Since 2003, CISCRP has developed educational content about clinical research that is written in plain language for study volunteers and the public. Our Communicating Trial Results program develops Lay Language Summaries, and we also help researchers ensure any document, website, or other communication is understandable and easy to use for the intended audience.  

The process for creating our high-quality deliverables is thoughtful, evidence-based, and rooted in community-engagement. A key component of this process is the Editorial Panel review, which plays a critical role in connecting the voices and experiences of key stakeholders. Read on to find out why these Editorial Panels are so important, what they are, and how you can become involved.

Why do we have Editorial Panels?

During the development process of the plain language materials, CISCRP includes the perspectives and experiences of patients, advocates, and healthcare professionals. It is critical to include the voices of those who have a stake in clinical research, particularly patients and advocates. Our Editorial Panel participants provide insight into how to best communicate clinical trial results and the clinical trial experience in a way that is accessible and relevant.

The goal of our Editorial Panels is to improve all plain language documents before they are finalized and distributed to patients of clinical trials. In fact, every Lay Language Summary that CISCRP develops is reviewed by an Editorial Panel.

What is an Editorial Panel?

Editorial Panels include individuals from three core groups:

• Patients and the general public – we include feedback from those with clinical trial experience, and those who are not as familiar with the process in order to capture a variety of perspectives.
• Patient advocates – local, community, and national advocates from patient advocacy agencies and organizations can help improve how CISCRP communicates the trial results by sharing their insight and emphasizing key information on behalf of their communities.
• Health professionals – this group can include clinical research professionals, physicians, nurses, and others who utilize their clinical experience and knowledge to ensure that the summaries are clearly written and scientifically accurate.

Editorial Panel participants volunteer their time to review a variety of plain language materials and provide their feedback. We welcome people from all over the world to volunteer. If you are interested in participating or would like to learn more about this opportunity, please feel free to contact Rachel Weitzner, our Editorial Panel and Engagement Associate. She may be reached at rweitzner@ciscrp.org or by phone at 617-725-2750 x108. If you are interested in learning more about the services offered by CISCRP’s Communicating Trial Results department, please contact Jay Matthews, our Business Development Executive, at jmatthews@ciscrp.org.

CISCRP is relaunching a special “Volunteer Network” offering members of the community an opportunity to get involved in the nonprofit’s mission to educate the public and patients and engage critical stakeholders as partners in the clinical research process. This network will enrich the study volunteer experience, shift public perception around clinical trial participation, and improve public awareness and engagement. 

CISCRP has always been grateful to have the help of volunteers from all different backgrounds, and as the organization has grown, so too have the programs. Today they are better defined than ever before. To be inclusive of the whole community, which includes professionals, patients, and caregivers, CISCRP’s programs have been revised to include a Medical Hero Alumni Community and an Ambassador Network.

The Medical Hero Alumni Community caters to clinical research participants, and their friends and family, encouraging them to share their personal experience and insight. There are various ways in which Alumni can contribute. Volunteers have the option to join a Patient Advisory Board to review study protocol design, participate on an Editorial Panel to review lay language summaries, or enroll in a Patient Clinical Trial Journey Workshop. CISCRP provides Alumni educational materials and resources to build awareness in their communities. With ongoing support, they can confidently host booths at local health fairs, libraries, educational institutions, and other public venues. Alumni are also welcome to attend and/or speak at CISCRP’s events, including Medical Hero Appreciation 5Ks and AWARE for All. In addition, Alumni are encouraged to submit a personal story to be featured in the “Medical Hero Spotlight” section of CISCRP Quarterly Newsletter.

The second part of CISCRP’s Volunteer Network is the Ambassador Program. Newly tailored to industry professionals, Ambassadors are welcome to share their expertise about clinical studies in settings that focus on improving clinical research processes and advocating for study participants. This program gives professionals an outlet where they can continue to use their talents to make a real difference in public health outside of their everyday work responsibilities. Examples of ways Ambassadors can help are: join a Speaker’s Bureau; present at CISCRP-hosted AWARE for All events; host booths; share CISCRP’s educational materials and resources; and serve on the organization’s event planning teams.

CISCRP also creates opportunities for the general public to get involved. Opportunities include supporting CISCRP’s upcoming events, sharing CISCRP’s PSA videos, or simply making .

If you are interested in learning more about the Volunteer Network, please contact Kat Marriott at kmarriott@ciscrp.org.

