CISCRP Releases New Video on Initiative to Spread Clinical Trial Awareness Among Diverse Communities

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

CISCRP’s Inaugural Lay Summaries User Group Meeting

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 

CISCRP Educates LA Community with AWARE Program & Traveling Mobile Unit

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 19th 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

New Educational Brochure Developed for Health Care Providers

CISCRP is dedicated to providing tools to educate study volunteers, their caretakers and clinical professionals. These resources include a portfolio of books, videos, and brochures. Recently CISCRP’s founder Ken Getz identified a need for a resource aimed at Health Care Providers which resulted in a new educational brochure titled “Building Bridges between Health Care Providers (HCPs) and Clinical Research.” This brochure was developed as a guide to facilitate relationships between HCPs and Patients, as well as Clinical Research Professionals and HCPs.

CISCRP’s 2017 Perceptions and Insights Study results showed that of those that have participated in a clinical research study, only 19% reported learning about trials from their primary care physician or specialist. However close to 90% believe it is valuable for their regular doctor to present clinical research study options during their visit.  CISCRP’s latest brochure provides guidance for Health Care Providers who would like to refer their patients to clinical trials. It also includes helpful tips for Clinical Research Professionals to improve their relationships with HCPs.

CISCRP will be working with Transcelerate as part of their Health Care Provider Initiative to help promote the launch of this educational brochure. To view a sample of this brochure click here, and to view more of CISCRP’s educational materials visit CISCRP’s Education Center and Online Store. CISCRP is always open to expanding their library of materials and encourages more companies to reach out to develop new educational materials. If your company is interested in sponsoring the development of new content, please contact Leslie Perez at lperez@ciscrp.org.

Written by Leslie Perez, Marketing & Communications Coordinator

From the Founder

It is with a heavy heart that I write this letter summarizing the features and highlights of this Quarterly newsletter.  For two years, this honor fell to Rachel Minnick, our beloved colleague who passed away in April. 

Rachel was a major contributor to CISCRP’s growth and success during her brief time heading up our marketing and outreach efforts as a senior member of the team.  She always brought clear mindedness; a positive outlook; passion for our mission and compassion for the patient community; a sense of humor; and constant support and encouragement for staff and colleagues.  It was a great privilege for all of us to work and to collaborate with Rachel.

Rachel’s legacy includes our National Media Outreach program, the Ideathon, and our many multi-cultural and multi-lingual educational pamphlets available to patients and their families available online and via health care provider and investigative site waiting rooms and offices.  Having been a study volunteer in clinical trials herself, Rachel was the embodiment of a Medical Hero. In honor of her memory, we’re profiling Rachel in this newsletter’s ‘Spotlight’ feature.

This newsletter also provides a feature on our recent AWARE Los Angeles program and on an interactive and informative redesigned recreational vehicle that, in the weeks leading up to the AWARE event,  traveled to neighborhoods throughout the city to educate the public about clinical research. In addition to CISCRP news briefs and updates, we also highlight two growing service areas: (1) our plain language clinical trial results summary program; and (2) our patient advisory board and patient journey services, and discuss our newest educational brochure designed to assist health care providers in facilitating patient engagement.

Please visit our web site at www.ciscrp.org or call us at 617-725-2750 to learn more about any of our programs and services.  And we welcome your comments and ideas for ways that we can better serve the public, patient communities and all stakeholders in the clinical research enterprise.  Please email me at kengetz@ciscrp.org.

Supporter Spotlight: Janssen

In this edition of the Supporter Spotlight, we are excited to be featuring The Janssen Pharmaceutical Companies of Johnson & Johnson, a major proponent of patient engagement and a national sponsor for CISCRP’s clinical research awareness and patient advocacy initiatives. CISCRP and Janssen recently collaborated on a groundbreaking interactive and experiential mobile unit — the “Journey to Better Health” RV — which traveled around the neighborhoods of Los Angeles during the month of May offering hands-on educational information about clinical research to the public. The “Journey to Better Health” RV also raised awareness of CISCRP’s live AWARE for All community health event held in LA later that month. To hear more about the “Journey to Better Health” RV and AWARE for All program, check out the following article, “CISCRP Educates LA Community with AWARE Program and Traveling Mobile Unit”.

