March 25, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
AstraZeneca PLC announced on March 19 that it has created a scientific review board to assess requests from external researchers to access patient level data. The board of independent clinicians and academics has been developed as a part of the company’s commitment to the groups including the European Federation of Pharmaceutical Industries and Associations, Pharmaceutical Research and Manufacturers of America Responsible Data Sharing Principles and European Medicines Agency Clinical Trial Policy and Regulation.
Peter Kowey, system chief of the Division of Cardiovascular Diseases for the Lankenau Heart Institute, is the chairman of the board. Other members include Stephen Rennard of the University of Nebraska Medical Center, Simon Day from Clinical Trials Consulting and Training and Alexander Walker from World Health Information Science Consultants.
“I am excited to be leading the Scientific Review Board for AstraZeneca and contributing to furthering transparency for the purposes of developing better drugs to help patients across the globe,” Kowey said.
The board will meet on a regular basis to assess requests for data from AstraZeneca’s clinical trials. They will be responsible for looking at the scientific validity of requests, as well as how they could enhance patient care.
The formation of the board reflects AstraZeneca’s Clinical Trial Transparency Policy, which results in the posting of all results from AstraZeneca sponsored clinical trials.
A Strong Dedication to Transparency
AstraZeneca has a long-standing commitment to making information about its clinical research widely available to the public. Furthermore, the company publishes these results, regardless of whether they reflect favorably on AstraZeneca as a whole.
The company has been posting trial results with already-marked medicines within one year of their completion since 2005. Additionally, AstraZeneca has been publishing data on the U.S. National Library of Medicine’s website since 2007.
However, the company notes on its website that it will continue to consider requests for patient level data on a case-by-case basis. AstraZeneca states that calls for “open access” to clinical data “raise complex practical, legal and ethical issues.”
In 2015, the company claims that it will roll out a data transparency portal, which will allow researchers to submit requests for this sensitive information. It also intends to lay language summaries of clinical trial results, and they will be available to all patients who participate in AstraZeneca sponsored trials.
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