As the debate on data transparency continues, Pfizer has updated its policy "that will simplify and broaden access" to information gathered in its clinical trials.
The drug giant says the move "meets or exceeds" the principles for responsible data sharing issued in July by the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations. Its INSPIIRE public web portal for investigator-initiated research will "offer qualified researchers a standard form and process for requesting access to anonymised patient-level data from Pfizer-sponsored trials of approved (or discontinued) products/indications posted on clinicaltrials.gov that have been complete for 24 months".
Other highlights of the updated policy will see the establishment of an external independent review panel will consider "all requests denied or only partially approved by Pfizer". The company will also produce and distribute lay-language summaries of clinical trial results to participants who wish to receive them, starting with studies that begin enrolling in 2014.
Pfizer is also piloting the use of technology to enable participants to download their own electronic clinical data collected in the trial.
Chief medical officer Freda Lewis-Hall said that 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".
She added that the expanded policy "is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonised process to expand access in ways that protect patient privacy, respect the regulatory process and maintain incentives to conduct new research".
Ireland job cuts
Meantime, days after Merck & Co announced plans to close a plant in Ireland, Pfizer has announced cuts at its site in Co Kildare which will lead to the loss of around 150 jobs.
The redundancies at the Newbridge facility are due to plans to close packaging operations there. Paul Duffy, Pfizer’s vice president of manufacturing for Ireland, noted that the firm has been impacted by patent expiration on a number of key medicines "and increased generic competition has resulted in a reduction in manufacturing volumes and an excess of manufacturing capacity globally, and in Ireland specifically".
This means that "we must rescale our operations to better align with the future needs of our business and also to achieve greater competitiveness", he added. Mr Duffy stressed that "Ireland remains a key strategic location for Pfizer" with many of its leading and newest medicines manufactured in the country and the company will continue to make investments in Irish operations.