Written by Kat Marriott, Marketing & Communications Coordinator

We are very excited to be featuring The Foundation for Peripheral Neuropathy (FPN), a public 501(c)3 charity foundation whose mission is to dramatically improve the lives of people living with Peripheral Neuropathy (PN). FPN has collaborated with CISCRP’s Research Services on several Patient Advisory Board meetings by helping to identify eligible patients to participate and by contributing directly to the discussion. Patient advocacy group involvement is critical to the success of Patient Advisory Boards and other engagement initiatives, given their intimate knowledge of the needs and preferences of the broader patient population.  

The first time many people hear of Peripheral Neuropathy (PN) is when they or a loved one are first diagnosed with the condition. It is a very common condition, with an estimated 30 million Americans affected and many more around the world. However, there are remarkably low levels of public awareness of PN given the number of patients who have it.

The Foundation for Peripheral Neuropathy (FPN) follows its mission by:

• Serving as the premier resource of information for patients, their families and healthcare providers
• Accelerating a cure for Peripheral Neuropathies
• Funding collaborative efforts of leading scientists
• Raising awareness of Peripheral Neuropathy

In just over ten years, FPN has grown from a fledgling organization to become the premium source of PN information and research nationwide. Public support is essential to enable the Foundation for Peripheral Neuropathy to carry out its goals and help the millions of PN patients lead better lives.

To learn more about this debilitating condition, please visit www.foundationforpn.org or contact the foundation staff at info@tffpn.org or 847-883-9942. If you are part of a patient advocacy group and are interested in learning more about collaborating with CISCRP on a Patient Advisory Board, please contact us at annickanderson@ciscrp.org or 617-725-2750 ext. 400.

Written by Nova Getz, Research Associate

Since 2003 CISCRP has held its AWARE for All events in 13 cities across the country and abroad. The success of this free educational event has expanded into the development of special initiatives such as CISCRP’s MT Pharmacy pop up shop and its latest project, the Journey to Better Health RV. Earlier this month CISCRP debuted the release of a new video documenting this new initiative.

The RV, developed in collaboration with Wondros and Janssen, was created to raise awareness and clinical research literacy among diverse communities in Los Angeles. Similarly to CISCRP’s MT Pharmacy, the first-of-its-kind RV was developed to offer an interactive experience for the public to learn about clinical research.

The four-minute video highlights CISCRP’s belief that clinical research education truly begins in the heart of the community. Viewers get a peek into the RV, which was equipped with activities and resources that visitors were able to walk through to get a better understanding of the clinical research process. Various community members are also featured sharing their perspectives and experiences during their visits.

CISCRP hopes to bring its Journey to Better Health RV to more communities across the country. Those interested in sharing suggestions on possible locations are welcome to submit their nominations here.

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Written by Leslie Perez, Marketing & Communications Coordinator

As the effective date of the EU regulation approaches, research sponsors are establishing programs that meet the requirement to provide lay language summaries of their clinical trials’ results.

To address the most pressing challenges of implementing lay summary and patient engagement programs, CISCRP held its Inaugural Lay Summaries User Group Meeting on Wednesday, May 16, 2018, at the EMD-Serono campus in Rockland, MA. This unprecedented workshop-style discussion included representatives from AstraZeneca, Biogen, CSL Behring, EMD Serono, Janssen, Novartis, WIRB-Copernicus Group, and CISCRP’s Communicating Trial Results.

CISCRP’s Communicating Trials Results (CTR) service directly supports the development of lay language summary programs. Our dedicated team of lay language experts, medical and legal writers, and translators work directly with some of the top pharmaceutical companies in the world to provide their clinical trial participants with plain language trial results. Since 2012, our CTR team has shipped over 50,000 summaries to trial sites all over the globe.

The inaugural meeting was an invaluable opportunity for CISCRP to meaningfully engage and collaborate with our most active sponsors. The meeting highlighted the need for increased cross-collaboration with our sponsors to further refine the best practices that are established and shared within CISCRP’s program. The shared passion and enthusiasm among attendees for patient engagement and education was truly inspiring.

Robert Janiak, Head of Clinical Trial Transparency at Merck, kicked off the discussion with opening remarks. He was followed by CISCRP Founder and Board Chair Ken Getz, who spoke to the importance of engaging with CISCRP’s program sponsors to build rapport, communicate ideas, and share each other’s enthusiasm and passion for patient advocacy and education.

The role Institutional Review Boards (IRBs) play in plain language disclosure was at the top of the agenda. Change requests from IRBs raise concerns around data consistency across document versions, while IRB requests to submit lay summaries for any purpose beyond awareness can extend an already limited timeframe for submission to the forthcoming EU portal and database. Although several organizations provide guidance for publishing trial results summaries (SAHCRP in the US; HRA in the UK;  MRCT; and Transcelerate), sponsors struggle with a lack of consistency across different guidelines.

