By Rachel Minnick

For several years, CISCRP has been organizing and facilitating Patient Advisory Boards to solicit patient feedback on a wide range of areas including protocol design feasibility; clinical trial medicine kits; new technologies and services supporting the participation process; and patient recruitment and retention communications.

As an independent non-profit organization, CISCRP is uniquely positioned to assist companies in organizing and running their Patient Advisory Boards. CISCRP’s extensive relationships with patient advocacy groups, patient communities, and former study volunteers play a key role in ensuring ideal board composition and in facilitating rich, valuable and substantive discussion.

CISCRP’s research services team is currently organizing and conducting several Patient Advisory Boards in collaboration with TransCelerate Biopharma Inc. to gather patient feedback on several of TransCelerate’s key patient engagement initiatives. Through this collaboration, CISCRP has created three distinct Patient Advisory Boards among international patients to gather feedback and suggestions on improving clinical research awareness & access, eLabels and eConsent. The perceptions gained from these patient panels combined with the results of a global patient survey will inform recommendations for new approaches and best practices.

The members of TransCelerate – all leading pharmaceutical and biotechnology companies — are supporting a variety of initiatives to simplify and accelerate the research and development of innovative therapies (for more information on TransCelerate– click here). CISCRP is honored to be collaborating with TransCelerate on this important initiative.

By Rachel Minnick

As 2016 comes to a close, we are kicking off our annual End of Year fundraising appeal here at CISCRP! We know that this is the time of year when important decisions are being made for how to allocate investment dollars in patient-centric initiatives. Our hope is that a donation to CISCRP will be considered as part of this decision.

These vital, end-of-year donations to CISCRP are invested in programs that help to support our mission and engage the public and patients as partners in the clinical research process. As an organization at the forefront of patient engagement, we achieve this through outreach, awareness building, and education. Donations drive the growth of our AWARE for All free health education days, Medical Hero Appreciation 5k events, free online educational resources, Traveling Medical Hero Museum Exhibit, Should I Participate brochure series, and much more!

This fall CISCRP will be hosting three AWARE for All events in Miami, California, and Boston, respectively. There will be over three hundred attendees at each of these events – including clinical research professionals, patient advocacy groups, as well as the general public. These AWARE for All events are just one example of the programs that CISCRP is able to offer to the public because of the generous donations received by our supporters.

Making a donation to CISCRP is making an investment and commitment to educating the public and patients about the importance of clinical research. We thank all of our supporters for their contributions!

By Rachel Minnick

INC Research and CISRP hosted the two day “Inspiring Hope” Ideathon on September 27th and 28th at the modern, funky District Hall venue in Boston’s seaport district. The Ideathon was an innovative, think tank type of event, which aimed to raise awareness of the importance of clinical research participation.

Over 70 ideas, from across the clinical trial community, were submitted for the Ideathon and 13 finalist teams were selected to present at the event in Boston. Finalists’ ideas ranged from a crowdsourcing platform to raise awareness of clinical trials and recruit patients, to the development of a Google Doodle to honor women and minorities who have participated in clinical trials, to a pop up retail pharmacy with empty shelves, plus much more.

Ultimately, the “C2: The Clinical Study Change Agent Collective” team was chosen as the winner of this year’s Ideathon. The judges felt that the C2 team’s idea to create a corporate social responsibility program was innovative, impactful, and would have longevity.
The C2 team was awarded a $10,000 prize by CISCRP to invest in developing their idea into a practical solution that would raise awareness of clinical trial participation among the general public, health care professionals, and patients.

To recognize the participation and efforts of all of the “Inspiring Hope” Ideathon Finalists and Winner, 145 life-saving vaccines were donated to children in a developing country by the Greater Gift Initiative, a non-profit organization dedicated to advancing global health and clinical trial participation.

This truly inspiring event was made possible by the hard work and dedication of all the participants! A special thanks goes out to our Platinum sponsor DrugDev and our Gold sponsors EMD Serono and WIRB-Copernicus Group for helping us to making this event so successful. We would also like to thank our Silver sponsors E-PatientFinder, Greenphire, Medidata, and QD Solutions as well as our Association partners, ACRP and SCRC, and Media Partners, CenterWatch, PharmaVoice, and Pharmaphorum for supporting this tremendous event. For continued photos, videos, and news/updates on the Ideathon, please visit the website http://www.inspiring-hope-ideathon.com/#ideathon-home.

