CISCRP collaborates with NCI-funded Network and Expands Plain Language Work

CISCRP has been working with sponsors since 2010 to produce plain-language clinical trial summaries. As we continue to optimize our plain-language services, we’ve not only explored new ways to improve the summaries; we’ve also applied the same plain-language principles to other patient-facing documents, helping sponsors apply these concepts more broadly.

CISCRP was most recently selected to work with SWOG Cancer Research Network, one of the National Cancer Institute’s National Clinical Trial Network (NCTN) groups, with funding from The Hope Foundation for Cancer Research. CISCRP will work with SWOG and other NCTN network staff and patient advocates to create a plain language template for clinical trial summaries. The template will be available for use by the NCTN groups to ensure National Cancer Institute funded clinical trials are more accessible to patients and caregivers. This work mirrors the early Trial Results Summaries template work we started in 2010, and we were honored to have our expertise recognized with this grant.

CISCRP has also expanded its Communicating Trial Results work to include translating informed consent forms into plain language. The goal here is to achieve an informed consent process that respects and educates adults, children, and teens that are asked to participate in clinical studies, as well as their caregivers. CISCRP works with sponsors to ensure that ICFs are written in plain language and are designed for optimal engagement and understanding. Applying design elements in the template aims at creating a user-friendly document that the sponsor’s clinical teams can easily utilize.

CISCRP has collaborated with multiple sponsors on such ICF initiatives. Feedback from our internal experts in health communication best practices combined with that of our editorial panelists (patients, patient advocates, members of the public, and health care professionals) helps to ensure the ICF is free of confusing medical terminology and unfamiliar technical terms. In one project, for example, CISCRP converted a broad glossary of terms and terminology to plain language that could be incorporated into the ICF. The sponsor’s clinical teams then tested the plain language versions of the ICF template and glossary with a sample protocol, to ensure that both components were easy to use. CISCRP then tested this sample ICF with an Editorial Panel to ensure the “final” version was understandable.

As with all of our plain-language projects, CISCRP focuses on the following areas when developing an ICF template:

  • Clarity of content, identifying specific elements that require simplification for the intended audience. Attention will be given not only to reading level, but also to health literacy, graph literacy, numeracy, and related considerations.
  • Appropriateness of information density, helping to ensure content neither overwhelms readers (e.g., too many new concepts introduced together), nor appears to be hiding or holding back important information.
  • Overall design, with special attention to whether the structure is clear and inviting and is likely to enhance comprehension and ability to quickly locate the most relevant information.
  • Fair and balanced presentation, considering whether any content presents as too positive or too negative, incomplete in an important way, or inaccurate. Consideration will also be given to whether the content is sufficiently sensitive to the likely needs, experiences and expectations of the intended audience.

Through CISCRP’s work with multiple sponsors, we have learned that it’s important not only to create an ICF template in plain and understandable language, but also to consider the graphic design. Is the document visually appealing? Does it include appropriate use of white space, and icons to aid in understanding? These are key considerations, but further, CISCRP suggests that ideally, all sponsor companies consider not only translating their ICF into plain language, but also developing a glossary of terms. This would help clinical teams to choose appropriate language, rather than plugging medical jargon into an otherwise plain language-friendly template.

To learn more about our services please visit Lay Language Summaries and Plain Language Translations. 

Written by Jill McNair, Senior Director of Patient Engagement

Third Edition of The Gift of Participation to be Released Soon

The groundbreaking book, The Gift of Participation, is now being printed in its 3rd edition. Written by CISCRP founder, Kenneth Getz, the new version will contain important updates and will be even more patient focused than before.

Dedicated to honoring and helping people make informed decisions about volunteering for a clinical trial, The Gift of Participation is the ultimate guidebook for seeing patients and their families through this process. The volume offers crucial information on what to expect, where to find trials, and questions to ask.

The book is also an important tool for research and health professionals who make it available in their waiting rooms and frequently give it to patients and their families who are considering clinical trials. In addition, many companies stock The Gift of Participation in their libraries as a valuable reference resource.

Additions to the book include:

  • A new design and layout to make the book even easier to read and reference
  • A new forward by cancer survivor and Medical Hero, Meisha Brown
  • An entire new chapter on the Patient Engagement Movement and new ways that patients, their families, and health care providers are getting involved as partners in the clinical research process
  • A new section on precision medicine and the use of genetic information and bio-markers in clinical research
  • A new section on changing legislation and guidelines about expanded access and the Right to Try for patients who are not eligible for a clinical trial but wish to inquire about gaining access to a new investigational treatment
  • A new section on new approaches to improving study participation convenience, including the use of home nursing networks, concierge services, hybrid and virtual clinical trials
  • A new section on receiving plain language clinical trial results
  • Updated and new charts and figures on the clinical research landscape

Clinical research and health professionals have routinely handed-out earlier editions of  The Gift of Participation to patients and families who are considering clinical trials. Copies of the book have also been made available in waiting rooms; as reference resources in public, school, and company libraries; and given to colleagues as gifts.