Dr. Andreas Koester, Vice President and Global Head at Janssen Clinical Innovation, commented:

“CISCRP has been spearheading the mission to educate and empower the public about clinical research participation since 2003. It holds an impressive track record in outreach to various communities nationwide through the one of a kind AWARE events. We are proud to have sponsored the AWARE event in LA – one of the most diverse metropolitan areas. A lot of thought went into partnering with CISCRP and Wondros to develop an innovative community outreach tool.”

Andreas also spoke about the “Journey to Better Health” RV, “The mobile unit proved to be a very effective broadcasting channel, yielding nearly half of the AWARE event registrations. It allowed us to interact with hundreds of people from diverse communities across the city. This success is proof, if it needed any, that we can only “go wider and go deeper” if we bring education and information to where the audience is. The mobile unit enabled a leap forward in public engagement and broader reach. As we at Janssen strive to strengthen public clinical research literacy, I look forward to future opportunities for collaboration with CISCRP.”

For more information about Janssen, please visit http://www.janssen.com/.

CISCRP thanks Janssen for its dedication and support in helping to build awareness and to provide education about the importance of clinical research and patient engagement in advancing public health.

We will spotlight a different supporter or volunteer in each Newsletter, so stay tuned for new features each quarter.

Written by Kat Marriott, Marketing & Communications Coordinator

Improving the Clinical Trial Experience: Research Services Shines a Light on the Patient Journey

CISCRP Research Services is on a mission to better understand the evolving needs and preferences of volunteers who participate in clinical research. This has resulted in various innovative collaborations with patients, caregivers and industry stakeholders who are committed to incorporating the patient voice in their drug development processes and improving future participation experiences.

In recent years, CISCRP Research Services has conducted a substantial number of Advisory Boards among both patients and caregivers, which have generated actionable insights on a range of clinical study-related topics such as study design and the informed consent process. Now Research Services is embarking on new initiatives to gain even further insight into the patient experience, with the goal of improving participation and satisfaction with clinical trials. 

These include the Patient Clinical Trial Journey Workshops in which CISCRP facilitators lead patients as they recall their “journey” in a clinical trial, from first learning about their study to their post-participation experience. Through the use of interactive and visual exercises, the Workshops allow patients to map their detailed experiences on a large mural, revealing in-depth patient preferences and areas of opportunity to build the ideal journey.

“Being able to participate in the lupus trial journey workshop made me feel a part of helping the greater conversation around clinical trials,” said one patient who was part of a Workshop. “Talking with the people shaping the messaging for my community made me feel hopeful that together we can make strides in finding new therapies for people like me battling this illness.”

The Workshops provide sponsor organizations valuable information about how to improve the clinical trial experience for patients through a visual final report, which include maps of patients’ actual and ideal clinical trial experiences along a participation timeline.

In other initiatives, CISCRP has worked to bring the voice of the patient to sponsor organizations by presenting findings onsite from the latest CISCRP Perceptions & Insights studies, a global survey conducted every other year to monitor public and patient perceptions of clinical research. CISCRP has also facilitated meetings to leverage these findings and improve patient engagement strategies within organizations. These onsite meetings have led to an increased understanding of the attitudes and experiences of patients and how clinical trials could be designed to better recognize and support their specific needs, while minimizing the burdensome aspects of participation.

“We’ve learned so much from patients and their caregivers over the years and that in turn has helped sponsors transform their clinical trials,” said Annick Anderson, director of Research Services. “We’re excited to offer a variety of easy-to-implement patient engagement tools for sponsors and other organizations to help enhance enrollment, retention and compliance measures while delivering a better patient experience.”

