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.

Conclusion

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

References:

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

EU CTR 536/2014 p. 58

https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en

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.

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/

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 >

The Importance of Patient Engagement and its Role in Clinical Trials

Life is full of decisions. From the moment we wake up until the moment we go to bed, we make decisions. About what we wear, what we eat, the next show to binge.

What about the decisions we make about our health? Do we make the decision to exercise regularly? Do we decide to drink water instead of another cup of coffee? Making informed decisions when it comes to our healthcare can be overwhelming, which is why patient engagement is so important. Studies have shown that when patients are more actively involved in their healthcare, they experience better health outcomes.

Patient engagement relies on the interaction between healthcare providers, caregivers, and patients to make good healthcare decisions on behalf of the patient. Ultimately, it’s up to the patient to take this information and make an informed decision about their care. An informed decision involves the patient taking all the information related to their care, weighing the benefits and risks, and making the best choice for themselves. But how do patients cut through the medical jargon to understand what’s being said?

This is where plain language (sometimes called “lay language”) comes in. Lay language is a way to communicate with patients in a way they can understand so they can make informed decisions about what’s best for themselves and their families.

Perhaps one of the most important informed decisions a person can make about their health is whether or not to participate in a clinical trial. With a growing demand for participants to enroll in clinical trials, the need for patient engagement—and more importantly, plain language—comes into play.

Coupled with patient engagement is a growing demand for plain language materials that help readers understand the importance of making informed healthcare decisions. CISCRP is a clinical research education company dedicated to producing high quality plain language patient engagement materials aimed at helping participants make informed decisions on their health.

Offering a wide variety of services, from trial results summaries to a range of educational brochures, CISCRP leads the charge in effective, easy-to-understand patient engagement materials. While many sponsors understand and believe in the importance of patient engagement—more specifically, providing trial results. A 2019 perceptions and insight study found that 61% of participants did not receive any reports on the results of their trial. Partnering with sponsors, and under guidance from the EU CTR, CISCRP has been able to provide thousands of plain language summaries of trial results for over 15 years, giving back to participants the results of their trial in language they can understand. These summaries are a critical aspect of helping patients take an active role in their healthcare. By helping them understand the trial they participated in and its outcome, participants are empowered to make better decisions going forward.

CISCRP is a committed leader of empowering participants to make informed decisions about their health. Learn more about CISCRP’s mission and services here.

Written by: Jacqueline Ruzicka

References:

“Health Policy Brief: Patient Engagement,” Health Affairs, February 14, 2013.

“Why Patient Engagement Is Important In Healthcare,” Sequence Health, April 7, 2020.

The Center for Information and Study on Clinical Research Participation. ciscrp.org

“CISCRP’S 2019 Perceptions and Insights Study.” CISCRP, 30 Sept. 2019, www.ciscrp.org/ciscrps-2019-perceptions-and-insights-study/. Accessed 5 Apr. 2023.

What is a Placebo?

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 what placebos are, and why they are used in clinical trials. 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 is a Placebo?
  • Why are Placebos Used in Clinical Trials?
  • How Placebos are Used in Clinical Trials
  • Will Participants Receive a Placebo
  • Are Participants Told if They Receive a Placebo

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

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