If you are interested in pre-ordering copies, please click on the following link: https://legacy.ciscrp.org/portfolio-item/the-gift-of-participation/

Written by Jim Keen, Associate Director of Marketing, Promotion, and Outreach

Plain Language for Health Workshop

Join Behtash Bahador, CISCRP’s Senior Manager of Quality and Compliance and Tufts Alumni, at the Plain Language for Health workshop at Tufts University School of Medicine. Behtash will be participating in a panel discussion on day one of this Writing and Design Workshop for Health Research and Practice for community engagement.

When: March 28 – 29, 2019
Where: Tufts University School of Medicine (Boston, MA)
Link to Register: http://go.tufts.edu/plainlanguageforhealth

More Information About the Program:

The program features experts in health literacy and plain language, interactive peer-learning, and an evening Networking event sponsored by CommunicateHealth. Participants will learn actionable plain language skills and techniques to improve community engagement, trust and transparency, and overall connection with patients, research participants, and the public. It is also an opportunity for people with diverse perspectives, including research teams and participants, librarians, public health professionals, health communicators, community members and others to talk about how to communicate complex health research and practice concepts in ways people can understand. Learn new skills, gain valuable tools, and make lasting connections. For more information visit http://go.tufts.edu/plainlanguageforhealth or email Phil Oettgen, Project Manager, coettgen@tuftsmedicalcenter.org.

CISCRP and PRA Health Sciences Collaborate to Provide Clinical Trial Results Summaries to Patients and the Public

The Center for Information and Study on Clinical Research Participation (CISCRP) and PRA Health are pleased to announce that they are collaborating to prepare and deliver Trial Results Summaries to study volunteers. A key focus for both parties is to provide a more positive overall experience for both patients and families throughout the clinical trial process. Keeping patients informed and engaged with meaningful information through this unique collaboration will help achieve that goal.

Trial Results Summaries — also called lay language summaries or plain language summaries — communicate the results of clinical trials in a format and layout that is easy to understand and accessible to patients and the public. Research sponsors have an ethical obligation to provide plain language results summaries. These summaries also help to ensure transparency and reinforce trust and engagement between sponsors, researchers, clinical trial participants, patients and the general public.

Studies show that although the vast majority of clinical trial participants want to know what research professionals have learned from their participation, very few actually do. A recent study, for example, found that more than 90% of study volunteers want to know the general findings of their clinical trial yet only 11% report receiving the results. In another study, research volunteers indicated that the return of trial results is one of the top reasons for deciding to participate.

The return of plain language trial results summaries will soon become mandatory for studies conducted in the European Union (EU). The EU Clinical Trials Regulation (EU) No 536/2014 is expected to come into effect in 2020 and will require sponsors to provide trial results “for laypersons” through the European Medicines Agency (EMA) portal and database. As a result, a growing number of EU-based and global pharmaceutical and biotechnology companies are looking for support from their contract service providers and from CISCRP.
PRA’s medical writers will draft the Trial Results Summaries and implement the company’s quality control processes to ensure the accuracy of both the data and the message. Based on its expertise in health communication, patient engagement and industry best practices developed through nearly a decade of collaboration with research sponsors, CISCRP will ensure the summaries are easy to understand; meet the needs of participants, patients and the public; and are objective and neutral. CISCRP coordinates the review of all summaries through Editorial Panels composed of members of the public as well as patients, patient advocates, and healthcare specialists in the therapeutic area of the study. CISCRP manages production and  into patient languages of the report and facilitates dissemination to participants through investigative sites.

This collaborative effort will ensure the unbiased, non-promotional communication of study results in a systematic and scalable way. Most importantly, this will provide an effective and reliable means of ensuring that trial participants stay informed about what was learned as a result of their participation. PRA Vice President, Medical Writing and Clinical Trial Transparency, Karen Devcich said, “We are delighted to collaborate with CISCRP as part of a cultural transformation towards real patient engagement and to demonstrate genuine commitment to improving the lives of patients.”

“We are very pleased to be collaborating with PRA to enhance the experience and engagement of their patients,” added Jill McNair, CISCRP’s Senior Director, Patient Engagement. “This collaboration also helps to further our mission to make the return of plain language trial result summaries a standard practice adopted by the clinical research community.”

