Plain language trial results will become mandatory for studies conducted in the EU under the EU Clinical Trials Regulation No 536/2014, which is expected to come into effect in 2020. This act will require sponsors to provide trial results through the European Medicines Agency (EMA) portal and database.
Under its agreement with the Center for Information and Study on Clinical Research Participation (CISCRP), PRA’s medical writers will draft the trial results summaries and CISCRP will coordinate the review of all summaries through its Editorial Panels. These panels will be composed of members of the public as well as patients, patient advocates, and health care specialists in the therapeutic area of the study.
CISCRP also will manage translation into patient languages and facilitate the dissemination to participants through investigative sites.
Jill McNair, senior director of Patient Engagement at CISCRP said in a statement, “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.”
According to PRA, approximately 11% of participants currently receive trial results, despite studies showing that a majority of want to know what has been learned from the trial.
PRA Health Services has not responded to a request for comment.