Trial results summaries are intended to communicate the study data in a format and layout that is easy to understand and accessible. They are also known as lay language or plain language summaries.
The summaries also enable transparency and enhance trust and engagement between sponsors, researchers, trial participants, patients and the general public, said PRA Health.
PRA Health added that plain language trial results summaries will become mandatory in the European Union (EU) in the near future.
Under an EU Clinical Trials Regulation, which is set to come into effect 2020, sponsors will have to provide trial results via the European Medicines Agency (EMA) portal and database ‘for laypersons’.
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Trial Results Summaries will be prepared by PRA Health, while CISCRP will deliver them in an easy-to-understand format and ensure the summaries are objective and meet the requirements of participants, patients and the public.
PRA Health Sciences Medical Writing and Clinical Trial Transparency vice-president 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.”
CISCRP will perform the review of all summaries through Editorial Panels comprising public, patients, patient advocates and healthcare specialists.
The company will be responsible for report generation and translation into patient languages, as well as facilitate dissemination to participants across investigative sites.
CISCRP Patient Engagement senior director Jill McNair said: “We are very pleased to be collaborating with PRA to enhance the experience and engagement of their patients.
“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.”
Recently, a study revealed that more than 90% of study participants are interested in knowing the general findings of their trial, but only 11% report receiving the data.
Another study found return of trial results as one of the primary reasons for volunteers to participate.
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