Including the Patient’s Voice: CISCRP’s Patient Advisory Board Panels Help Organizations Engage with Patients

As one of our fastest growing service areas, CISCRP’s patient advisory board panels, are used by research sponsors, contract research organizations (CROs), and research centers to solicit feedback and gather valuable insights directly from patients and their support network on a variety of critical clinical study-related areas. These may include assessment of protocol/study design, study synopses, informed consent form design, clinical trial medicine kits, and clinical trial technologies.

CISCRP’s unique position as an independent nonprofit organization allows organizations to gather unbiased, meaningful feedback from patients and their caregivers. CISCRP’s close relationships with various patient advocacy groups, patient communities, and study volunteers also play an important role in composing a diverse panel that best represents the desired target audience. To date CISCRP has conducted more than 30 patient advisory board panels.

CISCRP collaborates closely with organizations to organize these panels. As part of the service, CISCRP will work with an organization to develop a discussion guide and patient-facing materials, select and engage panel members, identify a venue, and moderate the panel meeting. Each panel is designed to allow for open dialogue among participants. The size of each panel typically ranges from 6 to 8 individuals and may include patients from varying disease areas, family members, or patient advocates. Depending on the needs of the organization, these panels can meet once or multiple times. CISCRP encourages in-person meetings to build the strongest rapport with patients and their caregivers.

After the panel meeting, CISCRP prepares a detailed report outlining key patient comments and recommendations to deliver back to the organization. Clinical operations teams then utilize these insights to shape proposed clinical trial designs and strategies within the organization. CISCRP’s Patient Advisory Board Panels are an invaluable approach to engaging study volunteers, enhancing their participation experience, and providing insights for ways to improve study feasibility, recruitment, and retention.

Both patients and sponsor organizations have found the experience to be very enriching. One patient who participated in a CISCRP Advisory Board Panel described his experience, “Our patient advisory board meeting proved to be an invaluable experience. We had a unique opportunity to have a voice in the process of how clinical trials are designed and presented to patients. The facilitators from CISCRP were great. We all felt that our opinions were heard, respected, and appreciated which made this a very empowering experience.” At the same time, sponsors value the opportunity to interact directly with patients and develop a better understanding of the patients’ needs. Lysogene’s Chief Patient Access Officer Samantha Parker explained, “The service provided by CISCRP exceeded expectations. The team is clearly well versed in the complex requirements of drug development and were able to quickly apply their established methodology to a new field. The team mastered the necessary balance of empathy and objectivity whilst running the patient advisory board. I will work with CISCRP again in the future.”

For more information about how to organize a Patient Advisory Board Panel at your organization, please contact Annick Anderson.

By: Leslie Perez

Supporter Spotlight: Praxis Communications

In this edition of the Supporter Spotlight, we are pleased to be featuring one of our long-time supporters, Praxis Communications. Praxis has worked with CISCRP to develop creative advertisements for the media campaigns that make up our National Clinical Trial Outreach and Awareness Initiative. They have done this for several of our campaigns and offer this service to CISCRP pro bono. Praxis’ Senior Vice President of Business Development & Strategic Planning, Robert Loll, also serves on the CISCRP Advisory Board.

We asked Praxis to comment on their company’s commitment to raising public awareness about clinical research and how this fits into their organization’s overall mission. We also asked what other specific initiatives – in addition to supporting CISCRP’s National Outreach Campaign – that their companies are working on at this time to raise awareness about clinical research.

CISCRP: Can you describe Praxis’ commitment to raising public awareness about clinical research and how this fits into your organization’s overall mission?

PRAXIS: “Praxis Communications, LLC is a focused recruitment and retention company dedicated to providing unique enrollment optimization solutions for our sponsors. This requires consistent efforts to raise awareness and literacy surrounding clinical trials.

We regularly leverage patient insights, thoughts, and perspectives; from this experience, we’ve learned many deep misconceptions regarding clinical research and what it entails. Educating the public is an essential initiative needed to move toward patient understanding. That’s why we’ve committed ourselves to raising public awareness for clinical research and organizations, such as CISCRP, who advance this common mission.

With Praxis’ extensive in-house capabilities, we have the platforms and tools necessary to spread the message, educate, and raise awareness; we see it as an extension of our mission to disseminate facts about clinical research – doing our part to create a world that trusts, understands, and embraces medical innovation.”

CISCRP: Are there specific initiatives — in addition to supporting CISCRP’s National Outreach Campaign – that Praxis is working on at this time to raise awareness about clinical research?

PRAXIS: “Praxis proudly supports CISCRP’s National Outreach Campaign with creative, digital and analytical services, contributing our resources to this worthy, living campaign throughout the years.

