increase readability and provide a visual break in an otherwise text-heavy document.

One final consideration is an optional third page glossary to define any number of the complex terms that were included in the two-page PLPS. This would not necessarily be for submission purposes but could be used by the clinical trial staff to facilitate conversations with potential patients. The PLPS has the potential to be a multi-purpose document and provide value beyond the clinical trial application process.

Should Sponsors Add a Plain Language Protocol Synopsis to Future Clinical Trial Applications?

Based on the regulation, it seems that some form of a protocol synopsis is required. As far as the plain language part, it seems some sponsors are waiting to see what others are doing and how this rule is enforced, while others are making plain language protocol synopses a priority.

Here at CISCRP, we think the more plain language, the better. We believe engaging a wider audience in the clinical research process is an important and worthwhile endeavor. So, when the time comes to start writing your protocol synopses, why not take the next step and make them as accessible as possible to all audiences?

Written by: Zack Fey


EU CTR 536/2014 Q&A p. 54-55

EU CTR 536/2014 p. 58

CISCRP’s Finding Treatments Together Brochure for LGBTQ+ Communities

Our Approach to Codeveloping an Educational Resource for the LGBTQ+ Community

When creating a brochure for diverse populations of people it’s important to consider an expansive definition of diversity that includes, but is not limited to, ethnic and racial identity. In this case, our intended audience included Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual people (LGBTQ+), in addition to all other sexual orientations, gender identities, and gender expressions. Given that sexual identity intersects with every other form of identity, we had to take particular care to ensure that the diverse perspectives of this community were represented in the brochure. In practice, that meant acknowledging and giving space for people to speak about the many identities they inhabit and how those other identities inform their LGBTQ+ experiences.

Our discussions with subject matter experts and members of the public from the LGBTQ+ community also showed us that it was most important to give members of this community the tools they needed to navigate clinical trials in a such way that gave them agency and outlined the initial steps for making change by participating in advocacy groups and as members of the public on ethics committees.

Once we incorporated feedback from the aforementioned SMEs and community members, we tested the brochure with a survey sent to 500 members of the LGBTQ+ community to ensure that the brochure was culturally competent, neutral, and informative. This process helped make sure the topics, language, images, and design are appropriate and engaging. We also received feedback on how effective our brochure was for raising awareness about the importance of LGBTQ+ participation in clinical research.

Key Insights We Learned About Including LGBTQ+ People in Clinical Research

Respondents emphasized that the onus for navigating clinical trials as a member of the LGBTQ+ should be shared: researchers must acknowledge that the determinants of health and the ability to participate in clinical research are multidimensional. For example, one’s lived experience, geographic location, ability to access health services and procedures are also important variables when considering how to make treatments safe and effective for everyone.

To that end, this brochure was created to raise awareness about clinical trials and to identify the barriers to inclusion, and the potential concerns members of the LGBTQ+ community may have with participation in clinical trials. To do this well, we had to consider how history, culture, and even current events may structure a group’s perception of clinical trials. Our initial research with SMEs and community advocates brought up historical wrongs, such as the US federal government’s hostility towards HIV/AIDS research, that have left enduring legacies of mistrust and suspicion towards clinical trials. However, the source of this mistrust isn’t confined to the past: many of our conversations with SMEs centered on current legislation at the state level that targets trans and non-binary people by denying them necessary medical care has likely had a chilling effect on their seeking medical care or clinical trials.

When we spoke about these issues to members of the LGBTQ+ community we received critical feedback that raising awareness was important but insufficient. In order to develop the most helpful version of this brochure, we were asked to highlight the ways in which the lack of action from researchers to be more inclusive negatively impacted access to care, willingness to participate, and the overall experience of participation for those who did partake. They advocated for switching the narrative from one that asked LGBTQ+ people to navigate the pitfalls of clinical trials, to one that also put the onus on researchers to accommodate their needs. Reviewers emphasized that this approach moved the onus of accommodation from participants to researchers.

Next Steps Towards LGBTQ+ Inclusion in Clinical Research

However, there is so much more work to be done. Collaborating with LGBTQ+ communities to raise awareness about representation and inclusion of LGBTQ+ people in clinical research must be an ongoing efforts in all spheres of the clinical research industry, as conditions are continuously changing. In practice, these efforts would include  outreach, awareness, and empowerment of the communities with education and resources to help them participate in their own advocacy.  In addition to empowering participants, researchers must initiate their own educations to ensure they are adopting more inclusive practices.


