BOSTON, Feb. 28, 2019 /PRNewswire-PRWeb/ -- A key focus for both parties is to provide a more positive overall experience
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 translation 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 http://www.prahs.com.
SOURCE CISCRP (Center for Information and Study on Clinical Research Participation)
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