“Advocate for Your Health” is the underlying theme for CISCRP’s upcoming AWARE for All – Clinical Research Education Day at Johns Hopkins’ Turner Auditorium on April 17. This three-hour program from 5:00pm – 8:00pm will feature free health screenings including HIV and Hep C, mental health, dental and oral, flu vaccines. Attendees will also have the opportunity to interact with research professional and clinical research study volunteer panelists from around the Baltimore area, and a diverse selection of community organizations exhibiting in the Information Alley.

This is a particularly special program to kick off the 2019 event repertoire as CISCRP is dedicating AWARE – Baltimore in honor of former advisory board member, Christine Pierre. Since our founding, Christine has been a passionate supporter of our mission: she served on our advisory board, was involved in our planning team for numerous events, and also personally encouraged industry professionals to support CISCRP’s programs and initiatives. She organized annual study volunteer appreciation events and donated proceeds to the AWARE for All educational initiative. A Medical Hero herself, she contributed tremendously to empowering patients as partners in the clinical research process.

Christine was passionate about and dedicated to communicating the essential role of investigative sites in the clinical research process and in every study volunteer’s experience. Christine and Ken Getz often shared the podium to advocate for this critical relationship. In an interview with PharmaVOICE back in June 2013 that shared the impetus behind launching the Society for Clinical Research Sites (SCRS), Christine stated, “The sites are the closest to the nucleus of this industry – with the center being the volunteers. Without sites there are no subjects, no data, no research, and no advancement of medicine…sites are the only place in the research ecosystem that have the responsibility and privilege of interfacing with volunteers.”

The AWARE for All event and grass-roots outreach campaign focuses on what sites are doing to ensure that patients feel like they’re a part of the team.  It also empowers the public with educational resources and tools to advocate for their health. We miss Christine greatly and are grateful for her tremendous contributions to the clinical research enterprise.

Details:

When: Wednesday, April 17, 2019
Time: 5:00pm – 8:00pm
Where: Turner Auditorium at Johns Hopkins University (720 Rutland Ave, Baltimore, MD 21205)
Cost: Free
Reserve Your Spot Here

Highlights:

• Free health screenings
• Free dinner
• Presentations by researchers, medical professionals, and study volunteers
• Networking opportunities among patient advocacy groups, community organizations, research centers and sites, academia, CROs, and sponsor companies

Written by Ellyn Getz, Senior Manager of Development and Community Engagement

With the advent of spring, I think many of us experience a feeling of hope that we won’t have to endure much more wintery weather.  Similarly at CISCRP, there is a sense of hope, but it is year round.  It’s a feeling that the work we do helps to make the world of clinical research a better place. 

Examples of this vibrant feeling permeate through this issue’s articles. In our Medical Hero Spotlight, we learn about the amazing and heartwarming story of Melinda Bachini—a wife and mother who is battling a rare disease, and who has fought it by volunteering in a clinical trial. 

In other articles, we spotlight how:  

• The American Society of Hematology (ASH) Research Collaborative and CISCRP’s Research Services are working together to engage Sickle Cell Disease communities  
• CISCRP’s Plain Language Services are critical and are helping the National Cancer Institute 

• The late Christine Pierre’s legacy lives on in the organization she founded: the Society for Clinical Research Sites  

Christine was a passionate supporter of CISCRP’s mission and a driving force for greater research site sustainability.  Our upcoming AWARE for All Baltimore event is dedicated in her honor.  In addition, we are excited to announce the 3rd edition of Ken Getz’s book, The Gift of Participation.  This new volume contains important updates, as well as an even greater patient focus.  Finally, let me take a moment to congratulate the winners of our first annual virtual fitness challenge, the Medical Heroes Appreci-a-thon.   

Companies with the Most # of Teams:  
1st Place:  Syneos Health 
2nd Place:  Amicus Therapeutics 

Most Spirited Team:  
Mercy Research 

With so many advancements in modern health care and a greater commitment to patient centricity in clinical research, it’s hard not to have hope.  Please enjoy this issue of Partnering in Clinical Research.  

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

CISCRP Research Services is excited to announce a collaboration with the ASH Research Collaborative (ASH RC).  The ASH RC was established by the American Society of Hematology to foster collaborative partnerships, accelerate progress in hematology, and improve the lives of people affected by blood diseases. The ASH RC is working with CISCRP, the organization’s community engagement partner, to facilitate a series of national interactive workshops designed to engage the local Sickle Cell Disease (SCD) communities and learn about their most important needs as it relates to emerging treatment options.  In addition, the workshops will aim to find the best ways to raise awareness of and increase participation in clinical trials for SCD. 

The learning from the workshops will lead to the development of an SCD Patient-Oriented Research Priority Report to be shared with SCD patient and medical professional communities. Findings from the workshops will also generate a long-term, multi-pronged patient engagement plan to accelerate treatment development for SCD.

CISCRP will plan and execute eight half-day community-based workshops targeting four distinct SCD community populations – parents of children living with SCD, adolescents, young adults transitions from pediatric to adult care, and adults living with SCD. All workshops will be conducted during the first year of the project in the following US cities: Orlando, FL; Atlanta, GA; Washington, DC area; New York, NY; Los Angeles, CA; Oakland, CA; Chicago, IL, and Houston, TX.

The workshops’ primary objectives will be to:

• Better understand experiences of those living with SCD and the communication channels/support systems used by each of the four SCD community population segments and their families; evaluate experiences accessing clinical care and treatments 
• Assess current level of awareness, knowledge, and perception of clinical research; map decision-making process
• Identify the most critical clinical trial considerations for each SCD patient population segment and their families
• Cultivate trust and partnerships with local communities by engaging key community leaders to participate in the workshop

We at CISCRP would like to thank ASH RC for their collaboration and for their relentless work to engage patients along the journey to finding answers for sickle cell disease.

Written by Annick Anderson, Director of Research Services

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

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

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 60^th 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

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