New Consortium Launched In Partnership with CISCRP to Improve National Clinical Research Literacy

Research in the literature shows that minority communities have a high willingness to participate in clinical trials and high self-reported general knowledge about the clinical research process. Yet, according to a recent study conducted by the Center for the Study of Drug Development at the Tufts University School of Medicine, minority patients – most notably those of Black and African descent– are highly underrepresented in clinical trials of new medical interventions. Tufts research also shows that patient referral rates into clinical trials among practicing minority physicians and nurses are very low.

To address the critical need to improve patient diversity in clinical trials, CISCRP – in partnership with ten leading pharmaceutical companies and clinical research service providers – has launched a new consortium that will focus energy and resources on community-based education during the next five years beginning in early 2020. Consortium members include Merck, IQVIA, Biogen, Otsuka, CSL Behring, Janssen, WCG, Boston Scientific, EMD Serono, and Pfizer. Representatives from each member company will participate on a steering committee and will provide staff and resources to support the planning and execution of live educational events in five targeted urban centers annually.

“This centralized approach is vital to bring together the necessary oversight and infrastructure required to engage with communities from around the country,” said Jonathan Jackson, Ph.D., study volunteer and The Center Director of Community Access, Recruitment, and Engagement (CARE) Research Center at the Massachusetts General Hospital, Harvard Medical School.

The Consortium initiative builds on CISCRP’s 18-year experience producing and hosting internationally recognized live educational events – called AWARE-for-ALL programs — throughout the United States and parts of Europe. Each event engages a local planning committee comprised of members of the public, patients, advocacy groups, health care and clinical research professionals, offers educational presentations and discussions, as well as free health screenings and information about local clinical trial activity. The consortium also plans to mobilize a pop-up educational exhibit in targeted urban health centers to generate excitement and awareness in the weeks leading up to each live event.

“We are thrilled to be working with Consortium members on this important and novel initiative,” said Ellyn Getz, Associate Director of Development & Community Engagement at CISCRP. “Support, input and insight from consortium members presents an unprecedented opportunity to have an even greater impact on advancing public and patient clinical research literacy over a 5-year time period with ongoing continuous improvement,” she added.

ABOUT CISCRP:

The Center for Information and Study on Clinical Research Participation (CISCRP) is an internationally recognized 501(c)(3) non-profit organization dedicated to educating, informing and engaging the public

and patients about clinical research. CISCRP is committed to providing services designed to help professionals best engage patients as partners in the clinical research process. Visit www.CISCRP.org .

Contact Information
Joan A. Chambers
Senior Director, Marketing & Outreach
CISCRP

Phone: 617-725-2750 ext. 202

www.CISCRP.org

 

Melinda Bachini: How Clinical Trials Gave Her Hope

In 2009 Melinda was a paramedic, wife, and mother of 6 when she began experiencing discomfort, which she initially attributed to the hectic nature of her job. However after discussing her symptoms during a routine check-up her doctor decided to order an ultrasound. It was at this time that a mass was found on her liver. Then on December 1, 2009 Melinda was diagnosed with Intrahepatic Cholangiocarcinoma.

Cholangiocarcinoma, otherwise known as bile duct cancer, is not only rare but difficult to treat. The main form of treatment for patients is often surgery. Initially Melinda was told the tumor was confined to her liver so, a mere 20 days after her diagnosis, she underwent a procedure to have two-thirds of her liver removed. Just a year later, the cancer spread to her lungs. Melinda was now a stage 4 terminal cancer patient.

It was at this time that she took a more active role to learn about her options. Her doctor suggested a clinical trial. Unfortunately she soon found out that, although the drug would have been provided free of charge during the trial, her health insurance would not cover the costs of the trial’s standard care, such as blood work and scans. In June of 2010 Melinda went forward with a treatment plan that involved chemotherapy. Her first round lasted a period of 6 months. During this time, her cancer spread back to her liver, and she continued treatment for another 6 months. Ultimately, as her symptoms grew worse, she decided to stop chemo. Melinda recalls, “It was a hard decision because I didn’t want my children to think I just gave up. But my quality of life was just so bad.”

At that point Melinda mostly stopped looking for clinical trials. She found that while there were active trials, many involved chemo. However upon speaking with her oncologist she became aware of a clinical trial in Maryland at the National Cancer Institute. The month-long trial was federally funded and involved surgery and adoptive cell therapy. Melinda enrolled in the trial in March of 2012. She relates the remarkable change she experienced upon completion of the trial. “Before the trial I had so many tumors on my lungs that I couldn’t walk without coughing. But after the trial I started feeling so much better.” Remarkably she was the first person in the trial to have a positive response.

Melinda spent the next 18 months with no other treatments. But over time, tumors started growing again. At this time researchers decided to take a different approach using one of her T cells. Months later she reported feeling much more active. Melinda spent the next 3 years without treatment until ultimately having to undergo surgery to remove tumors on her right lung. Although not officially able to declare herself in remission, she credits her survival to clinical research.

Often when people are first diagnosed, Melinda shares, they feel like there is no hope. But she points out the progress that has been made and the ongoing research being conducted. She emphasizes, “There are more options now than there were 9 months ago. We’re not going to get better treatments out there until clinical trials are done.” Today Melinda continues to share her story and provide support for others as an advocacy coordinator at the Cholangiocarcinoma Foundation. Looking back on her career Melinda says, “I loved being a paramedic, and I wondered, ‘Will I ever find anything I love as much again?’ And I did.”

Written by Leslie Perez, Marketing & Communications Coordinator

Honoring Christine Pierre’s Legacy at AWARE – Baltimore

“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

 

 

From the Editor

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 and the ASH Research Collaborative to Engage Sickle Cell Disease Community

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 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://www.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.