It gives me great pleasure to share my testimony on working with the Center for Information & Study on Clinical Research Participation (CISCRP) for a number of years; most recently on their LGBTQ+ brochure project, the development of which I had the incredible privilege of being a small part of. From its very inception, it was clear that this was not just ‘another brochure,’ but a meaningful step towards addressing the long-standing gaps in clinical trial participation and research among the LGBTQ+ community. The journey towards crafting CISCRP’s comprehensive and inclusive resource once again demonstrates not only their ongoing, deep commitment to highlighting the urgent need for further work to ensure genuine inclusion but also to further explore the unique challenges faced by some of the most under-resourced populations in the realm of clinical trials.

The development process, as is always the hallmark of the CISCRP team, was again marked by unwavering dedication, collaborative effort, and an unyielding commitment to authenticity. We had the pleasure and privilege of engaging with community members, medical professionals, and LGBTQ+ advocacy organizations to ensure that every aspect of the brochure resonated with the lived experiences of those for whom it was designed to serve.

This brochure is a tool – a catalyst for change – that has the potential to spark meaningful conversations, challenge preconceptions, and drive research policy reforms. I heartily commend the CISCRP team for recognizing the importance of inclusivity and continuing their critical work to dismantle stigmas, advocate for change, and ensure representation among all individuals at the table – and to empower communities to actively shape the future of clinical research. My journey in helping to develop the LGBTQ+ brochure for CISCRP has been an experience of profound learning, empathy, and hope, and one that reinforces the fact that progress is made through collaboration, compassion, and a relentless pursuit of equality.

This is an endeavor to celebrate, though we must remember that the path ahead is still quite long. I have every confidence that the CISCRP team’s dedication in ensuring every voice is heard, every story is valued, and every individual is embraced within the scientific arena will be resolute. I commend them on, and deeply appreciate, their quest for engaged representation and inclusivity in clinical trials for all. It is a true honor to work with this team and contribute to their meaningful efforts as THE leader in patient engagement, clinical research education, and clinical trial research and participation.

Heather C. Guidone, BCPA, Surgical Program Director  
The Center for Endometriosis Care

The Importance of Transgender and Non-Binary Inclusion in Clinical Research

Recapping the webinar in collaboration with Clario

At CISCRP, we value the importance of engaging and informing the groups that are underrepresented in clinical trials. One of these underrepresented groups is the LGBTQ+ community. Earlier this year, we published an educational brochure as a part of our Finding Treatments Together series for the LGBTQ+ community. This brochure  features topics about why LGBTQ+ volunteers are needed and how they are protected, along with providing resources on where they can go to get more information and sign up for trials.

On June 27, 2023, CISCRP partnered with Clario to host a webinar called “Working Towards a More Inclusive Environment: Transgender & Non-Binary Participants in Clinical Research.” June is Pride Month in the United States, so we thought it appropriate to have an important discussion related to LGBTQ+ topics. With a similar goal in mind, Clario approached CISCRP with the idea for a webinar project to highlight the clinical trial and healthcare experiences of the transgender and non-binary communities. The LGBTQ+ community is vast and inclusive of different sexual orientation and gender expression groups, and each of these groups have their own unique sets of challenges they encounter. For this reason, it is important to engage with each of these groups to understand their experiences.

Jae Bailey (They/Them)

Liam Paschall (He/Him)

To better understand how best to engage with members of this community, we teamed up with 2 members of the transgender and non-binary community to facilitate the webinar. Our facilitators were Liam Paschall (he/him) and Jae Bailey (they/them). Liam is a transgender man who is a consultant and public speaker who advocates for the LGBTQ+ community in efforts to create a more inclusive environment in healthcare. Jae Bailey, a non-binary artist, model, and activist, works in the clinical field and is passionate about being a voice for the LGBTQ+ community, especially within the clinical field.

 “Including transgender and non-binary people in clinical trials is crucial for equitable healthcare,” Liam said. “By including trans and non-binary people, we can enhance the understanding of how treatments affect different populations, leading to more effective and tailored healthcare for all individuals. Participating in the recent CISCRP/Clario webinar was an empowering experience. It provided an opportunity to share personal insights and challenges faced by transgender and non-binary people, advocate for improved representation, and promote better healthcare outcomes. It was a chance to foster understanding, challenge biases, and contribute to positive change in clinical research and healthcare.”