We thoroughly involve ourselves with patient-centered initiatives outside of CISCRP, as well. We attend, present at, and sponsor patient-focused conferences, promote patient perspectives through video series and on our company blog, and take every opportunity to connect with and understand the patient to perpetuate education beginning on the individual level.

In addition, we integrate awareness-raising efforts into our recruitment campaigns whenever possible – we pitch stories to local newspapers near study sites, engage digital influencers to spread awareness online, and hand out educational materials at community events. Our sponsors see recruitment results, and we continue doing our part to spread awareness, one community at a time.

For more information on Praxis, visit www.gopraxis.com.

We want to thank Praxis 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

CISCRP Brings Flagship Community Health Event to Wilmington, NC

On Wednesday, November 15, CISCRP will host AWARE for All, a FREE health and education event, for the local Wilmington, NC community. Attendees will have access to health screenings, dinner, prizes, and information about clinical research and clinical trial participation, and can learn more or register for this event through www.awareforall.org or by calling 1-877-MED-HERO (1-877-633-4376).

The Center for Information and Study on Clinical Research Participation (CISCRP) is bringing its leading community health forum to The Burney Center at UNC – Wilmington on Wednesday, November 15th. CISCRP hosts AWARE for All events in cities all over the world in an effort to bring educational health information directly to patients and the public within the local community. It is a chance for the public to interact with local researchers, clinical trial patients, health care professionals, and advocacy groups to learn more about clinical research and clinical trial participation. The Wilmington AWARE for All event will be held from 5:00 p.m. – 8:00 p.m. EST and is free and open to all.

Barbara Pennington, Clinical Research Program Coordinator at UNCW College of Health and Human Services, remarks, “Bringing AWARE for All to the Wilmington area is an opportunity for our local community to learn more about clinical research and what it means to participate in a clinical trial. We want people to feel empowered about their health care options and hope that we can connect with individuals to help them become more informed about the clinical research process and the important role that study volunteers play in that process.”

Attendees are encouraged to bring family and friends and all will have full access to free health screenings and flu shots, free dinner, raffles, prizes, and giveaways, as well as take-away information and resources about clinical research. The event will feature an “Informational Alley” where local and national community partners and sponsors will set up exhibit tables to interact and share information with attendees.

CISCRP’s Senior Manager of Development & Community Engagement, Ellyn Getz, comments “CISCRP aims to bring AWARE for All to diverse communities in the hopes of educating people about clinical research so that they can make informed decisions about their own health. We are excited to host this program for the Wilmington area and welcome the entire community to take part.”

The event is produced by CISCRP with support from national sponsors EMD Serono and Lupus Research Alliance, local sponsors Carolina Arthritis Associates and StarNews Media, along with other local and community sponsors.

AWARE for All Wilmington will be held on Wednesday, November 15, 2017 from 5:00 p.m. – 8:00 p.m. EST at The Burney Center at UNC – Wilmington, 601 S. College Road, Wilmington, NC 28403. Registration is free, but advanced registration is encouraged and can be done by visiting www.awareforall.org or by calling toll-free 1-877-MED-HERO (1-877-633-4376). As a bonus, those who register and bring a friend or family member will automatically be entered in a raffle to win a Kindle!

Editor’s Note:
Sponsorship and exhibit opportunities are still available; email kseider@ciscrp.org to learn more.

TCS Launches ‘Connected Clinical Trials’ Platform on its Advanced Drug Development Suite

CCT is part of TCS’ Advanced Drug Development (ADD) suite that offers a wide range of cloud based clinical services, including Clinical Data Management, Metadata Management, Pharmacovigilance, and Data Analytics and Insights. ADD is powered by a cognitive engine called ‘Decision Fabric’ that enables automation of complex business processes. ADD leverages the best of cloud architecture and intuitive user experience design in compliance with “good clinical practice” quality guidelines (GCP) and privacy regulations.

TCS’ Connected Clinical Trials Platform provides a scalable cloud solution that addresses patients’ needs through various clinical trial stages, including enrolment, treatment and follow-up stages.

CCT includes four modules:

  • CCT Tracking: utilizes scanners to track all medication kit transactions at the site to prevent dispensing errors, ensuring that the correct medication kit is given to the right patient at the right time.
  • CCT Communication: provides patient-specific, real-time notifications, dosing instructions, tutorial videos via smart phones, enables continuous adverse event data collection, and facilitates personalized patient support in medication dosing and study procedures.
  • CCT Label: employs patient specific and easily readable all-in-one electronic drug labels in the patient’s preferred language.
  • CCT Adherence: enables registration and verification of individual intake via sensor enabled medication packages (smart packages) to eliminate guesswork for medication intake, ensuring that the right pill is taken at the right time.

