PRA teams with CISCRP for trial result summaries

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/dragana991)
(Image: Getty/dragana991)

Related tags: Pra, Pra health sciences, Clinical trial, Clinical trial data, Clinical trial management, Patient centricity, patient engagement, Patient outcomes

PRA Health Sciences is collaborating with CISCRP to provide patients with soon to be mandatory clinical trial result summaries.

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. 

Related news

Show more

Related products

RACE Act Prompts Pediatric Oncology Trials

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Global Clinical Trial Lab Services

Global Clinical Trial Lab Services

Q2 Solutions | 01-Apr-2020 | Product Presentation

As a leading global lab services partner, we provide operational excellence, scientific leadership and innovation through technology. We offer end-to-end...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 01-Mar-2020 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

What do big pharma companies spend on R&D?

What do big pharma companies spend on R&D?

Zymewire | 15-Aug-2019 | Technical / White Paper

The free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies...

Related suppliers

Follow us

Products

View more

Webinars