Hearing firsthand from people who are subject matter experts in their lived experience helps bring about the changes that are needed. We at CISCRP were thrilled to collaborate with Clario to organize this webinar. “There is a huge difference between knowing and feeling,” said Rosie Woolley (she/they), LGBTQ+ ERG Co-Chair at Clario. “We know there is inequality. It’s why we and CISCRP do the incredibly important work we do. However, hearing the experience of a person undergoing medical treatment and how their gender identity was not recognized made it all real again. We get caught up in statistics but moments like this make these challenges human again. Hearing one of the speakers want to ‘leap from the [operating] table’ was incredibly emotive. It’s recognizing his fear, his doubt, and his pain. Vulnerable sessions like these are what inspire people to act. The whole presentation was an excellent tour of the topic; taking people from base understanding through to the impact in clinical trials and how they can help. I would deeply recommend.”

A few major takeaways from the webinar were the steps Liam and Jae listed on what we, as a society, can do to ensure fair and equitable treatment of transgender and non-binary people in healthcare and clinical research. These include:

  • A deliberate culture shift and goal setting, such as diversity, equity, and inclusion (DEI) training for all researchers and site staff.
  • Partnership and collaboration to include transgender and non-binary community members on advisory boards, or to make adjustments to protocols, ICFs, and data collection forms. This could be as simple as including “transgender man/woman” and “non-binary” as gender options on an intake form.
  • Outreach and community engagement to improve conversations and partnerships between industry and the communities.
  • Inclusive environments, which include the use of gender-neutral language, using chosen names and pronouns, and fostering a compassionate and nonjudgmental environment.

These are just a few examples of  ways to be more inclusive of transgender and non-binary people. However, there is much work to be done. It’s not only the responsibility of healthcare workers and researchers to take action, but we, as a society, can also take steps to create a more inclusive environment for these communities. Also, these 2 groups are just a portion of the greater LGBTQ+ community. We need to think of what we can do for other community members and how to foster a more inclusive environment for all. Our work doesn’t stop here; this is just the beginning.

Written by: Zarin Tasnim


For more actions and insights, watch the full webinar here. 

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.



Behind the Scenes of Health Literacy at the Movies

In October, CISCRP’s Health Literacy team worked with a Top 25 pharmaceutical company, to create an infographic celebrating Health Literacy Month, marking the second year of this collaboration. Last year’s materials included an infographic with tips for implementing health literacy best practices and a health literacy crossword puzzle. This year’s infographic contains an exercise to help readers brush up on their health literacy knowledge and think about the importance of keeping health literacy front-of-mind.

CISCRP creates many materials designed to improve health literacy, including videos and brochures. While the general education these provide is important, it is also important to understand the concepts behind their creation. In these Health Literacy Month materials, we unpack what health literacy means, how health literacy principles can be put into practice, and who is responsible for facilitating health literacy. Stay tuned for a look behind the scenes at the concepts highlighted in this infographic.

The theme of the infographic is health literacy at the movies. Health literacy issues appear even where we may not think to look for them, like in our favorite movies. For this Health Literacy Month, we challenged readers to notice and consider how health literacy is depicted in their favorite entertainment media.

Why health literacy at the movies?

Films are a great way to engage with health literacy because of the emotional connections created through storytelling. The empathy we feel for characters allows us to engage with health literacy issues more deeply. The separation of the screen provides us with a safe environment to experience health literacy issues along with the characters, while also giving us the opportunity to step back and look at the big picture.

What is health literacy?

It’s important to remember that health literacy has two dimensions: personal and organizational.

Personal health literacy is 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.

Organizational health literacy is the degree to which organizations equitably enable individuals to find, understand, and use information and services to inform health-related decisions and actions for themselves and others.  

In this infographic, we used movies to offer a bird’s-eye view of the intersection between personal and organizational health literacy in the lives of characters onscreen. This infographic focuses on a few key concepts related to health literacy: decision making, organizational health literacy, and health equity. Each of these concepts is the focus of a different part of the exercise, chosen to encourage health professionals to think about health literacy as a shared responsibility between individuals and organizations.

Let’s start the show!

For this exercise, readers are asked to pick a health literacy issue faced by a character in any movie , whether it is part of the main plot or a small moment. We encourage the audience to engage with health literacy through the entertainment that is interesting to them, whether that means identifying an issue faced by an action hero, sitcom character, or dramatic lead. We designed this exercise to work for any situation, from a character’s cancer treatment to an accidental injury or misuse of medication.

