Results from CISCRP’s 2023 Perception & Insights Study

CISCRP’s Perceptions & Insights Study routinely assesses global trends in attitudes, perceptions, and experiences associated with clinical research among patients and the public. The results from our latest 2023 study are in, with over 12,000 responses from around the world! We discuss the latest findings from this study during the webinar.

Featured Speakers

Annick de Bruin

Chief Research and Insights Officer, Research Services, CISCRP

Rebecca Nordland

Senior Project Manager, Research Services, CISCRP

headshot_Emily Clifford

Emily Clifford

Senior Project Manager, Research Services, CISCRP

Jackie Zimmermann MS Advocate

Jackie Zimmerman

MS & IBD Patient Leader


Twyla Bode RN BSN MN

Clinical Research Nurse Coordinator

Highlights From the 2023 Study Include:

  • Public understanding of clinical research and perceptions of safety increased post-pandemic
  • Top mentions for increasing trust in pharma companies conducting trials:
    • By the company sharing information about the health risks and benefits of their medicines
    • Knowing that the company actively works with patients, caregivers, and patient communities to make clinical research studies easier to participate in
    • By the company sharing information in patient-friendly language that they can easily understand
  • About half were ‘very willing’ to go to a pharmacy for study visits, however those who were not willing were most concerned:
    • About the facilities (i.e., too public, lack of a private room/area)
    • That their privacy/confidentiality would not be protected, and
    • About the quality of care they would receive

Community Trust: The Foundation for Fostering Diversity in Clinical Trials

Featured Article in our October 2023 Patient Diversity Campaign

As an industry, we must recognize and address a complex problem: racial and ethnic minority populations have historically been underrepresented in clinical trials. Over time, it has become widely recognized that this issue is a systemic problem, not a participant one.

What does that mean? It means there have been limitations in clinical research that aren’t isolated, but deeply embedded in our processes and systems. These limitations can include anything from protocol complexity to a lack of diversity in the clinical research field, which can create barriers to ensuring participation. This can have long-term implications for equitable access to medicines.

We’re making progress. In the past few years, Merck has increased participant diversity in our trials. Much of our progress is thanks to our community collaborators, whose engagement is vital in helping us understand and solve the complex issues at play.

Written by: LaShanda Gordon

Defining community collaborations

For me, community is synonymous with home. I grew up in Selma, Alabama. Many consider it the seat of the Civil Rights movement, but it is also the small southern town that taught me the power and importance of community.

At Merck, I’m a Diversity Program Lead for Clinical Trials, and part of my job is working directly with community-based organizations and leaders to provide valuable resources about clinical research. I also help our company and communities make connections to try to improve trial access. An important step for increasing clinical trial participant diversity is helping to ensure everyone can make informed decisions about their health, no matter who they are or where they live. That starts with education.

Over my years in the industry, I’ve learned something valuable from every person, project, and community. Some of my takeaways include:

  • Learning never ends. Every engagement helps improve our understanding of how an organization operates, the unique needs of a particular community, or what approach would be most impactful. We need to listen.
  • Start with the community-based organizations. They are the most knowledgeable about what their community needs. In addition, they are connectors and can be a bridge to valuable resources, insights, and additional partners.
  • Each community is unique, with its own set of challenges and strengths. For example, the needs of an African American community in the Bronx are different from one in rural Alabama – we cannot retrofit strategies from one to the next. It is important to listen and learn about the particular needs of the community.

Building trust

Being a good collaborator starts with trust. Without that, we can’t build a path forward. It’s the foundation to everything else, but it can be the hardest part to get right.

I’ve found the best way to earn trust is by listening. We want to ensure our partners feel heard – especially because we use insights from them to build our approach. It’s also important to ensure we’re not guided by preconceived ideas about what they need. If you ask what needs to be done, the community will tell you.

At Merck, we recently established a U.S. Community Advisory Panel, with patients, caregivers, health care providers, and community members from diverse backgrounds who – along with our existing Patient Advisory Panel – share insights that help us incorporate the patient perspective in our site and patient engagement methods. We listen to them, and we learn a lot.

The best part is that we are seeking their guidance early, when it can have the greatest impact. For example, they are helping us design our protocols to be patient-friendly by reviewing the number of in-person site visits and inclusion/exclusion criteria for trials. That way, we’re able to address potential barriers as early as possible in the process.

Putting people back into collaborations

Too often, we forget that collaborations are about relationships, and those are built between people who trust each other. People are also the focus of our trials.

When we make our efforts more about people, we must also think bigger than trials and focus on wraparound care like disease education and screenings. There are still many who are not aware that they may be eligible for a clinical trial. It’s important that we prioritize education and awareness, long before there is a study to enroll in.
We can only earn trust as a collaborator in the continuum of a community’s health care. Our support can’t be exclusive to one-off projects. We must be present and active in what we help build.
Most importantly, we must remember the thread that runs through it all, the real definition of the word community: people.

Authored by: LaShanda Gordon

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

Insights on Developing an Impactful DEI Video

Hear from our panelists who share insights gained while developing CISCRP’s video, The Importance of Diversity in Clinical Trials. The discussion will focus on how to embed key DEI principles and concepts, not only in the product but also in the process, ensuring a balance is struck between nonpromotional education and advocating for participation, logistical tips for planning and executing a successful live-action video project.

Featured Speakers

Lucas Goren

Senior Project Manager, CISCRP

Behtash Bahador

Director, Health Literacy, CISCRP

Tammy Wilkins

Tammy Wilkins

Senior Manager, Applied Innovation and Process Improvement, Otsuka


Matt Low

Chief Creative Officer, Praxis Communications

Mel Hardman

Dr. Melissa Hardman, MPH, MS

Faces of Research


Ashley Nealy

COVID-19 Clinical Trial Participant


Melvin Mann

Video Participant