ABOUT CISCRP
The Center for Information and Study on Clinical Research Participation (CISCRP) is a non-profit organization dedicated to educating the public and patients and to engaging these critical stakeholders as partners in the clinical research process.

The service listed in this post is one example of the many services CISCRP can offer clinical trial sponsors. We are involved in Patient Advisory Boards, Health Communication Consultation and User-Testing through Editorial Panels, Patient and Public Education and Engagement vents and initiatives, free Search Clinical Trials service, and numerous additional services throughout the clinical trial process to certify patient input is incorporated, and that there is consistent engagement with those who volunteer their time to help improve medical treatments.

ABOUT PRA HEALTH SCIENCES
PRA Health Sciences is a full-service global contract research organization, providing a broad range of product development and data solution services to pharmaceutical and biotechnology companies around the world. PRA’s integrated services include data management, statistical analysis, clinical trial management, medical writing and regulatory and drug development consulting. PRA’s global operations span more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and over
15,800 employees worldwide. Since 2000, PRA has participated in approximately 3,700 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 75 drugs. To learn more about PRA, please visit www.prahs.com.

 

CISCRP at Expanded Access Summit

CISCRP is attending the second annual Expanded Access Summit in Washington D.C. The conference focuses on integrating expanded access into the modern drug development process. Behtash Bahador, our Senior Manager of Quality and Compliance, will be moderating a session on patient agency with the Executive Director of the Let Them Be Little X2 Foundation Jeff Leider and the Founder and President of the Turner Syndrome Global Alliance Kelly Ranallo. CISCRP will also be exhibiting at the forum. Stop by our table to meet Nova Getz, a Research Associate at CISCRP, to learn more about our programs and services.

Haven’t registered but are interested in attending? Register Here and use code: CISCRP300 for a special discount.

CISCRP Launches Virtual Fitness Challenge to Recognize Clinical Trial Volunteers

Appreci-a-thon runs throughout the month of February and accommodates each individual’s personal physical activities.

The Center for Information and Study on Clinical Research Participation (CISCRP), a Boston-based nonprofit organization announces that it has launched a virtual fitness challenge to raise awareness and recognize people who participate in clinical trials. This novel event – dubbed the Medical Hero Appreci-a-thon – encourages patients, professionals and the public to show their support.

A large and growing body of research shows that general public awareness and understanding of the important, courageous and altruistic role of clinical trial participants is low. An estimated 1.8 million people volunteered to participate in clinical trials regulated by the Food and Drug Administration in 2018. Without these volunteers, the development of new medical treatments and the advancement of public health would not occur.

CISCRP invites the public, patients, health and clinical research professionals to “go the distance” and show their support by registering and participating in a fitness challenge that follows a virtual Route 66 race course. Participants can conveniently log any and all forms of physical activity to advance along the virtual route each day. Proceeds from the virtual fitness challenge will support educational programs designed to help patients and their families better navigate the clinical research experience.

Since 2003, CISCRP has been producing educational and awareness-building programs and events nationwide including AWARE-for-ALL and the Medical Heroes 5K run/walk.

“We’ve collaborated with the National Institutes of Health and the private sector to develop a number of awareness building campaigns including ‘Behind Every Medicine’, ‘Medical Heroes in Everyday Places,’ and the ‘MT Pharmacy’ during the past 15 years,” said Ken Getz, CISCRP’s founder. “With the new Medical Hero Appreci-a-thon, CISCRP hopes to attract and raise awareness and active support among a much larger audience.”

The Med Hero Appreci-a-thon challenge officially begins on February 1, 2019 and runs through February 28. CISCRP has produced this event in collaboration with Racery, an organization that designs platforms to power virtual fitness activities. Registration is now open and participants can register at . For additional information, call CISCRP at 877-633-4376 or email medheroevents@ciscrp.org.

Our Virtual Platform Partner: Racery

Bayer and CISCRP Collaborate with Patients and the Public to Redesign the Trial Finder Website

Bayer AG recently partnered with CISCRP and TrialScope to redesign Bayer’s information hub on clinical trials. This online resource allows patients and their families, the public and healthcare providers to navigate through Bayer’s clinical trials and provides comprehensive information for a better understanding of the drug development process. The redesign of the website is part of Bayer’s on-going commitment and work to support patient engagement in clinical research by making it easier for patients to navigate and understand the clinical trials.

