A new form of health communication: Plain Language Summaries of Publications

Written by Kim Edwards | kedwards@ciscrp.org

New to CISCRP’s service offerings is the development of Plain Language Summaries of Publicationsalso called PLSPs. Using the same best practices that we apply to trial results summaries, we translate an original scientific article into easy-to-understand language and graphics. Together with Oxford PharmaGenesisa global provider ofmedical,regulatory,andscientific writing, we are excited to be involved in the creation of several PLSPs. These PLSPs may be a resource for patients and the public, patient advocacy groups, and non-specialist clinicians with little time. 

Each PLSP that CISCRP creates is reviewed by an editorial panel made up of patients, professionals, patient advocates, and members of the public. These volunteers provide valuable feedback to help us make sure that the PLSP is educational, clear, and complete. 

PLSPs can be published as standalone articles or alongside the original scientific article. They can be provided through a sponsor’s website, patient advocacy websites, direct mail campaigns, and webinars. While PLSPs are a new and developing form of health communication, CISCRP’s established skillset allows us to meet the increasing demand for PLSPs. Amedia and public attention around medical research and clinical trials continues to growthe value of PLSPs is clearNow more than ever, it is important that everyone has access to easy-to-understand scientific and medical information. 

We invite you to read this PLSP we createdIt was recently published in Future Oncology and translates results of the ARAMIS trial originally published in the New England Journal of Medicine. 

4 ways AWARE for All has adapted in 2021

Written by Ellyn Getz and Phyllis Kaplan
egetz@ciscrp.org
pkaplan@ciscrp.org

In 2020, the AWARE for All program experienced an abrupt and drastic transfer from a live-educational event model to a completely virtual engagement program. The CISCRP team shifted quickly to create accessible and meaningful virtual programs to educate the public about clinical research participation and address concerns about the COVID-19 vaccine. 

AWARE for All gathered great visibility as a fully virtual engagement program. Over 60% of our health fair visitors and webinar attendees represented public and patient communities. Walso hosted over 30 exhibitors per virtual health fair. In addition, each of the five campaigns that participated shared educational content with over 700,000 people through creative marketing and communication strategies. 

CISCRP was proud to work with the AWARE Industry Consortium, a team of ten leading pharmaceutical companies and clinical research service providers. The team also includes local advocacy and research groups to assist in leading this national outreach campaign. We are so excited to build on this momentum in 2021. 

Year 2 of the AWARE Industry Consortium will continue to focus energy and resources on community-based education. Our main focus will be to increase clinical research literacy and engage with diverse communities around the world. Consortium members include Biogen, CSL Behring, EMD Serono, Genentech, IQVIA, Janssen, Novartis, Otsuka, Pfizer, and WCG. And this year, we plan to finetune our approach to expand our reach and leverage the benefits of virtual education. 

Here are the most notable adaptions in 2021 with hopes to host in-person programs again in 2022: 

  1. Information exhibit center…in virtual reality. The team partnered with Illumina Interactive to build a virtual health fair, mimicking as close as possible the experience of an in-person exhibit hall. This virtual experience was recognized by Platinum eHealthcare Leadership award and the OMNI Awards in the Health and Fitness and Non-Profit categories. Our plan is to include one national health fair with add-on regions, share participant stories, and have health and wellness pavilion. 
  1. city-specific approach to a regional focusTaking advantage of the virtual environment, the events will be spread out over five regions across the United States, something we have never done beforeThis expanded focus should reach over 10 million people! 
  1. 2 to 3 therapeutic areas will be featured at each event. We will feature 2 to 3 therapeutic areas or medical conditions per event This will help increase engagement with those who have a special interest in these areas. 
  1. Our 2-hour webinar will be shortened to 90 minutesVirtual fatigue is something that has to now be considered, and it is no joke! We have decided to shorten the event to 90 minutes to avoid this. 

We invite you to join us as we take AWARE for All virtually on the road to these regions: 

  • AWARE  Northeast: April 15th 
  • AWARE  Northwest May 20th 
  • AWARE  Midwest July 22nd 
  • AWARE  Southwest: October 21st
  • AWARE  Southeast November 18th  

Registration details are posted on the CISCRP events website. 

