Announcing The Gift of Participation, 3rd edition, the Ultimate Guidebook on Clinical Research Participation

The Gift of Participation, 3rd edition, written by Ken Getz, Founder of CISCRP, is now available. The book is a comprehensive, easy-to-read guide for patients and caregivers seeking information about the clinical research process.

The Center for Information and Study on Clinical Research Participation (CISCRP) is pleased to announce the release of the third edition of The Gift of Participation. Written by CISCRP Founder, Ken Getz, the book is a comprehensive, easy-to-read guide for patients, caregivers and families to navigate the clinical research process. The new edition offers a fresh look at why participation in clinical research matters. The book features important updates on core information and new areas including the role of social and digital media in clinical research, the collection of bio-marker data and generic materials, evolving rules on clinical trial results disclosure, and more.

Clinical trials are essential to public health. Behind every medicine and treatment available are clinical trials and volunteers who sacrificed their time. Author Ken Getz notes, “For the majority of people, the idea of clinical trials is a new and unfamiliar one. Most people first learn of them at the same time they are diagnosed with a serious illness for which no medication is available or adequate. This rush to navigate the unfamiliar terrain of clinical trials is often overwhelming and confusing.”

According to CISCRP’s 2017 Perceptions and Insights Study, a majority of the public, close to 70%, has never or rarely considered clinical studies as an option when discussing treatment or medication options with their doctor. This may come as a result of common myths about clinical research. The nonprofit CISCRP strives to debunk these myths and help patients and their caregivers understand the clinical research process and what it means to be a clinical research participant.

For many patients, clinical trials can be life changing due to the access participants gain to cutting-edge research and expert medical care. Clinical trial participant Meisha Brown was involved in clinical trials from the time she was 8 years old for Burkitt lymphoma. In the book’s foreword she shares, “An opportunity to participate in a clinical trial offered me a beam of hope and gave me a fighting chance when the state of affairs was seemingly hopeless.”

To order a copy of The Gift of Participation, visit CISCRP’s online store at https://ciscrp-educational-resource-store.myshopify.com/. All proceeds are donated to CISCRP and supports the educational initiatives to assist those seeking to learn more about volunteering in clinical trials.

About CISCRP:
The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP offers free education and outreach to the general public and patient communities. Visit http://www.CISCRP.org for more information or to support CISCRP’s educational initiatives.

CISCRP Invites Atlanta Community Members to Free Health Event

On Thursday, September 26, CISCRP will host AWARE for All, a free health event, for the Atlanta community. To learn more and reserve your spot for this event visit awareforall.org or call 1-877-MED-HERO (1-877-633-4376).

The Center for Information and Study on Clinical Research Participation (CISCRP) invites the Atlanta community to attend AWARE for All, a free health event on Thursday, September 26, from 5:00 p.m. – 8:00 p.m. EST. CISCRP’s AWARE for All is a program that has been hosted in over 60 communities around the world since 2003. This unique program enables the public to learn about the clinical research process and how it plays into public health.

This will be the first AWARE for All event the nonprofit has held in Georgia. CISCRP’s Associate Director of Development & Community Engagement, Ellyn Getz, notes, “We are excited to bring our internationally-recognized program to the Atlanta community and are thankful for the support we have received from many local organizations. AWARE for All events provide a unique opportunity for the public to interact with professionals in the clinical research field and gather the information they need to make informed decisions about their health.”

CISCRP will be providing free dinner and refreshments. Attendees will have access to several free health screenings including Breast Health, Blood Pressure, Depression, Diabetes, Eating Disorder, Flu Vaccinations, HIV, Memory, Nutrition Counseling, Sickle Cell, Smoking Cessation Counseling, and Vision. Local health advocates and researchers will be in attendance to share their resources and services. There will also be an overview presentation about clinical research and a panel discussion featuring research professionals and study participants.

CISCRP is producing the event in collaboration with Biogen and National Sponsor, Lupus Research Alliance (LRA). The LRA National Director of Advocacy and Programs, Diane Gross, MPH comments, “Lupus Research Alliance is proud to continue our support for an event that aims to improve awareness about clinical research, particularly among minority and underserved communities. This is an important chance for the Atlanta community to come together to address the need for greater education and to recognize those who take part in clinical research studies.”