In the first part of this exercise, we highlighted the ability to use information and services to make health-related decisions. Conversations about health literacy often focus on readability and understanding, but the ability to use information and services to make decisions is just as important.

The second part of this exercise asks readers to think about whether the narrative they’ve chosen acknowledges the impact of both personal and organizational health literacy. It was especially important to spotlight organizational health literacy for industry professionals, to get them thinking about the many different stakeholders that play a part in improving personal health literacy for individuals.

In the third part of this exercise, we highlighted health equity and the social determinants of health. The concept of health equity is necessary for understanding the intersection between personal and organizational health literacy. In order for organizations to facilitate personal health literacy, there must be acknowledgement and understanding of varying needs and barriers across different communities. Efforts to improve health literacy are not benefitted by a one-size-fits-all approach but rather by strategies that improve access and opportunities to those who need it most.

Adding some movie magic

The Health Literacy team at CISCRP enjoyed thinking creatively about how to engage a professional audience in this health literacy exercise. One of the most enjoyable parts of the development process was incorporating movie theater imagery into the visual design to draw the audience in. We particularly enjoyed the creation of a health literacy superhero and the visual pun evoking 3D movie glasses that we used to introduce the two dimensions of health literacy. These elements are not just about having fun, but also about organizing content into digestible chunks, an important step for supporting health literacy.

Here’s a word from the Senior Director of the pharmaceutical company with their thoughts on Health Literacy at the Movies:

We were delighted to work with CISCRP to create materials for Health Literacy Month. We partnered with CISCRP because of their expertise in health literacy education, their creative approach, and their experience in tailoring materials to specific audiences. Our pharma company is dedicated to supporting health literacy education and awareness throughout our organization, and we look forward to continuing this partnership with future educational materials.

At CISCRP, it is always our goal to create materials that encourage education. We designed this health literacy refresher to get health professionals to think about health literacy in new ways, both by encouraging them to notice the influences of health literacy all around them and to think about the intersection of personal and organizational health literacy. In this way, the next time they’re at the movies or even catching up on their favorite show, they might think about their organization’s role in health literacy, health equity, and individuals’ agency—not only that of their favorite characters, but of people in our world, too.

Written by: Nina Treese

View Full Infographic Here

How CISCRP Made Tools for Informed Decision Making

Guiding Informed Decisions

It’s an all too familiar story – a patient receives a new diagnosis of a rare disorder. But now, they are told that there is a clinical trial option available. However, their lack of knowledge about clinical trials concerns them. In another case, a pediatric patient receives a new diagnosis and is offered an opportunity to participate in a clinical trial. Similarly in this case, the parents or caregivers of this child are not familiar with clinical trials. An important decision needs to be made in both scenarios.

Unlike the scenarios described above, most Americans have never faced a personal decision about whether to participate in a clinical trial. Of those who are invited, less than half choose to participate. There can be many reasons for this; the choice to participate or not is deeply personal. It means thinking about things like finances, family, current and past social injustices, and values, among other things.

Well before the need arises to access trial treatments, people should learn about the clinical research process, how to partner with researchers generally, and what it means to participate in trials. Even after learning about trials by reading brochures, and watching videos for adults or children, the process of making a decision may remain unclear. Making this kind of “informed decision” — one that looks at a complex decision from all angles — is hard under the best circumstances. When the choice involves personal health, or the health of a loved one, it can feel overwhelming. So, the team at CISCRP has developed brochures to address questions about clinical research and help guide the decisions of potential clinical trial participants. More examples of stories and articles can be found here, here, here, here, and here.

Developing the Brochures

CISCRP’s Health Literacy Team thought a lot about what goes into the decision to take part in a clinical trial — and what tools can help make the decision process easier — when we developed 2 new educational brochures on the topic.

The first brochure, titled “Should I Participate in a Clinical Trial?”, is for people weighing the pros and cons of taking part in a clinical trial. It includes questions that people may want to consider asking themselves, a healthcare professional, and trusted family and friends before making a decision. The brochure also serves as a resource for healthcare providers, community and faith leaders, family members, and anyone else helping potential trial participants navigate this process.

