PRA Health Sciences and CISCRP Collaborate to Provide Clinical Trial Results Summaries to Patients and the Public
February 25 2019 - 10:20AM
PRA Health Sciences and the non-profit Center for Information and
Study on Clinical Research Participation (CISCRP) are pleased to
announce that they are collaborating to prepare and deliver Trial
Results Summaries to study volunteers. A key focus for PRA 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 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 www.prahs.com.
INVESTOR INQUIRIES: InvestorRelations@prahs.com
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