If you are interested in participating as a speaker, virtual exhibitor, or outreach supporter, please email Phyllis Kaplan at pkaplan@ciscrp.org. 

Doing our part: Improving Diversity in Clinical Research Participation

Written by Behtash Bahador | bbahador@ciscrp.org

You may have heard that the people who take part in clinical trials are not as diverse as the people who might use the treatments or vaccines being studied in trialsWe see a lack of diversity in age, sex, gender, race, and ethnicity when it comes to clinical trials. When certain groups are not well-represented in trials, it could mean researchers cannot learn enough about how well treatments or vaccines will work for them. 

Among the groups who have not been well-represented in clinical trials for many years are African Americans and Black people, Hispanic Latinos and Spanish people, and other people of color. The events of 2020 have raised the public’s awareness of social inequality and health gaps among these populations. There is also increased interest among the public about the role of clinical research in developing treatments or vaccines. 

At CISCRP, our mission has always included giving all patients and members of the public access to clear and unbiased educational information about clinical research and the results of trials. We also help researchers ensure there are fair opportunities to participate in clinical trials. As the clinical research community increases their efforts to remove the barriers that prevent equal representation in clinical trials, our staff continues to respond with a deep sense of urgency and commitment to do our part. 

 

“Nothing about uwithout us”the role of community engagement and education 

Like most public health challenges, making sure there is equal representation in trials requires changing several parts of a complex systemCISCRP supports making this change in 2 important ways:  

1) Engaging and working together with the communities who are not well-represented to understand the barriers they face, and 

2) Applying what we learn to help remove those barriersincluding developing educational materials with the input of those communities to make sure we are effectively connecting with them and empowering them. 

Some work has already been done to identify the barriers that prevent these communities from participating in clinical trials. The graphic below shows some these barriers. It was created based on what CISCRP has learned through working directly with members of the communities who are not well-represented in trials. 

But, the barriers each community faces are not the same. While some of these barriers can be removed with broad brush strokes that help everyone, there is no one-size-fits-all solution. This is why it is important to work closely with each community and make sure their perspectives and feedback are applied when creating and completing projects or programs aimed at removing these barriers.   

What CISCRP is doing 

To carry out our mission, CISCRP is continuing to take on projects that support improving diversity and inclusivity in clinical research. 

Our Health Communication Services team is focusing on developing educational materials that engage and inform the communities that have not been well represented in clinical trials. By seeking feedback from the community while we create these materials, we strive to make sure everything we develop is easy-to-understand, unbiased, and culturally appropriate.   

Our Research Services team continues their work to make sure we gain perspectives and insights from underserved communities through focus-groups, interviews, surveys, and user-testingOur projects center on working directly with individuals who represent the diversity that we hope to achieve in clinical trials. This includes different age groups, different sexes and genders, and diverse races and ethnicities. 

Finally, our Community Engagement and Media Awareness teams have the important role of reaching the communities who have not been well represented in clinical trials and connecting them to educational resources. We also connect them to researchers and patients who have taken part in clinical trials beforeThrough our WebinarsMedia Campaigns, and exciting Events, we are making sure the right people are having conversationabout the lack of diversity in clinical research.  

2021 Perceptions and Insights Study to focus on diversity, inclusion, and the impact of the COVID-19 pandemic

Written by Shalome Sine | ssine@ciscrp.org

Planning for the 2021 Perceptions and Insights Study is underway! 

It is more important than ever to better understand the public’s views of and experiences with clinical trials. The COVID-19 pandemic and vaccine development have taken over headlines globallyturning the public’s attention to the topic of clinical research and the pharmaceutical industryThis past year also saw the United States address racial inequities that have been built into our systems. The public’s focus on clinical trials alongside diversity and inclusion issues is unique. 

So, how have these events affected the ways that patients and the public feel about the importance of diversity and inclusion, specifically in terms of clinical trial participation? 