AWARE for All – Atlanta will be held on Thursday, September 26, 2019 from 5:00 p.m. – 8:00 p.m. EST at the Ivy Community Center, 3850 Stone Road SW Atlanta, GA 30331. Attendance is free, but please reserve your spot today by visiting http://www.awareforall.org or by calling toll free 1-877-MED-HERO (1-877-633-4376).

About CISCRP:
The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides free education and outreach to the general public and patient communities. Visit http://www.CISCRP.org for more information or to support CISCRP’s educational initiatives.

Editor’s Note:
Community and research collaborators include: ACRP, Alpha Kappa Alpha Society, Alzheimer’s Association, ARCH, Arthritis Foundation, Biogen, Black Nurses Rock, BrightFocus, Cancer Support Community Atlanta, Clinical Research Atlanta, Cogniciti, Emory Goizueta Alzheimer’s Disease Research Center, Georgia Ovarian Cancer Alliance, HEAL, iResearch Atlanta, the Ivy Community Foundation, the Lupus Research Alliance, Morehouse School of Medicine, Multiple Sclerosis Center of Atlanta (MSCA), and Walgreens.

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, [email protected].

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.

CISCRP Launches Virtual Fitness Challenge to Recognize Clinical Trial Volunteers

Appreci-a-thon runs throughout the month of February and accommodates each individual’s personal physical activities.

The Center for Information and Study on Clinical Research Participation (CISCRP), a Boston-based nonprofit organization announces that it has launched a virtual fitness challenge to raise awareness and recognize people who participate in clinical trials. This novel event – dubbed the Medical Hero Appreci-a-thon – encourages patients, professionals and the public to show their support.

A large and growing body of research shows that general public awareness and understanding of the important, courageous and altruistic role of clinical trial participants is low. An estimated 1.8 million people volunteered to participate in clinical trials regulated by the Food and Drug Administration in 2018. Without these volunteers, the development of new medical treatments and the advancement of public health would not occur.

CISCRP invites the public, patients, health and clinical research professionals to “go the distance” and show their support by registering and participating in a fitness challenge that follows a virtual Route 66 race course. Participants can conveniently log any and all forms of physical activity to advance along the virtual route each day. Proceeds from the virtual fitness challenge will support educational programs designed to help patients and their families better navigate the clinical research experience.

Since 2003, CISCRP has been producing educational and awareness-building programs and events nationwide including AWARE-for-ALL and the Medical Heroes 5K run/walk.

“We’ve collaborated with the National Institutes of Health and the private sector to develop a number of awareness building campaigns including ‘Behind Every Medicine’, ‘Medical Heroes in Everyday Places,’ and the ‘MT Pharmacy’ during the past 15 years,” said Ken Getz, CISCRP’s founder. “With the new Medical Hero Appreci-a-thon, CISCRP hopes to attract and raise awareness and active support among a much larger audience.”

The Med Hero Appreci-a-thon challenge officially begins on February 1, 2019 and runs through February 28. CISCRP has produced this event in collaboration with Racery, an organization that designs platforms to power virtual fitness activities. Registration is now open and participants can register at http://bit.ly/2sjXute. For additional information, call CISCRP at 877-633-4376 or email [email protected].

Our Virtual Platform Partner: Racery

Bayer and CISCRP Collaborate with Patients and the Public to Redesign the Trial Finder Website

Bayer AG recently partnered with CISCRP and TrialScope to redesign Bayer’s information hub on clinical trials. This online resource allows patients and their families, the public and healthcare providers to navigate through Bayer’s clinical trials and provides comprehensive information for a better understanding of the drug development process. The redesign of the website is part of Bayer’s on-going commitment and work to support patient engagement in clinical research by making it easier for patients to navigate and understand the clinical trials.

The Trial Finder website was redesigned and tested in collaboration with patients and members of the public to make it easier to find and understand information about Bayer’s clinical trials happening around the world, including an overview of the results. The site features videos, frequently asked questions, and other educational content about clinical trials, such as what patients can expect if they participate in the research process.

To ensure that the appropriate perspectives were incorporated throughout the development of the website, CISCRP gathered feedback from patients and members of the public who had previously searched for trials. Their insights, such as how to better display lists in the search tool and the need to provide directly accessible definitions of medical terms, was critically important to ensuring that the website is easy-to-use, and that it provides important information, in a manner that is easy-to-understand.