Written by Lewis Rice, Senior Editor of Patient Communications

Remembering Rachel Minnick: A Passionate Clinical Trial Volunteer and Advocate

Rachel Minnick dedicated much of her life as a medical hero.  We honor and remember her legacy.

Rachel, who served as Senior Manager of Marketing and Patient Engagement Alliances at CISCRP, passed away in April of this year at age 39.

Diagnosed with stage 2 breast cancer in 2013, the wife and mother of two fought back fiercely against the disease with a double mastectomy, chemotherapy and radiation. She participated in a clinical trial. And she worked tirelessly to educate others about their treatment options and the clinical research process.

“Rachel had direct experience, which gave her such an inside perspective,” says CISCRP founder, Ken Getz. “It fed her compassion and helped her understand, even more deeply, what so many patients are going through.”

Her husband, Pete Minnick, adds, “Rachel was always pro research, pro clinical trials. She always had that mindset ‘we’re on the cutting edge of medical breakthroughs and technology,’ and she wanted to be on that cutting edge.”

Her cancer was in remission from 2014 to early 2017, until she began experiencing pain in her back and neck. Then her doctors informed her that the cancer was back and had spread to her bones.

“That was a huge blow to us,” Pete says, noting it was stage 4 cancer. “She knew she wasn’t going to be cured.”

In early 2018, the cancer spread to Minnick’s lungs and liver.  She was actively looking for her next clinical trial when she passed away.

Meaningful Work

Getz says Minnick’s legacy lives on through her work: the panels she moderated, the clinical trial awareness initiatives that she spearheaded, her collaborative projects, and the enduring educational brochures, newsletters and other patient communications she wrote during her time with CISCRP.

She was passionate about her job for many reasons. She could focus on the patient community and it also allowed her to work from her Philadelphia-area home, which gave her the opportunity to continue her medical care as well as spend time with the couple’s children, Emily and Sam, now ages 9 and 7.

Being a part of CISCRP was more than a job for her. CISCRP gave her the opportunity to offer hope to other people who were in her same situation.

“She felt like she was helping the entire clinical trial community as well as doing something she liked,” says her husband.

Pete Koerner, a pharmaceutical industry colleague, who worked with Rachel and the CISCRP team for two years, described Minnick as someone who was always enthusiastic, passionate and dedicated to her family, her staff and her work.

“She was invested in clinical research,” says Koerner, explaining Minnick was proud to be the patient voice and wanted to advance the techniques and technologies in the clinical trials process.

She also motivated everyone she encountered at CISCRP and shaped the organization in lasting ways, Getz notes.

Getz reflects on Rachel’s lasting impression, “Her compassion combined with her professionalism and the passion that she brought to CISCRP has inspired so many people – those who reported to her, those who she mentored, and those with whom she collaborated. That will stay with us forever. She truly helped to define our culture and evolve it in such meaningful ways.”

Those interested in making a contribution in Rachel’s memory may send donations to the Breast Cancer Research Foundation.

Supporter Spotlight: WIRB-Copernicus Group

In this edition of the Supporter Spotlight, we are honored to be featuring WIRB-Copernicus Group® (WCG) for their dedication to CISCRP’s mission of raising public awareness and education about clinical research. Last year, WCG not only sponsored our Chicago Medical Heroes 5K Walk & Run to help honor study volunteers that participate in clinical trials, but they also held a reception, in our honor, and surprised us with a generous donation to further support our many patient and public outreach programs.

We asked WCG to share more about their commitment to clinical research outreach and awareness and how these efforts support their overall mission.

CISCRP: In addition to your support of CISCRP’s Medical Heroes Appreciation 5K event in 2017, can you describe WCG’s broader commitment to raising public awareness and public literacy about clinical research?