These are some of the biggest questions facing the industry, and CISCRP’s Perceptions and Insights Study can help to answer them. The Perceptions and Insights Study is a global survey of thousands of respondents that has taken place every 2 years since 2013. The study assesses current attitudes toward clinical research and experiences participating in clinical trialsAs we prepare and plan for this year’s survey, here are 3 ways the 2021 findings can help inform your patient engagement strategy: 

  1. Trends: We’ll carry questions from previous years so that we can continue to track trends over time. This will allow you to see how the events of 2020 have impacted perceptions and experiences of clinical research compared to previous years.

  2. COVID and the rise of remote clinical trial models: We’ll ask those who participated in clinical trials whether they used technologies or alternative clinical trial models (like virtual or home nurse visits), as these were often used in 2020 to limit in-person contact and reduce the spread of COVID-19We’ll also ask how these new technologies impacted their experiences and satisfaction as a clinical trial participant.

     

  3. Diversity and inclusion in clinical trials: The 2021 survey will also include new questions on diversity and inclusion in clinical trials, offering valuable insights into the views of patients and the public on the importance of including a diverse group of participants in the clinical research process. We will also look at the motivations and experiences of underrepresented communities to identify ways to improve engagement among these groups. 

The survey will launch later this spring, with results available in September 2021. Keep an eye on the CISCRP website to be notified as soon as results are available! 

Click here to review the results of the 2019 Perceptions and Insights study and see general trends found over time so far. 

CISCRP supports Operation Warp Speed vaccine sponsors with Plain Language Communication

Written by Jill McNair | jmcnair@ciscrp.org

In December 2020, CISCRP announced that it is providing plain language communication consulting and services to companies involved in Operation Warp Speed.” As readers may know, Operation Warp Speed is a public-private partnership started by the US government to help in the development, manufacturing, and distribution of COVID-19 vaccinesCISCRP has pledged to volunteer our knowledge and resources to assist Operation Warp Speed sponsors. We are pleased to be providing our services to AstraZeneca, Janssen Pharmaceuticals, Moderna, and Pfizer. 

 

For more than 10 years, CISCRP has been translating scientific clinical trial results information into plain language for patients and the public around the world. To deliver on our pledge, CISCRP is continuing to do this by assisting Operation Warp Speed vaccine sponsors in a variety of ways. This includes: 

  • developing, producing, and distributing plainlanguage trial results summaries 
  • translating scientific medical journal articles into plain language 
  • preparing plain language content to be communicated in print and digital formats  

 

Oxford PharmaGenesis, a global provider of medical, regulatory, and scientific writing, will also be volunteering its services together with CISCRP to support Operation Warp Speed sponsors. 

The demand from the public, patients, and the healthcare community for plain language information about the results of COVID-19 vaccine trials is high. Health officials and Operation Warp Speed sponsors also believe that providing clear information and results is necessary to gaining public trust and support for other vaccination programs in the future. 

Said Ken Getz, CISCRP’s founder and board chair“Given the incredible time and resource pressures that Operation Warp Speed vaccine sponsors are facing, CISCRP decided to donate staff time and expertise, its editorial panel of patients, and print production and distribution costs. We’re very pleased to be collaborating with so many COVID-19 vaccine sponsors. And in the process, CISCRP can ensure consistenthigh quality, and compliant practices across sponsor companies. 

 

Supporter Spotlight: Educational Video Series

Written by Ellyn Getz  
egetz@ciscrp.org

The general public and patient communities have been receiving a lot of information about how government agencies, private companies, and others are responding to COVID-19. However, there has been limited reliable information about why clinical trials are critical in developing new and promising treatments, and why participation in clinical trials is so important. And, most of the general public do not understand why these new treatments may take such a long time to bring to market, even as industry and other agencies try to speed up this process. Meanwhile, advocacy groups and sites are working hard to address general questions and concerns from patients and caregivers about the clinical research process. 