Janssen Research & Development, LLC collaborated with Tata Consultancy Services (TCS) to build-out TCS’ Connected Clinical Trials (CCT) platform, as part of the Janssen integrated Smart Trial and Engagement Platform. 

The CCT platform has also been tested and proven in a live set-up at TCS’ state-of-the-art User Experience labs with global patient and site advisory boards. This was conducted in collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

“I believe the CCT platform will help us to accurately track patient adherence to the study protocol, while also helping us to more easily and efficiently manage trial supplies at the site,” said Harpreet Isha Monga, B.Pharm, M.Pharm, PHD, Clinical Research Coordinator and Neuropsychiatric Rater at Neuro-Pain Medical Center Inc.

“TCS’ Connected Clinical Trials will enable life sciences companies to harness digital technologies to engage with patients more effectively during clinical trials and significantly improve adherence to medical dosage during those trials,” said Debashis Ghosh, President – Life Sciences, Healthcare, Government, and Energy Business Group, TCS. “TCS’ strong domain and technology expertise makes it well positioned to offer advanced platform solutions catering to specific needs of the industry and we are excited to have Janssen as our first customer on CCT.”

About TCS Life Sciences:
TCS Life Sciences provides top global Life Sciences organisations full service offerings in IT, Consulting, KPO, Infrastructure, and Engineering Services, as well as digital solutions using Mobility, Big Data, Analytics, and Cloud. TCS’ rich industry experience, domain expertise and global footprint allows for a seamless partnership with its Life Sciences customers to help them advance clinical trial efficiencies, accelerate drug discovery, accentuate manufacturing productivity, and amplify sales and marketing effectiveness. In addition, TCS has a dedicated Life Sciences Innovation Lab, which ensures that its customers have the tools and innovative solutions they need to solve complex business challenges.

About Tata Consultancy Services Ltd (TCS):
Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT, BPS, infrastructure, engineering and assurance services. This is delivered through its unique Global Network Delivery Model™, recognized as the benchmark of excellence in software development. A part of the Tata group, India’s largest industrial conglomerate, TCS has over 389,000 of the world’s best-trained consultants in 46 countries. The company generated consolidated revenues of US $17.6 billion for year ended March 31, 2017 and is listed on the BSE (formerly Bombay Stock Exchange) and the NSE (National Stock Exchange) in India.

CISCRP Returns to Chicago to Host Community Health and Education Event

The Center for Information and Study on Clinical Research Participation (CISCRP) is returning to Chicago for the second time this year to host a community health forum, called AWARE for All, on Thursday, October 26, 2017 from 5:00 p.m. – 8:00 p.m. CDT at the University of Illinois Chicago Forum. AWARE for All educational event, established by CISCRP, provides information and resources about clinical research and clinical trial participation to help the public make informed decisions about their health.

EMD Serono, one of the National Sponsors of the event, comments on the importance of bringing this type of program to local communities, like Chicago, in an effort to build greater public awareness of clinical research. “AWARE for All provides a unique opportunity to not only generate awareness around clinical research participation, but in addition offers a very special occasion to publicly thank and recognize the importance of clinical trials participants for their role in the advancement of medical science,” said Paulo Moreira, Vice President, Global Clinical Operations – External Innovation at EMD Serono.

The three-hour event is free and open to all. Attendees will have a chance to receive health screenings and flu shots, eat dinner, visit exhibitors, hear from experts about clinical research, and listen to patients share their experiences with clinical trials. The event will end with a Medical Heroes Appreciation Ceremony, honoring those who participate in clinical trials within the greater Chicago community. There will be prizes and giveaways as well as take-away information and resources about clinical research.

The Lupus Research Alliance, another National Sponsor for the event, remarks on why participating in AWARE for All events can benefit patients and their families. President and CEO Kenneth M. Farber noted, “Clinical research is essential to develop new therapies for people with difficult-to-treat diseases like lupus but awareness and participation is often low. The AWARE for All program makes it easy to learn about the many different clinical studies being conducted in their area so people can consider joining a trial as a treatment option.”

The event is produced by CISCRP with support from national sponsors EMD Serono and Lupus Research Alliance, and local and outreach sponsors Investigator Support Services, Uptown Research Institute, UltraGenyx, American Diabetes Association, and the ACRP – Chicagoland Chapter.

