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Last Updated Saturday, April 19 2014

Pfizer Opens Up Clinical Trial Data Policy

Published December 5, 2013
Pfizer has updated its clinical trial data access policy with the goal of simplifying and broadening access to information gathered from clinical trials. The updated policy expands the company's established methods of clinical trial information sharing, including publication of results from all interventional clinical trials in patients, and its efforts to provide clinical trial results and medical data to study participants.
Pfizer's expanded policy, effective January 1, 2014, includes elements such as the INSPIIRE public web portal for investigator-initiated research, and an external Independent Review Panel. Additionally, Pfizer will publish a “layman-friendly” synopses of clinical study reports (CSRs) filed with regulatory agencies on its website, and will produce and distribute summaries of clinical trial results and individual medical data to trial participants who wish to receive them. Pfizer is also piloting the use of “Blue Button” technology, launched by the U.S. Departments of Veterans Affairs and Health and Human Services, to enable trial participants to download their own electronic clinical data to share with their physicians.
The program will enable qualified researchers to request trial data from Pfizer on a case-by-case basis. If Pfizer refuses the request, it can be overruled by an independent review panel.
“Increasing use of new analytical tools and processes to better understand patient outcomes suggests that broadening access to information from clinical trials, including patient-level data, when done responsibly, may benefit medical research and public health,” said Freda Lewis-Hall, M.D., Pfizer's executive vice president and chief medical officer. “Pfizer's expanded policy is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonized process to expand access in ways that protect patient privacy, respect the regulatory process and maintain incentives to conduct new research.”
Pfizer's updated policy meets the “Principles for Responsible Data Sharing” issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) in July 2013.

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