To help fill these knowledge gaps, CISCRP  in collaboration with 5 leading pharmaceutical companies  has developed short, objective, and engaging videos that cover the following themes:  

  • how new therapies are developed 
  • how clinical trials are changing to meet the current environment 
  • safeguards in place to protect study participants 
  • principles of participation that never change 

We are grateful to the passionate team of sponsors who have collaborated with us on developing and promoting this new series: Eli Lilly, Janssen, Takeda, Biogen, BMS, and Merck. These videos are widely available across digital and social media, and CISCRP has shared these videos with patient advocacy groups, sponsors, and sites around the country. The videos have also been translated into Spanish and Mandarin. We thank the many subject matter experts who recorded segments: Dr. Christina Brennan (Northwell Health)Sharie Douglas (iResearch Atlanta), Taylor Fipps Bayless (PMG Research/AccellaCare), Dr. Jonathan Jackson (Massachusetts General Hospital)Monica Mahatre  (iResearch Atlanta), Dr. Purvi Parikh (Allergy and Asthma Associates of Murray Hill), Dr. Belinda Tan (People Science)and Katherine Trejo (Emerson Clinical Research Institute). 

Since kicking off these animated videos in 2020, CISCRP has developed new clips aimed to assist patients and the public in understanding themes related to clinical research participation. We are currently developing more in Q2 of 2021. Our dedicated and talented Health Communication Services and Research Services teams are passionate about developing credible, neutral content to explain diverse and complex topicsWe have established a streamlined process to quickly turn around animated and live-action videos.

If you are interested in learning about our video capabilities and opportunities to collaborate, drop us a line at 617-725-2750 x320 or via email at egetz@ciscrp.org. 

From the Editor

Dear Readers, 

As we share with you our first newsletter of 2021, we must acknowledge the harsh challenges that defined 2020. The COVID-19 pandemic has changed our way of life. It has disrupted the routines that we took for grantedand for some of us, it has brought deep and lasting loss. It has also highlighted the harsh racial inequalities that continue to existWe find as a society that there is healing needed on many levels. As we welcome the hope that comes from several promising vaccines, we are also reminded of the importance of clinical research. Further, we are reminded of the importance of clinical research education, and of ensuring equal access to information and to treatment across all communities. 

Like so many of our readers, the CISCRP staff has become used to a new way of working, of interacting. With our Boston office closed during the pandemic, we have explored different ways of communicating with each other, and importantly, of furthering our mission. We remain dedicated to helping people better understand clinical research and make informed decisions. As vaccines have taken center-stage in the mediawe have recognized a need for more information about vaccine development and drug development in general.  

We are pleased to share some of the ways in which we have begun to address this need: 

  • Together with several leading pharmaceutical companies, developed a series of animated educational videos and clips about clinical research, including vaccine development 
  • Supported “Operation Warp Speed” sponsors by volunteering our plain language expertise in the development of trial results summaries, medical journal articles, and other media 
  • Launched diversity and inclusion projects across our company to make sure that we engage under-served communities, listen to their voices, and develop our educational materials with their input 
  • Changed our AWARE for All program to a fully virtual model, including targeted educational content to address concerns about COVID-19 vaccines 

We continue to expand our service offerings and educational content to shine a light on the realities of clinical research. Especially during the pandemic, clear communication about clinical trials is critical. In this issue of our newsletter, we share a conversation with Medical Hero Jackie Zimmerman. Jackie knows well the roles of patient, trial participant, and patient advocate. Here, she shares how communicating with others about her MS diagnosis led her to become a patient advocate. 

In celebration of Medical Heroes like Jackie, CISCRP has kicked off this year’s Appreci-a-thon. We invited people to join this virtual fitness challenge starting March 1st of this year. The event runs through March 31st, so it is not too late to sign up!  

Coming up this Springwe will be offering 2 virtual AWARE for All events: a Northeast program on April 15, 2021, and a Northwest program on May 20, 2021.  

It is free to sign up for the Appreci-a-thon and the AWARE for All events. We hope you will join us as we continue to honor Medical Heroes and participate in important discussions about clinical research. Please visit our Events page at http://www.ciscrp.org/ for more information on these and other upcoming events. 

 

Thank you for your continued support as we build upon our existing resources and explore new ways to carry out our mission.  We look forward to connecting with you again in our Summer edition. 

Warm Regards, 

Brandis Pickard

Medical Hero Spotlight: Jackie Zimmerman, MS Advocate

Jackie Zimmerman is an accomplished entrepreneur, marketing professional, former roller derby league president, and non-profit founder with a “can-do” energy that is clear when you speak with her. She is also a patient advocate for people with multiple sclerosis, also called MS. She herself received the diagnosis during college at the age of 21. In the face of this news, Jackie decided to share her story with others. She later became a participant in clinical research. 