Lindsay McNair, Chief Medical Officer at WIRB-Copernicus Group, was on hand to help understand the IRB perspective and address concerns around submission of the trial results summary. Her insights helped the group identify best practices to navigate the situation, suggesting that proactive communication and education is needed.

As a result of this discussion, CISCRP and WIRB-Copernicus Group will collaborate to develop template language to use when communicating with IRBs. We are hopeful this language will facilitate a unified approach to IRB submission of trial results summaries throughout the industry while also acknowledging existing recommendations.

Other forum topics included Trial Result Summary Content and Formatting, Process Considerations for Implementing Successful Programs, and What’s Next for Patient Engagement? We explored these and many more topics in detail over the course of our discussion.

We are very grateful to our friends at EMD-Serono for hosting and to all of our sponsor representatives who shared their valuable insights and first hand experiences. With a growing number of sponsors engaging with CISCRP’s program, we look forward to seeing many new faces at the next meeting!

Written by Robert Mills, Project Manager for Communicating Trial Results 

On Saturday, May 19, CISCRP welcomed over 250 people to its AWARE for All public education program in Los Angeles, California. Participants included elementary students and parents, study volunteers, prospective clinical trial volunteers, research professionals, and other local community members.

With support from Host Sponsor The Janssen Pharmaceutical Companies of Johnson & Johnson, and from sponsors including Lupus Research Alliance, Science 37, and California Clinical Trials, the program exceeded its fundraising goals and introduced a novel interactive element to engage the broader community in clinical trial awareness and education.

In the weeks leading up to AWARE – LA, CISCRP and Janssen launched a first-of-its kind mobile educational unit called “Journey to Better Health.” The mobile unit – a large customized recreational vehicle — visited ten diverse neighborhoods around metropolitan Los Angeles to raise awareness about clinical research, answer questions about participation, and promote the AWARE program. Locations included North Hollywood, Chinatown, and Grant Park. CISCRP ambassadors connected with over 750 people across this ten-day tour and contributed to half of the AWARE for All program’s pre-registration headcount.  The Journey to Better Health RV was developed in collaboration with Wondros, a local creative and media company, with input from local patient and community organizations.

The mobile unit received a strong positive response. CISCRP is currently gathering metrics characterizing reach and exposure. A few preliminary results:  80% of attendees expressed interest in recommending the mobile unit experience to others and a similar percentage gave the educational content quality a very high rating. The majority of attendees reported little prior knowledge about the clinical research process.

The May 19^th program, held at the University of Southern California, represented the culmination of the ten-day mobile unit tour. Program participants were welcomed with free health screenings, food, and access to resources from 25 local community organizations. This event attracted a highly diverse crowd: the majority of attendees identified as Hispanic/Latino(a)/Spanish (30%), White (26%), Black or African American (21%), and other (20%). 44% of attendees reported knowing very little about clinical research prior to attending the program, and 74% had never participated in a clinical trial. After their half-day at AWARE, 92% reported an interest in participating in a clinical trial if recommended by their doctor.

CISCRP was honored to feature keynote speaker Staci Hargraves, Vice President of R&D Operations, Planning, and Strategy for The Janssen Pharmaceutical Companies of Johnson & Johnson. Hargraves set the stage by empowering audience members to make informed decisions about their health by sharing a personal story about how clinical research positively affected her life and the lives of her family members. Dr. Teresa Sligh provided a meaningful, informative overview presentation about the clinical research process and then turned it over to an inspiring panel discussion. Panelists shared breakthroughs in breast cancer research and dermatology treatments, life-changing clinical trial experiences, and advocacy efforts. To close the AWARE symposium, LA Lakers Legend, A.C. “Iron Man” Green answered questions from the audience and applauded the LA community’s efforts in hosting this educational program.  

To view photos of AWARE for All and the “Journey to Better Health” unit’s month-long journey, visit CISCRP’s photo albums on Facebook. Follow CISCRP on Facebook, Twitter, Linkedin, and/or Instagram for video clips of the mobile unit that will be uploaded soon! CISCRP will continue to refine and implement its MT Pharmacy and Journey to a Better Health approaches to raise awareness and to educate the public and patients. We welcome other novel ideas. To support our AWARE for All Educational Events as a sponsor, please contact awareforall@ciscrp.org. If you are interested in having CISCRP visit your community, contact ellyngetz@ciscrp.org.

Written by Leslie Perez, Marketing & Communications Coordinator