The Trial Finder website was redesigned and tested in collaboration with patients and members of the public to make it easier to find and understand information about Bayer’s clinical trials happening around the world, including an overview of the results. The site features videos, frequently asked questions, and other educational content about clinical trials, such as what patients can expect if they participate in the research process.

To ensure that the appropriate perspectives were incorporated throughout the development of the website, CISCRP gathered feedback from patients and members of the public who had previously searched for trials. Their insights, such as how to better display lists in the search tool and the need to provide directly accessible definitions of medical terms, was critically important to ensuring that the website is easy-to-use, and that it provides important information, in a manner that is easy-to-understand.

The website allows people to search and filter Bayer trials based on a number of helpful options. Some examples of these are:

  • the medical condition studied in the trial
  • the locations of trial sites
  • the status of the trial, for example: “recruiting” or “study completed”

Each Bayer trial has a webpage that has been designed to show the information patients find most important, in a way that is easy to read and understand.

CISCRP was delighted to collaborate with Bayer and leverage our many years of expertise to develop patient and public friendly materials for the website relaunch. CISCRP conducted in-depth user-testing, to guarantee that this website included as much patient and public feedback as possible. This project reflects the importance of raising clinical research literacy by jointly transforming current tools and innovating new ones for the benefit of patients and the public.

CISCRP looks forward to continuing our support of Bayer and other organizations that are committed to treating patients as partners in the clinical research process.   

About Bayer

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. The Patient Insights & Engagement team of Bayer is happy to receive feedback from users so that they can continue to enhance the trial finding experience, so if you do have comments, please reach out to PIE@Bayer.com

About CISCRP

The service listed in this post is one example of the many services CISCRP can offer clinical trial sponsors. We are involved in Patient Advisory Boards, Lay Language Summaries, Editorial Panels, and numerous additional services throughout the clinical trial process to certify patient input is incorporated, and that there is consistent engagement with those who volunteer their time to help improve medical treatments. CISCRP welcomes new projects like this Trial Finder website, to continue to advance ways we can inform and educate individuals participating, or considering participating, in clinical trials.

Jeanne Cronin: Addressing a Family History of Alzheimer’s

Alzheimer’s is a disease that affects more than 5 million Americans. Jeanne Cronin has an intimate experience, due to her family history. She recalls stories shared by family members about her grandmother, whose behavior resulted in her being moved from nursing home to nursing home. Thinking back Jeanne explains that, although Alzheimer’s was not part of the public conversation at the time, her behavior could very well have been symptoms of the disease. Many years later Jeanne noticed her own mother having trouble understanding things and conversing with her while out to dinner for her 60th birthday. It was at this time that she encouraged her mother to visit Massachusetts General Hospital (MGH) where she was later diagnosed with a mild case of Alzheimer’s.

Despite these experiences, Jeanne maintained a distance from the topic of Alzheimer’s. The disease, on the other hand, continued to take its toll on her family. In 2008 Jeanne’s sister was diagnosed with a mild cognitive impairment. Ultimately her sister passed away at the age of 76. Having expressed a desire to donate her brain to science, Jeanne’s family was made aware that her sister did indeed have Alzheimer’s, along with Lewy body disease. Upon reflection, she shared how grateful she was to have this diagnosis. “I felt like I was able to look back on her behavior, which I previously judged, in a new way.” It was at this time that Jeanne expressed her willingness to get involved in Alzheimer’s research to Dr. John Growdon, a neurologist at MGH who worked with her sister.

In 2015 Jeanne became involved in an Alzheimer’s study at Brigham and Women’s Hospital in Boston. The study is testing an anti-amyloid treatment to evaluate its effectiveness in preventing memory loss due to Alzheimer’s. In order to be eligible to participate, individuals must have elevated levels of amyloid-beta plaque and not be exhibiting any clinical signs of cognitive impairment or dementia. Confident that she would not display signs of plaque, Jeanne completed all necessary screenings. Unfortunately her tests came back positive. The research staff explained to Jeanne that, although the plaque can lead to Alzheimer’s, it is not definitive. Jeanne shared her complete shock and hesitance to continue in the study. “I didn’t want to be reminded of the disease with each visit.” It was her conversation with another patient, already involved in the study, which helped her decide to continue. Both have a family history of Alzheimer’s and were able to speak candidly about their experiences and participation.

Jeanne is currently still enrolled with one year left of the five-year study. Despite being aware that she may be receiving a placebo, Jeanne shares that in her experience, whether she is receiving the drug or not is the least significant part of her participation. She explains that her monthly visits, not only contribute to research, but also help track any possible decline in her memory. Jeanne notes that her visits also serve as a regular reminder of the disease which helps minimize denial, something she often noticed within her family. She emphasizes, “Our minds are so precious that people don’t want to deal with it.”