AWARE for All Chicago will be held on Thursday, October 26, 2017 from 5:00 p.m. – 8:00 p.m. CDT at the University of Illinois Chicago Forum, 725 W Roosevelt Road, Chicago, IL 60608. Registration is free, but advanced registration is encouraged and can be done by visiting http://www.awareforall.org or by calling toll-free 1-877-MED-HERO (1-877-633-4376). As a bonus, register and bring a friend or family member and be entered in a raffle to win a Kindle!

Sponsorship and exhibit opportunities are still available; email cbudd@ciscrp.org to learn more.

Lysogene Holds First Parent Advisory Board in MPS IIIA

Lysogene (FR0013233475 – LYS) (Paris:LYS), a leading, biopharmaceutical company pioneering gene therapy technologies to treat central nervous system diseases, today announced the first meeting of the Parent Advisory Board for parents and caregivers of children with Mucopolysaccharidosis Type IIIA (MPS IIIA), also known as Sanfilippo A, in August, 2017 in Minneapolis (US).

The Parent Advisory Board, dedicated solely to patient-related needs, views, and concerns, was organized by Lysogene in collaboration with the National MPS Society, the Cure Sanfilippo Foundation and the Center for Information and Study on Clinical Research Participation (CISCRP). The objectives were to better understand patient and caregiver experiences with MPS IIIA, assess general perceptions of clinical trials for MPS IIIA, and solicit thoughts or reactions to proposed clinical trial design for the treatment of MPS IIIA.

All Advisory Board members had experience as a parent or caregiver of a patient with MPS IIIA and provided their personal experiences with the disease and the challenges of clinical trial participation. During the meeting, parents confirmed the significant life-changing impact this disease has on families and that symptoms and severity can vary between children. Children with MPS IIIA suffer neurological symptoms, including developmental delay, difficulty sleeping, hyperactivity, and issues with motor functions (e.g., difficulty grasping or head turning one way).

“Lysogene is dedicated to placing the patient at the center of the clinical trial design, and feedback from the Parent Advisory Board will be a tremendous addition to our efforts,” said Samantha Parker, Lysogene’s Chief Patient Access Officer. “The value of the meeting was beyond our expectations, and we thank the families for their candid input. We intend to use the valuable feedback in the design of our pivotal clinical trial in MPS IIIA.”

“We appreciate the opportunity to organize this Parent Advisory Board in conjunction with Lysogene as it gives voice to families impacted by this devastating disease,” said Annick Anderson, Director of Research Services at CISCRP. “Understanding the path families take in getting a diagnosis and the challenges in caring for children with MPS IIIA will ultimately result in better treatments for patients.”

About Lysogene: www.lysogene.com

CISCRP Collaborates with Sanofi to Educate Community on Clinical Trials

CISCRP is delighted to announce the upcoming AWARE for All clinical research education and health fair event that will take place in Newark, NJ. The event will be held on Thursday, September 28, 2017 from 5:00 p.m. – 8:00 p.m. at the Paul Robeson Campus Center at Rutgers University – Newark.

AWARE for All is a free community education program, established by CISCRP, that provides information and resources about the clinical research process and clinical trial participation to help the public make informed decisions about their health. The event serves as a platform for dialogue between local patients, members of the public, and advocacy and research professionals. This particular event will have a theme of “Advancing Medicines, Everyone’s Invited” highlighting the importance of diversity in clinical research with a specific focus on diabetes research.

Sanofi US, the Host Sponsor of this event, has been working closely with CISCRP as part of a larger awareness-building campaign about the importance of diversity in clinical trials. “Sanofi is proud to sponsor the Newark AWARE for All event. This initiative will raise awareness of the importance of clinical trial participation,” said Peter Lalli, Head of Sanofi North America Corporate Social Responsibility. “This will not only aid in gaining access to new therapies, but also help ensure medicines are safe and effective across all patient populations.”

Other organizations collaborating on this program include the American Diabetes Association, Angel Flight East, Antidote, CenterWatch, Health Unlocked, Langland, CISCRP’s National Event Sponsor The Lupus Research Alliance, the National Multiple Sclerosis Society – New Jersey Metro Chapter, Rutgers Health Sciences Campus at Newark, the Scott Research Center, and Sisters Network Essex County.

This community health event is also being recognized by Congressman Donald M. Payne, Jr. of New Jersey’s 10th District. Congressman Payne, Jr. comments, “We welcome the AWARE for All program to New Jersey as a chance for local residents to learn more about clinical research, diversity in clinical trial participation, and the importance of making informed decisions about one’s health care options. It is imperative to the advancement of medicine and science to include underrepresented groups in clinical research. I appreciate CISCRP and Sanofi US for bringing this information to the 10th District of New Jersey.”