“It was a total surprise  no one in my family has it,” Jackie said. “My first question was…am I going to die? I didn’t know anything about MS. And all the patient-facing documentation was targeted at older individuals.” 

Jackie found this surprising, particularly when she learned that most patients are diagnosed in their twenties. To help process this news, she turned to blogging. 

“Initially, I started a newsletter and then it became a blog. This was before social media, so blogs were how you connected. Blogging got me on the scene of patient advocacy. There are lots of advocates now, but then, there weren’t as many,” Jackie explained. 

Jackie was diagnosed with relapsing remitting MSWith this form of MS, symptoms may “flare up” and then seem to be gone for a period of time. Jackie’s first symptoms were during a flare. At that time, the standard of care was given through an injection. 

“Which was really scary at 21  who likes needles?” Jackie said. “My doctor didn’t provide any guidance. He told me to pick whatever medication I wanted. Today, there are many different options and methods of delivery.” 

Another complication in the treatment of MS is that in terms of symptoms, reactions to medications, and outcomes, no two cases are alike. 

Jackie first participated in an MS clinical trial in 2008. However, she was unable to complete it due to unrelated treatment she was receiving forinflammatory bowel disease, also called IBD. Over a decade would pass before Jackie would join another clinical trial. 

During that time, Jackie founded Girls with Guts, a non-profit to support women living with IBDShe became a more active patient advocate. This led to public speaking engagements and work with healthcare and pharmaceutical companies looking to connect with patients. 

There were 2 factors that steered her back to clinical research as a healthcare option for MS. 

“I asked my neurologist questions, because I wanted to keep abreast of things, particularly because I write about them as an advocate,” Jackie said. “Being part of a patient advisory board for a bio-pharma company was also a huge driver. I understand about clinical research participation and what it means. The only factor this second time was a consideration about the time commitment  it’s about a 25-minute drive away. The trial does offer transportation if you need, which I think is awesome, but I don’t need it.” 

When asked about other influences in her decision-making, Jackie commented, “I’m married, so my husband was involved. He said it’s my choice, but I considered him in the process, and all the things you think about when you’re involved in a partnership. I know how to talk with my friends and family about clinical trials to allay their fears. I know how to position it so as not to scare anybody.” 

Jackie did not consult any patient advocacy organizations for guidance before participating. 

“I’m in the minority here because I know a lot more about clinical trials than the average patient. I knew what questions to ask because I had been on a patient panel and participated in an FDA patient advocacy training. I’ve spent a lot of time learning about trials.” 

Jackie shared some wisdom based on her experience with clinical trial participation. 

“Oh man, there’s so much advice,” Jackie replied, laughing. “I have so many angles. Mostly, don’t be afraid of them. It’s not a last resort for MS in terms of treatment. It’s a way to assist your community and get access to medications, years in advance. You’re so heavily monitored that the potential for anything going wrong is quite low.” 

Jackie would consider participating in future clinical trials. 

“Yes  as long as it fits into my life and it’s not an inconvenience or as long as the potential benefits outweigh the potential inconvenience. I know I have a lot of privilege  I can work from home and make my own schedule. If you’re looking at trials that may not fit into your life, know that there are pharma companies working around participant schedules with office and home visits. If it’s not feasible right now, it doesn’t mean that it will never be feasible.” 

 

Note: COVID-19 has led many sponsors to offer virtual clinical trials and the use of digital devices to monitor patient progress. CISCRP recently conducted a survey on the impact of COVID-19 on clinical research. Access the reporthere.

Transforming Clinical Trials: Establishing the Rare Disease Advisory Committee

Authored:  Scott Schliebner, SVP, Centers for Rare Diseases & Digital Therapeutics,
PRA Health Sciences

According to Global Genes, the 7,000 distinct types of rare and genetic diseases impact more people than cancer and aids combined.  PRA Health Sciences understands that rare disease clinical development programs are unique, and to be successful, should be approached from an equally innovative perspective.  PRA Health Sciences’ Center for Rare Diseases believes that by working directly with patient advocates offers us the opportunity to better understand the needs of the rare disease community and how we can transform clinical trials to be more effective and accessible for patients.  We are passionate about the role that patients can play to help better design, enhance, and optimize rare disease clinical trials.