The second brochure, titled “Should My Child Participate in a Clinical Trial?”, is designed to help parents and caregivers of children who have been asked to join a pediatric clinical trial. As we wrote in a recent blog post, children have different healthcare needs and rights than adults, including different rights to make medical decisions. Parents and caregivers are tasked with making big decisions (like ones about trial participation) on their child’s behalf. Sometimes, a child might agree to join a clinical trial, but a parent or caregiver is still undecided. This means having to consider multiple perspectives at once.

The Importance of Empowering Patients as Health Literacy Professionals

As health literacy professionals, our goal with both projects was to improve the ability of individuals to find, understand, and use information and services to make health-related decisions. We emphasize this point because all materials we create, including these brochures, are planned with care to be non-promotional and unbiased. The brochures share user-friendly information to help participants, potential participants, and the public make the decisions that are best for them, and that benefit everyone and help improve the research process.

In these brochures, we aimed to address the unanswered questions people may have: What does it mean to be in a clinical trial? What does it mean to “weigh risks and benefits”? And how can I make sense of all the information coming my way?

Providing cognitive tools and points to consider helps guide the decision-making process, making it a more empowering and less overwhelming process. Additionally, we worked with patients, advocates, and subject matter experts (SMEs), who reviewed and provided input on both brochures. This helped us ensure the appropriate information and tools were included.


Our hope with these educational brochures is to not only empower patients or caregivers to make informed decisions, but also encourage providers and study teams to start open conversations with potential participants to help make decisions. And, we welcome conversations about other tools and information that could help patients during the clinical research process. How else can we empower patients and the public to make more informed decisions and partner with the research community to improve clinical trials?

DEI Series — Educating Clinical Research Practitioners Through Video

Recently, CISCRP partnered with WCG to create a video for researchers and study staff that emphasizes the importance of diversity in clinical trials. In addition to educating the public, raising awareness among research professionals about the importance of Diversity, Equity, and Inclusivity (DEI) is critical to increasing cultural competence and understanding of participants’ needs.

You may have read our post about how videos are becoming a key tool of health literacy, and how clinical research could benefit from more videos communicating information in an accessible way. In this post, we dive into our creative process for producing a video with that objective in mind.

We were delighted to collaborate with WCG on this video. WCG partnered with CISCRP to produce this video because of our expertise in educating the public and clinical research professionals about the importance of diversity in clinical research. Like CISCRP, WCG is committed to helping ensure that the public gets the most effective and safe treatment possible. 

Because of that urgent need, WCG were very excited to work with CISCRP on addressing this topic. We know this engaging video collaboration will help energize researchers, and especially site staff, to bring more diversity into their trials.

To see the video, click here.

Research and Creative Planning

As with any complex project, whether you’re writing a novel or baking a cake, it’s important to plan every step in advance. However, for this project, assessing our audience’s needs, perceptions, and general level of cultural competency would determine how we structured the tasks ahead – so we started there.

The purpose of this video was simple: to encourage clinical research professionals to take tangible actions to ensure their trials had diverse populations. Given our experience developing educational materials on diversity in clinical research by collaborating with patients, their communities, and the public to understand their concerns and needs, we knew the key messages researchers needed to see and hear. Delivering that message in a way that will have an impact was the challenge.

Clinical research professionals may already know about the importance of diversity in clinical research and may even know about the available tools and practices to improve their trial’s diversity. So, how could we convince them to make more of an effort to invest in and implement these tools and practices?

We certainly didn’t want to bore them with information they already knew. Instead, we decided to focus on an impactful narrative to give them that extra push and reinvigorated perspective. And we had to do it in under 3 minutes.


We decided on an animated video that portrayed a realistic scenario: patients from a diverse background whose prescribed treatments were not as effective or tolerable as demonstrated in the less diverse study populations during clinical trials. The storyline focuses on one patient to begin with, then shifts to a larger patient population who all realize that the clinical trials for the treatment they needed did not include patients from their respective communities.

As each patient asks their doctor some tough questions, treatments disappear from the shelves of the pharmacy shown in the animation:

“Could my race affect how this drug works?”

“Was the drug tested on women like me?”

“Could my weight be why this drug didn’t work?”

Then in the final scene of this part of the video, the problem is summed up by a disappointed patient:

“I think I understand. They didn’t test this for people like us.”

After the scenario, the narrator addresses this problem directly to the audience. It was important that the messages were not received as a critique of researchers—as we say in the video, there’s already so much good work they’re doing. Rather, we wanted to bring this subject to the top of their minds and say that by taking steps to ensure diversity in their trials, we can avoid situations like the one they just watched.