WCG: “Social responsibility and philanthropy are important elements of the WCG culture. Each year we participate in numerous fundraising activities—both big and small—to improve the delivery of healthcare worldwide. From our non-profit WCG Foundation™, established to raise the global standard of ethical research, to our annual “Party with a Purpose” at DIA, to the many charity walks and drives that we participate in throughout the year, we tend to define “doing well” by “doing good.”

But educating the public about the importance of clinical research is more than a philanthropic endeavor; it is central to the future of clinical development. Each year, we are honored to support CISCRP’s Medical Heroes Appreciation 5K events, which measurably increase public awareness and literacy. In addition, we provide the public with valuable information and thought leadership through CenterWatch and FDANews —two of the leading publishers in the life science industry, and members of the WCG family. These organizations work tirelessly to engage the public in a conversation about clinical research; where it is, where it’s going, and how we can work together to make a difference.”

CISCRP: How do these initiatives fit into your organization’s overall mission?

WCG: “For 50 years, WCG has safeguarded the rights and well-being of research participants. Today, we’re helping to accelerate the pace of ethical research. Our solutions not only protect the rights and welfare of study volunteers, but also help to promote clinical trial efficiency. We’re using our unique knowledgebase and unparalleled data to eliminate waste from clinical research and help the industry to run faster, more efficient clinical trials.”

CISCRP: CISCRP was honored to receive a special award from WCG at the 2017 DIA Annual meeting. Tell us about this award and what led WCG to select CISCRP as the recipient?

WCG: “For 15 years, CISCRP has played a critical role in educating the public about the importance of clinical research participation, and provided powerful resources to benefit every member of the clinical trials ecosystem. It was our privilege to recognize CISCRP for its outstanding contribution to the field of clinical research, which includes reaching ONE MILLION households through its AWARE for All program. By promoting informed participation in clinical research, CISCRP is helping to make progress possible.”


For more information about WCG, please visit www.wcgclinical.com
We want to thank WCG for their dedication to CISCRP’s mission and for helping to create awareness about the importance of clinical research. 

We will spotlight a different supporter or volunteer in each Newsletter, so stay tuned for new features each quarter.

By: Rachel Minnick 

MT Pharmacy: Reactions to CISCRP’s New Educational Public Service Initiative

CISCRP recently launched a digital public service initiative called the “MT Pharmacy” designed to increase awareness of the important role that clinical research participants and clinical trials play in advancing public health. The MT Pharmacy video captures reactions and highlights from a temporary store-front pharmacy that was set up on a busy street in Newark, NJ and featured vacant shelves and barren displays – a completely empty pharmacy. The purpose of the initiative was to show that without clinical trials, pharmacy shelves would not carry the necessary medicines and therapies that are used to treat diseases and illnesses for millions of people around the world. 

The video runs a little over 3 minutes in length and to date has received over 5,000 views across various social media platforms. Overwhelmingly the reactions from industry professionals, patients, and members of the public have been that the MT Pharmacy showcases an important and critical message about the importance of clinical trial participation. Many have commented that it’s an innovative approach to educating the public about clinical research and challenges people to think differently about how medicines are brought to pharmacy shelves. As more and more people view and share the video, there are new opportunities for open dialogue about what it means to participate in a clinical trial. The initiative helps to make the topic of clinical research and clinical trial participation personal and relevant. 

The MT Pharmacy video has also been viewed at several industry events and symposiums and shared among research and industry professionals. The initiative was sponsored by Sanofi USand was developed with the assistance of Langland. Many organizations have expressed interest in working with CISCRP to replicate this initiative within their own cities as a way to further increase public impact.

The MT Pharmacy has already received accolades by taking place as 1st Runner Up in the SCOPE 2018 Participant Engagement Awards. CISCRP plans to submit the MT Pharmacy to several other outreach and awareness awards throughout the year. 

In an effort to encourage clinical trial awareness and education we encourage our CISCRP community to view and share this important video with family and friends across social media using the hashtag #mtpharmacy. The link to the video can be found here: https://youtu.be/w90COWBW03g

By: Rachel Minnick