For anyone considering participating in a study, Jeanne notes, “You will benefit no matter what the outcome. Ultimately all you need is a willing heart to participate.” In fact, she shares that her experience has also changed her perception of the disease. “I’m not as afraid of Alzheimer’s as I used to be.”

Written by Leslie Perez, Marketing & Communications Coordinator

Looking Ahead: CISCRP Gets Ready to Launch 2019 Perceptions and Insights Study

Every two years, CISCRP invites patients and the public around the world to share their opinions on clinical trials through the global CISCRP Perceptions and Insights (P&I) study, which reveals important trends in the views on and experiences with clinical research. The latest 2017 P&I study collected responses from more than 12,400 individuals—making the study the largest of its kind. CISCRP is now getting ready to launch the 2019 study which will build upon the many valuable insights from prior years.

Since the P&I study’s inception, findings have informed researchers of ways to make participation more accessible and less burdensome for study volunteers. Key differences in clinical research perceptions among various populations are also highlighted and offer insight into how to best approach members of each targeted group. To view more detailed findings, click here to download the 2017 P&I study reports online.

With every P&I study, CISCRP considers new questions to include depending on the current issues plaguing the research enterprise. In 2019, the CISCRP research team plans to gather more granular insights into demographic, disease-specific, and other subgroup differences. The organization will also explore new areas, including a more detailed examination of preferences for patient engagement initiatives and the impact those initiatives have. In addition, the team will gauge the perceived role of patient advocacy groups in helping to navigate clinical research participation. Finally, the study will include an additional focus on the Informed Consent process and eConsent.

In preparation for the 2019 study, CISCRP invites industry stakeholders to join a kickoff meeting in February of 2019, where representatives are invited to share their thoughts on topics and questions of interest to help shape the final survey instrument. If you are interested in becoming involved, please contact Annick Anderson, Director of Research Services, at annickanderson@ciscrp.org or at (617) 725-2750 ext. 400.

Written by Nova Getz, Research Associate

USA Today Supplement on Clinical Trials Features Special Articles about CISCRP

As part of CISCRP’s ever-growing mass media campaign, The National Clinical Trial Outreach and Awareness Initiative, we published our most recent clinical trial-focused USA Today supplement on December 7th. This initiative falls under our renowned Medical Heroes Campaign, a public service movement dedicated to engaging the public in thinking differently about clinical research. The supplement reached over one million Americans through both print and digital platforms, educating them about the importance of clinical trials and promoting greater awareness of clinical research. Key print markets included New York, Chicago, Philadelphia, Phoenix, Houston, and Seattle, with a combined readership of 750,000 print readers in combination with our digital reach of over 1,000,000 readers.

Our most recent supplement contained a variety of informational articles and educational advertisements from organizations in the clinical research industry. Merck, Transcelerate, Eli Lilly, and Pfizer were among the major contributors to the supplement, providing content and valuable insight into recent trends surrounding patient engagement and advocacy.

We had a special opportunity to include a few CISCRP-focused articles highlighting the work of our Research Services Department, as well as announcing the release of the second edition of The Gift of Participation. This helpful book is written by our founder, Ken Getz, and will be published in the coming months. With these articles, we hope to bring visibility to the important services that we offer and make the most up-to-date information about clinical research available to the public.

We also included an advertisement thanking and honoring Medical Heroes who have given the gift of their participation in clinical trials to improve public health for all people.  Supporting this important message were organizations including Bristol-Myers Squibb, Janssen, Otsuka, Segal Trials, Biogen, Parexel, Allergan, UCB, Praxis, and EMD Serono.

Our feature story centered on Rachel Petties and her daughter, Alani, who is diagnosed with a rare genetic disorder called congenital, generalized lipodystrophy. Alani bravely battles this disease, which is characterized by total loss of necessary body fat tissues and abnormal storage of fat in various other areas of the body including major organs. She is currently enrolled in a long-term clinical trial program at the National Institute of Health aimed at finding ways to pre-screen for the disease, while identifying and addressing complications earlier on. The story also provided a glimpse into her mother, Rachel’s, everyday life advocating for her daughter and maintaining an inspiring level of commitment to finding a cure.

We will be publishing our next clinical trials supplement in June of 2019. There will be opportunities for sponsoring companies to contribute advertisements and/or editorial content. Contact Kat Marriott, kmarriott@ciscrp.org, for sponsorship options and for the chance to take part in the development of this next educational supplement.

Written by Katherine Marriott, Marketing & Communications Coordinator