The website allows people to search and filter Bayer trials based on a number of helpful options. Some examples of these are:

  • the medical condition studied in the trial
  • the locations of trial sites
  • the status of the trial, for example: “recruiting” or “study completed”

Each Bayer trial has a webpage that has been designed to show the information patients find most important, in a way that is easy to read and understand.

CISCRP was delighted to collaborate with Bayer and leverage our many years of expertise to develop patient and public friendly materials for the website relaunch. CISCRP conducted in-depth user-testing, to guarantee that this website included as much patient and public feedback as possible. This project reflects the importance of raising clinical research literacy by jointly transforming current tools and innovating new ones for the benefit of patients and the public.

CISCRP looks forward to continuing our support of Bayer and other organizations that are committed to treating patients as partners in the clinical research process.   

About Bayer

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. The Patient Insights & Engagement team of Bayer is happy to receive feedback from users so that they can continue to enhance the trial finding experience, so if you do have comments, please reach out to [email protected]

About CISCRP

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, Lay Language Summaries, Editorial Panels, 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. CISCRP welcomes new projects like this Trial Finder website, to continue to advance ways we can inform and educate individuals participating, or considering participating, in clinical trials.

CISCRP’s Free Community Health Event Returning to Boston, MA

On Tuesday, October 23, CISCRP will host AWARE for All, a free community health event, for the Boston community. To learn more and reserve your spot for this event visit awareforall.org or call 1-877-MED-HERO (1-877-633-4376).

The Center for Information and Study on Clinical Research Participation (CISCRP) invites the Boston community to attend AWARE for All, a FREE community health event on Tuesday, October 23, from 5:00 p.m. – 8:00 p.m. EDT at The NonProfit Center. CISCRP’s AWARE for All program is hosted in cities all over the world and is a chance to bring educational health information directly to patients and the public. This will be the tenth AWARE for All event the local nonprofit has held in the Boston area since 2003.

According to CISCRP’s 2017 Perceptions and Insights Study approximately 70% of the public has never or rarely considered a clinical trial as a treatment option with their doctor. CISCRP’s Senior Manager of Development & Community Engagement, Ellyn Getz, comments, “We are grateful for the support we have received from local community organizations to help us bring this event back to our Boston hometown. Our AWARE events provide the community with tools to help them advocate for and make informed decisions about their health. We encourage lots of questions and networking onsite.”

This educational event features many highlights including a complementary dinner and a number of free health screenings including blood pressure, glucose, glaucoma, flu vaccinations, mental health/depression, and HIV checks. Attendees will have time to connect with local and national community health advocates and researchers to learn about their resources and services. There also will be an overview presentation about clinical research and a panel discussion featuring research professionals and clinical trial participants.

CISCRP is producing the event with the support of Host Sponsor Biogen; National Sponsors EMD Serono and Lupus Research Alliance; Patron Sponsors Tufts CTSI, BMS, and Harvard School of Public Health; and Outreach supporter CenterWatch. Biogen’s Vice President of Global Clinical Operations, Murray Abramson, comments, “Biogen is committed to educating patients and their loved ones about clinical research opportunities. We are proud to support CISCRP’s AWARE for All event to bring a deeper awareness of clinical trials to their communities.”

AWARE for All Boston will be held on Tuesday, October 23, 2018 from 5:00 p.m. – 8:00 p.m. EDT at The NonProfit Center, 89 South Street Boston, MA 02109. Attendance is free, but please reserve your spot today by visiting http://www.awareforall.org or by calling toll free 1-877-MED-HERO (1-877-633-4376).

Editor’s Note: 
Community and research collaborators include: Alzheimer’s Association, American Liver Foundation, Asian Women for Health, Boston University Alzheimer’s Disease Center, Boston University School of Medicine, Brigham and Women’s Hospital, Bristol-Myers Squibb, Dana Farber Cancer Institute, Epilepsy Foundation of New England, Harvard T.H. Chan School of Public Health, National Association for the Advancement of Colored People (NAACP), Novartis, Samaritans Hope, Tufts CTSI, Walgreens, and many other prominent community and research collaborators.