The script went through several drafts which included reviews from CISCRP’s team, our WCG collaborators, and subject matter experts on DEI in clinical research.  Each round of feedback included more voices and perspectives from folks in the clinical research world. As a result, each draft became more engaging, appropriate, and relatable to our intended audience.

For example, the original plan was to follow one patient. In the final script, we decided to combine the stories of five diverse participants. Then we realized that our characters’ names were not diverse. At first, they were named common names, which likely wouldn’t represent the diverse groups that are underrepresented in clinical research. We also ensured we represented the doctor, a “Dr. Smith,” from a white man to a black woman.

Key Learnings

In early drafts of the video animations, while the characters had different skin tones, they didn’t have other aspects that represented diversity. Something important we all have to keep in mind is that diversity comes in many different forms—from some of the more obvious things, like race, ethnicity, sex, and gender, to more specific details like health conditions, weight, and even lifestyle. So, we made a few subtle tweaks to represent diverse bodies, appearances, and cultural appearances.

Also, in choosing the voice-over actor, we settled on someone who represented a diverse population to add credibility to the messaging.

Some of the considerations went beyond diversity. We wanted our video to feel real, because the scenario we crafted is something that unfortunately happens too often. Given the prevalence of this issue, we also wanted the video to demonstrate sensitivity towards the difficult situations participants often face.

For example, in early drafts of the video, the doctor was smiling throughout, even as she learned that her patients were suffering. Not only is this not realistic, it appeared insensitive and even offensive. Still, we had to find the balance between making character emotion powerful while making sure they didn’t act like children’s cartoon characters.

Finally, once we were done tweaking the thematic elements of the video, we polished the presentation to a fine, professional gloss. Over the course of three drafts, spread out over weeks of review, we gave feedback on the timing of edits, the tone and speed of the voice actors through specific sections, and the subtle connotations of the animated characters’ movements. All of this was to ensure that this video was produced to the highest standards.

Never call it a day

As we’ve mentioned in other posts, the health literacy process does not stop here. We want to learn how effective this video is, and what we can do to improve our communication and education in future projects. Whether we’re making content for a professional audience or for the general public, the insights we gain on any given project accumulate and inform the production of future projects.

Written by Scott Finger, Senior Editor – Health Literacy, CISCRP

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.

Volunteer opportunities with CISCRP, visit our Volunteer page

No “Kidding”: Using Health Literacy to Communicate Clearly About Pediatric Trials

Written by: Holly Arthur

In a recent post, CISCRP’s Health Literacy team discussed why it’s important to make information about clinical trials clear for everyone. We consider a lot of things when creating materials — like brochures or videos — depending on the audience. For example, we’ve been developing brochures for people from different racial and ethnic groups about the importance of diversity and representation in clinical trials. With these projects, we’ve looked at how language, culture, personal values, and history shape people’s decisions about participation. A main goal of these projects is to connect with people who don’t always have access to information about clinical trials that is both relatable and easy to understand.

But what if your “audience” includes almost a quarter of the population of the United States, yet doesn’t include anyone legally allowed to make all their own medical decisions? Recently, the Health Literacy Team has been expanding a key part of CISCRP’s mission — “education before participation” — to a new generation. We have been working on projects to help kids, families, and their healthcare providers navigate decisions about clinical trial participation together. We’re excited to tell you about some of these projects today, and to share a few of the challenges — and accomplishments (!) — we’ve encountered so far.


Not just short adults

It may seem funny to think of children as an underrepresented group, but among clinical trial participants, they are. Just like there isn’t enough gender, racial, or ethnic diversity among trial participants, the number of registered pediatric clinical trials doesn’t reflect the number of children who depend on trials for new, safer treatments.

As the saying goes, kids aren’t just small adults. Children’s bodies may respond differently to treatments than adults’, even if it’s the same treatment for the same condition. And too often, treatments prescribed to children have only been tested in adults. Pediatric trials help us make sure that treatments children receive are safe and effective for them.

 Of course, the differences between kids and adults aren’t just physical! As they get older, people go through changes in how they think, learn, and relate to others. Even an infant and a toddler only a year apart, for example, have different abilities, interests, and needs. So do a 10- and a 16-year-old. Creating materials for pediatric participants means thinking about all kinds of age-related differences that have a big impact on health literacy.

