Pfizer outlines more open clinical data access policy

Pfizer has announced an expansion of its clinical trial data access policy that will provide greater openness and transparency when it comes into effect on January 1st 2014.

The updated policy coincides with the launch of the new Inspiire public web portal for investigator-initiated research, which will provide qualified researchers with a standard form and process for requesting access to anonymised patient-level data from Pfizer-sponsored trials.

An external independent review panel will consider all access requests denied or only partially approved by Pfizer, while synopses of clinical study reports filed with regulatory agencies for approved products will be published on the company's website.

Finally, lay-language summaries of clinical study results will be offered to trial participants who request them, with Blue Button technology to be piloted in order to help patients download their own electronic clinical data collected in the trial.

Dr Freda Lewis-Hall, Pfizer's executive vice-president and chief medical officer, said: "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."

This comes as part of an industry-wide movement towards greater clinical data transparency, with companies such as GlaxoSmithKline and Roche having already moved to make their data more accessible.