By Susannah Buzard

On July 1^st, the Research Literacy Connections for Tomorrow’s Cures campaign was launched between CISCRP and BlueCloud by HealthCare Point to provide funding in an effort to raise clinical research literacy for students and their families.

BlueCloud by HealthCarePoint is a free online directory that is open to the public, giving patients, research centers, and investigators access to create free accounts. BlueCloud’s network reaches more than 162 countries and is used by nearly one million healthcare professionals, 45 sponsors, 14 clinical research organizations, dozens of universities, and thousands of healthcare and clinical research stakeholders and site organizations. Each time a connection is made by users through the platform, CISCRP will receive a one dollar donation.

CISCRP is very excited about this new collaboration.  The funds raised will directly support CISCRP’s new Traveling Museum exhibit designed to raise clinical research literacy among students and their families. The museum exhibit is currently in the design phase and will provide interactive learning to teach elementary through high school aged children about the role that clinical trials play in advancing public health and the importance and impact of clinical research participation. When it is completed, the Traveling Museum will visit twelve cities in the United States.

“Clinical trial participants give a profound gift that makes new medicines and medical discoveries possible,” said CISCRP’s Founder and Board Chair, Ken Getz. “But public knowledge about clinical research and public awareness and recognition of the gift of participation are very limited at this time. The new museum exhibit, with the help of Blue Cloud’s donation, provides an unprecedented opportunity to reach and educate elementary through high school aged children and their families.”

If you have questions or would like to learn more about this collaboration, please contact Rachel Minnick (Rminnick@ciscrp.org), Senior Manager, Marketing and Promotion.

By Susannah Buzard

CISCRP is pleased to announce that it is collaborating with the National Symphony Orchestra to produce an exciting inaugural event, A Concert to Raise Clinical Research Awareness to be held at The Kennedy Center Concert Hall in Washington, DC.  CISCRP plans to hold the event in 2017.

This concert will be held as part of the NSO’s Sound Health program. The event will feature headlining musicians and will present stories of hope from clinical research volunteers who have been affected by Alzheimer’s, Parkinson’s, and other neurodegenerative diseases. In the past, Sound Health concerts have included performances from Renee Fleming, Yo-Yo Ma, Idina Menzel, Kristin Chenoweth, Steve Martin, Chris Botti, John Legend, and Sara Bareilles, among others

This one-night only performance will highlight the need to improve clinical research literacy in the US and around the world. Concert attendees will receive a program containing educational information about clinical trial participation.

“We hope that this performance will give patients a new forum to share their stories about clinical research participation and how it has affected their lives, specifically those dealing with diseases such as Alzheimer’s and Parkinson’s,” said Ken Getz, CISCRP’s Founder and Board Chair.   Despite the numerous clinical trials that are conducted each year, many patients are unaware of the opportunities and benefits of participating in a trial, and hearing others recount their own personal experiences can provide hope and inspiration.

CISCRP is proud to offer a variety of sponsorship opportunities for those organizations interested in supporting and attending this special concert.  As a supporter of A Concert to Raise Clinical Research Awareness organizations will receive significant visibility both in the local area and within the health care and clinical research community, further reinforcing the commitment to educate and engage patients and the public in the clinical research enterprise. Supporters will receive VIP hospitality opportunities, including reserved seating at the concert.

For additional information about the event, or to learn about sponsorship opportunities, please contact Rachel Minnick, CISCRP Senior Manager of Marketing and Promotion at 610-304-1506 or rminnick@ciscrp.org.

Deciding to participate in a clinical trial can be a difficult decision. Deciding on behalf of a child is often even more difficult.

Sandra Sojka Lagedrost understands the weight of that responsibility all too well. Sandra’s daughter Joanna was only 10 when she was diagnosed with Friedreich’s Ataxia, a rare degenerative nerve disease.

“You’re always asking yourself, ‘Are we covering all the bases? Have we looked everywhere?’  You are so responsible because it is someone else. You’re very conscious of the fact that this is on behalf of your child,” she says.

Unfortunately for Sandra and her husband, John, the decision to enroll Joanna in a Phase III clinical study at The Children’s Hospital of Philadelphia was easy. “We didn’t have a lot of options,” she says. Friedreich’s Ataxia, which is caused by a genetic mutation, is incurable. There are no treatments.