Children also don’t have the right to sign legal documents, in most cases. This includes documents agreeing to participate in clinical trials, also called “informed consent forms.”  A parent or guardian must give permission, called “consent,” for their child to participate. Children old enough to understand what being in a trial involves are asked to give their “assent,” or agreement. This is not a substitute for a parent or guardian’s consent, but a child can refuse to give assent after learning about a trial, so it’s important to share information in a way that is age-appropriate.

What is the Health Literacy Team Doing?


Pediatric Video Project

Earlier this year, we launched our 4-part Pediatric Education Video Series, created specifically for children and their caregivers. The live-action videos were developed with help from various community members — most importantly, kids — to provide an age-appropriate overview of clinical trials. As health literacy experts, explaining ideas like “informed consent” or “placebo” so the average person can understand them is our bread and butter. Still, explaining these things to kids at all different ages and stages really forced us to up our game! The actors in the videos do a great job of making new information feel safe and not (too) scary for viewers. Check out the videos on our website  or YouTube page.


Updated Brochure for Parents and Guardians

We are wrapping up a complete rewrite and redesign of our brochure on pediatric trial participation, “Should My Child Participate in a Clinical Trial?” This is one of many brochures on clinical trial participation you’ll find in CISCRP’s online education center. Like all our educational materials, the creation process was guided by insights from the CISCRP community. We listened to parents, guardians, professionals, and other experts to understand what matters most to them. What do real parents of past pediatric clinical trial participants, or potential clinical trial participants, think is most important for others to know? What information do professionals who work with pediatric participants and their families wish those families had more access to?

We heard your feedback that caring for a child with a medical condition is stressful for the whole family. Parents need empathy and support when making difficult decisions about their child’s health. We also heard your feedback that it’s important to discuss clinical trial participation with children, even though it can be a tricky subject. We used these insights to shape the content of the new brochure. Our health literacy experts worked closely with our in-house Medical Writing team to make sure this important subject hit all the right notes. The new brochure will be available soon on CISCRP’s website and for purchase in our online store. (Want more information? Contact Lucas Goren at


Pediatric Plain Language Summary

One of CISCRP’s signature programs is our communicating Trial Results Summaries service. All participants have the right to receive results of the study they helped make possible, written in language that makes sense to them. However, information written for and by researchers is not always clear or friendly for non-scientists. This is why CISCRP works with study sponsors to create hundreds of plain language summaries of trial results every year.

But what about pediatric trials? As it turns out, creating kid-friendly, age-appropriate plain language summaries of pediatric trial results isn’t the norm. This is partly due to lack of regulation, or unclear regulations, about sharing pediatric trial results. Because this is new territory compared to creating adult trial summaries, experts (like CISCRP) are still developing and testing best practices.

We can’t wait to share details from our first-ever pediatric plain language clinical trial results summary. It’s not ready to “go live” just yet, but we can tell you a little about what it includes. For starters, we focused on using a narrative, or story, to talk about the process of being in a pediatric clinical trial from start to finish. The summary tells the story of a character who participated in a pediatric trial as she learns about the results and reflects on being a participant. We hope this “picture-book” style helps make complicated information approachable and engaging for kids, and we’re excited to get some feedback from real-life pediatric trial participants down the road.


Consent and Assent Forms

Informed consent forms (ICFs) and assent forms can be hard to understand. But it’s very important that potential participants, and parents of participants, understand what these forms say. Knowing what a trial involves, and what the risks and benefits are, is critical for making an informed decision. 

CISCRP recently worked with a sponsor company, parents, advocates, and other experts to create clear, engaging informed consent and assent forms that support health literacy. These will be shared with potential participants in a pediatric study starting soon. This project came with some challenges and some creative solutions. For example, we decided the materials should feature an animal character. But consent and assent forms need to be balanced, not biased, about possible risks and benefits of joining a study. How do you make sure a cartoon animal looks thoughtful, but not scared? Or proud, but not boastful? How do you write about risk honestly and in a way children will understand, without causing unnecessary fear because risk is a hard thing to explain, even to adults?

The balance between information and neutrality is tricky, so we had a lot to think about! But in the end, we are thrilled with how the project came out. We hope to work on more projects like this — and other new projects for pediatric participants — soon.

Want to help us create, test, and improve new materials like these? We depend on your feedback. Learn more about volunteering and how you can sign up today.

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.