Registration for AWARE for All is free and open to all. Attendees will have access to a variety of health screenings, dinner, prizes, and giveaways. There will also be informational exhibits, as well as a patient and professional panel discussion about participation in clinical research. The event will end with a Medical Heroes Appreciation Ceremony, honoring those who participate in clinical trials within the greater Newark community.

Ellyn Getz, Senior Manager of Development and Community Engagement at CISCRP remarks, “We are proud to bring this program to Newark for our premier New Jersey-based event. With Sanofi US’ generous host sponsorship, and support from other local organizations, we are working to increase health and clinical research literacy amongst the public, as well as to shed light on the many health-related resources available within the local community.”

AWARE for All Newark will be held on Thursday, September 28, 2017 from 5:00 p.m. – 8:00 p.m. at the Paul Robeson Campus Center at Rutgers University. Register today through http://www.everyonesinvited.org or by calling 1-877-MED-HERO (1-877-633-4376).

Sponsorship and exhibit opportunities are still available; email cbudd@ciscrp.org to learn more.

2017 June Edition

A Very Special Thanks to Our Sponsors:

Cure Forward
Biogen
Pfizer
QST Consultations
Merck
Transcelerate
Janssen
PerkinElmer
Segal Institute of Clinical Research
ACRP
PMG Research

CISCRP would like to recognize and thank Praxis for donating their pro-bono graphic design expertise to create the thank you to trial volunteers advertisement.

VIEW AND DOWNLOAD

Medical Hero Story: Jameisha Brown & Burkitt’s Lymphoma

Eight-year-old Jameisha Brown may not have known the clinical terms for her cancer or its treatment, but thanks to her innate curiosity and the frequent, simple explanations of her care team, she understood her adversary.

That understanding empowered her, she says. Cancer wasn’t a nameless, faceless monster. It was a disease that clinical research would help her fight.

“Meisha,” as friends and family call her, began her battle with cancer in June 1998 during the summer after second grade. She’d lost her energy and had begun vomiting.  Her mother took her to the pediatrician who felt a mass in her abdomen and immediately ordered tests. Within hours Meisha was diagnosed with Burkitt’s lymphoma, a rare, aggressive form of non-Hodgkin’s disease typically found in children.

Just three days after diagnosis, Meisha underwent emergency surgery at M.D. Anderson Cancer Center at the University of Texas. More surgeries and chemotherapy followed.

The doctors, nurses and residents caring for Meisha explained the situation to her. They described her cancer, demonstrated procedures on a teddy bear and drew pictures on a dry-erase board. “They used Clifford books and my Barney puppet to explain the various types of chemo and what the colors meant,” she says. Although her understanding was child-like, it was comprehensive. “I learned about platelets, transfusions, nutra cells and what type of blood I was getting. I think I understood everything about cancer from a child’s perspective maybe even better than my parents did.”

After three months of standard-of-care treatment, Meisha continued to struggle. Her doctor wanted to start her on a combination chemotherapy regimen that had proven successful in adults, but was not yet approved for use in children. As always, her care team took the time to explain everything to her and her parents.

“I knew it was research because it wasn’t talked about in the same way as the other drugs,” she recalls. “The doctors weren’t saying, ‘we can expect this,’ or ‘this has been proven with that.’ With this treatment they were saying, ‘We hope.’ It gave me a sense that I had a fighting chance because there was the word ‘hope’.”

For roughly seven months, Meisha endured a regimen that included rituximab, cyclophosphamide, hydroxyldaunorubicin, oncovin and prednisone (R-CHOP). Her hair and eyelashes fell out, her joints ached and she was exhausted. At one point she developed a septic infection in her chemo port that sent her to the intensive care unit. She spent several weeks on life support.

Despite the pain, Meisha fought, and in 2000 she was declared cancer free.

Today, Meisha, now 24, is working toward a master’s degree at Texas Woman’s University College of Health Sciences and works as a clinical research coordinator at Texas Children’s Hospital in Houston. She continues to participate in clinical research, but now she does so as part of a long-term study of pediatric cancer patients that is being conducted by St. Jude Children’s Research Hospital. The R-CHOP regimen she helped pioneer has become a primary and effective treatment for Burkitt’s lymphoma and a wide range of other B-cell non-Hodgkin’s lymphomas.

Meisha says she’s living proof of the power of clinical research. She credits her care team’s empathy and commitment to communication with helping her persevere throughout her battle with cancer and advises anyone thinking about participating in clinical research to “understand the risks and make sure your questions are answered.”

She also advises them to think broadly about the benefits of research. “Do not just decide to participate because of the potential that it might effectively treat your illness,” she says, “but because of the countless others that may have to fight the same fight.

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.