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.