CISCRP Releases New Video on Initiative to Improve Diversity in Clinical Research

The Center for Information and Study on Clinical Research Participation (CISCRP), a Boston-based nonprofit organization, announces a new video featuring an innovative program to increase awareness and knowledge of clinical research among diverse communities. With support from Janssen Research & Development, Pharmaceutical Companies of Johnson & Johnson, CISCRP customized a recreational vehicle — called “Journey to Better Health” — that visited 10 different Los Angeles community events, with over a quarter of a million people in attendance.

Research shows low participation rates in most clinical trials among minority communities yet their willingness to participate is relatively high. CISCRP’s 2017 Perception & Insights study, for example, found that 74% of Hispanics and 80% of African Americans said they would if asked.

The “Journey to Better Health” RV in Los Angeles joins a growing collection of novel, community-based educational initiatives developed and implemented by CISCRP. In 2017 CISCRP launched an empty pharmacy in Newark, New Jersey to highlight the importance of clinical research participation to advancing public health. Both initiatives helped to drive attendance at CISCRP’s live AWARE for All event, a free program that aims to educate and empower the public in making informed decisions about clinical research participation. Featured speaker, A.C. Green (former NBA player and founder of the A.C. Green Youth Foundation), commented, “Everyone’s different. That’s the great thing about us as human beings. [Clinical] studies need to reflect the same thing.”

“Diversity in clinical research participation is essential to the development of targeted and effective new medical treatments,” said Ellyn Getz, Senior Manager for Development and Community Engagement at CISCRP.

With the launch of the new video, CISCRP encourages people to look for the “Journey to Better Health” RV in their community and to learn more about clinical research. The video can be viewed here and will be shared widely with industry professionals and the public.

CISCRP’s 5K Run & Walk Event Honoring Study Volunteers Coming to Boston, MA

The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization, is excited to announce its upcoming Medical Heroes Appreciation 5K Run & Walk in Boston. The 5K will be held in conjunction with the DIA 2018 Global Annual Meeting to celebrate the millions of people who take part in clinical research each year and make new medical treatments possible. All proceeds from the 5K will support clinical research education and outreach programs for patients and their families.

CISCRP welcomes all Boston-based running and walking enthusiasts, patients, caregivers, clinical research professionals, as well as CISCRP supporters and DIA 2018 Global Annual Meeting attendees to participate in this event. Participants can enjoy a scenic loop around Castle Island and a complimentary light breakfast provided by Starbucks and Trader Joe’s. Prizes will be awarded to top finishers, top fundraisers, and most spirited teams. CISCRP encourages all to stay for the bib raffle, which will include fun prizes like an iPad and gift cards.

“Medical Heroes are the millions of people who help advance public health and medical knowledge by taking part in clinical trials each year. We understand the importance of clinical research volunteers and are proud to support CISCRP’s mission during DIA 2018 Global Annual Meeting in Boston. It is our hope that DIA attendees will participate in in this event to honor Medical Heroes and raise awareness for clinical research,” says Sudip S. Parikh, PhD, Senior Vice President and Managing Director, DIA Americas.

This event is being sponsored by Olympiad Sponsor WCG Clinical, Champion Sponsor EMD Serono, Elite Sponsors Artcraft Health and Biogen, Participating Sponsors, The MRN, Amicus Therapeutic, GlobalCare Clinical Trials and Synchrogenix, and Booth Sponsors Synteract, Wegmans, Advanced Clinical, ClinEdge, Veristat, Eurofins and IQVIA. We are also receiving in-kind donations from Trader Joe’s, Starbucks and PR Restaurants.

Donald A. Deieso, PhD, Chairman & CEO of WCG (WIRB-Copernicus Group), the 5K’s Olympiad Sponsor, remarks, “We are honored to support an event that honors study volunteers for their contributions to public health.”

Onsite check-in begins at 6 a.m. and the 5K Run & Walk will begin at 6:30 a.m., following a brief Medical Heroes Recognition Ceremony. Register at http://bit.ly/MH5KBOS18PR. For more information about the event, to volunteer, or to become a sponsor, email [email protected] Questions about event registration should be addressed to Clarissa Budd via phone, 617-725-2750 x321, e-mail [email protected], or call toll free 1-877-MED-HERO x321.

About DIA:
DIA (founded as the Drug Information Association) is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. As a member-driven, volunteer organization, professionals from 80 countries have affected healthcare outcomes, by engaging with DIA through an unparalleled network, educational offerings, and professional development opportunities. To learn more or register for the DIA 2018 Global Annual Meeting, visit DIAglobal.org.