Joanna was in the fourth grade when she pointed out to her parents that she seemed to stumble and fall more than other children. Her observation prompted Sandra to make an appointment with the pediatrician and, ultimately, with a neurologist who diagnosed Joanna’s condition.

Over the next few years Sandra and John sought to strike a delicate balance. They encouraged their bright, determined and independent daughter to enjoy typical childhood activities. At the same time they also took her to physical therapy, sought to learn everything they could about Joanna’s condition and added her name to a disease registry. By the time they learned about the double-blind placebo controlled trial in Philadelphia, Joanna was 14. Her mobility and coordination were deteriorating and she tired easily.

Participating in the trial wasn’t easy. Sandra and Joanna had to make bimonthly trips from their home in suburban Chicago to Philadelphia over the course of 18 months. But Sandra says the research team was accommodating and compassionate.

“It was a very good experience,” Sandra says. “Although we signed the informed consent forms, they explained everything very clearly and in an age-appropriate way to her.  Every time there was even the slightest change in protocol they talked to us about it, and we would have to sign our consent forms all over again. They were really by the book, and I found that reassuring.”

Positive though the experience may have been, the treatment turned out to be ineffective. Joanna went on to participate in a second trial in Philadelphia – a natural history study to help researchers better understand the disease — but as she moved into adulthood, she began to make her own healthcare decisions.

She wanted to focus on college more than clinical trials while she attended the University of Notre Dame.

“When she turned 18 there was a piece of me that was relieved that she was a legal adult and that I could hand off the decision making and recognize her insights. It wasn’t mom and dad any more saying, ‘You have to do this,’” says Sandra, who stepped into a more advisory role. “In some ways nothing changed, but in some ways a lot did.”

Today Joanna, now 22, lives with her parents. She works as an intern in a law firm and as a freelance editor. As an adult she has participated in heart studies in Indianapolis and New York. While Friedreich’s Ataxia’s most visible manifestation is its effect on mobility, it also results in heart disease, which is often fatal.

She says she’s now aware of the amount of behind-the-scenes work it takes to find, pursue and participate in trials, but her overall appreciation for clinical research hasn’t changed. Like her parents, she knows research holds the key.

“Human beings like attention,” she says. “When you consider the fact that someone is paying enough attention and money to put on a clinical trial to focus on your condition, it’s hard to understand how someone would not want to participate. It’s obviously for a very good long-term cause and you may enjoy positive outcomes too.”

In the past year, we’ve been pleased to see tremendous growth within the Patient Advisory Board Panel service. Sponsors, research centers, and contract research organizations are beginning to adopt CISCRP Patient Advisory Board Panels as they recognize the importance of incorporating the patient voice into the clinical research process.

“This recognition leads to enhancements of various aspects of proposed clinical research studies – including protocol design, informed consent, quality of life questionnaires, and patient recruitment materials. Ultimately, Patient Advisory Boards can lead to improving future study volunteer experiences,” says Annick Anderson, CISCRP Director of Research Services.

CISCRP has facilitated over ten Patient Advisory Boards over the past six months in the United States and abroad. As an independent unbiased third party, CISCRP brings a neutral and objective practice, a strong awareness of the clinical research process, and a plethora of experience working directly with patients and collaborating with patient advocacy organizations. Our goal is to ensure the patient voice is heard.

By providing a forum for patients to bring their thoughts out into the open, CISCRP can work with sponsors to modify different aspects of their clinical trial design to better resonate with the target population.

CISCRP’s Patient Advisory Board process works with sponsors to bring together six to eight patients of a particular therapeutic area and a target population for a focus-group style discussion about a variety of patient-facing materials such as study protocols, informed consent documents, and marketing materials. Panelists are prompted by CISCRP facilitators to “put on their research participant hats” and react to the materials as if they were participating in the specific study and receiving them for the first time from a member of the study staff.

Patient feedback offers unique insight into factors that may not otherwise be detected during the study design process. For example, a recent Panel reviewed a study visit schedule that required participants to visit the study site three times each month for a blood draw. The panel discussed how this might work for patients; would it be convenient with work schedules, or would such a design discourage participation?

The primary goal of these Patient Advisory Board Panels is to identify barriers of participation and think of ways to overcome these obstacles, making clinical research more accessible and comfortable for patients and participants.

For more information about this service, please contact Annick Anderson at annickanderson@ciscrp.org.