The Center for Rare Diseases believes that by partnering with patients, clinical trials are designed and executed more efficiently and with a focus on the items that are most important to patients.  To help achieve this, we formed the Rare Disease Advisory Committee (RDAC), an independent, autonomous group of rare disease patient advocates who are committed to advising and working with PRA to improve the way patients are integrated into the clinical development lifecycle.  The RDAC will examine and explore ways to optimize the drug development process by involving patients, thereby accelerating clinical development and bringing new therapies to patients faster.  Central to this effort will be a focus on how patients and patient advocacy organizations can be impactful partners throughout the entire drug development lifecycle.

The Committee’s initial two focus areas are on (1) developing a Rare Disease Drug Development Patient Engagement Roadmap, and (2) developing a Rare Disease Clinical Trial Engagement Burden Assessment.  We will also be focusing on how patients, and patient advocacy organizations can be made partners throughout this entire process.  We are excited about the efforts of the RDAC and are committed to bringing new therapies to patients faster.

To learn more about the Rare Disease Advisory Committee (RDAC), please visit https://prahs.com/raretogether 

Members have an opportunity to share educational information and new initiatives being introduced about clinical research to patients, caregivers, advocacy organizations and industry. To submit a brief article for consideration, please contact Joan Chambers, jchambers@ciscrp.org

Making It Clear: Lay Language Summaries

When a patient has invested their time and energy into participating in a clinical trial, it’s of vital importance to provide information about the results in an easy-to-read format. CISCRP’s Health Communication Services (HCS) group specializes in the “translation” of clinical research documents into plain language to help patients understand complex clinical trial information. Among the most common of these is the trial results summary. With the impending implementation of EU CTR (536/2014) and as sponsors increasingly recognize the importance of patient engagement, many companies are beginning to prioritize the development of these summaries, sometimes referred to as “lay language summaries.” These documents play a critical role in the effort to keep patients and the public informed about clinical research and to demystify the process.

Producing a plain language trial results summary is a multi-step process. At CISCRP, the first step is the development of a robust summary template that can be customized from study to study. The CISCRP template is structured to meet EU CTR requirements and incorporate plain language best practices. Yet, it is flexible enough that it can be structured to align with a sponsor’s company requirements and preferences. To keep templates up to date and incorporate lessons learned, CISCRP updates our own template and our clients’ customized templates annually.

When creating content, a patient-centric focus is key. Summaries are most effective when written at a 6th to 8th grade reading level, and it is vital that the content be unbiased, clearly written, and easy-to-understand. During the development process, CISCRP engages volunteer Editorial Panel members to review and comment on a draft of the summary to ensure readability. These panels consist of members of the public (whether or not they are patients), health professionals, and patient advocates. Their feedback is crucial to ensuring that the summary is understandable and strikes the proper tone.

Sponsors working with CISCRP have their option of two different service models: full-service, or Editorial Review only. In the latter model, the sponsor writes the summary and engages CISCRP to perform an editorial review of the draft. This includes feedback regarding plain language best practices and EU CTR requirements. This may also include the implementation of requested graphic design elements.

Some sponsors prefer to pilot their initial summaries using the Editorial Review only approach. This allows them to utilize CISCRP’s plain language expertise and volunteers, while still “owning” the writing and stylistic elements of the summary.

The full-service model, however, engages our plain-language trained staff to assume a more active project management role. This gives valuable time back to an organization’s internal medical writers and creates efficiencies by allowing the writer and editor to communicate more directly. In the full-service model, CISCRP is responsible for the authoring, plain-language editing, content and editorial QC, and graphic design of the summaries. The sponsor has two opportunities to review and comment on the document to ensure it is scientifically accurate. This approach allows each party to focus on their respective areas of expertise, collaborating to produce a document that is plain language friendly and informative.

Producing patient-facing collateral that is transparent and direct is an essential part of the conduct of clinical research. Learn more about CISCRP’s patient engagement and education materials.