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By Bill Berkrot
NEW YORK, Dec 4 (Reuters) - Global drugmaker Pfizer Inc will broaden access to information from its scores ofclinical trials to independent researchers and to patients whotake part in the studies, the company said on Wednesday.
Pfizer, the largest U.S. pharmaceutical company, said ithoped the enhanced access to its data will help spur furtherscientific and medical research as well as encourage morepatients to get involved in clinical trials.
"We are impressed to see how active patients areindividually to manage and understand their disease, and inpatient foundations a tremendous, great job is made tocontribute to the advance of care," Pfizer research chief MikaelDolsten told reporters at the company's New York headquarters."We think this is the right time to support this trend."
The move comes at a time of increasing pressure on thepharmaceutical industry to be more transparent with clinicaltrial information - including safety data and details of failedstudies - and to increase access for the scientific community.
European health regulators announced a plan to startpublishing clinical trial data submitted by companies seekingnew drug approvals from next year, a move opposed by somedrugmakers. Britain's GlaxoSmithKline has set up anonline system to provide researchers with access to anonymouspatient-level data about its medicines.
Pfizer has gone a step further by allowing trial patientsthemselves to access its data.
"We are proud to be, I think, the first company to take thisstep," Dolsten said.
Under the new initiative, Pfizer will makeeasy-to-understand summaries of its trial results available tostudy participants who want to receive them, beginning in 2014.
Pfizer will also allow trial participants to download all oftheir own personal data gleaned during the study.
That would for the first time give them access to personalmedical information tracked by researchers over the course ofthe trial, which is far more detailed than simply their responseto the study drug or placebo. The information could help doctorsand patients make more informed treatment decisions to addresshealth problems, the company said.
"We've had patients ask for information for many, many yearsand I think one way of making them feel that the value that theybrought to the whole development process is in fact recognizedis to get information back to them," said Steve Romano, head ofPfizer's medicines development group and specialty care unit.
"As far as changing the mindset of patients getting involvedin clinical trials, which has always been a challenge, this willhelp quite a bit," Romano predicted.
Enrolling enough subjects into large clinical trials ofexperimental medicines and devices, an industry-wide problem,can cause delays in completing important studies and add monthsor years to the time it takes to bring new products to market.
For the scientific and medical researchers, Pfizer said itwould consider requests for access to its trial information andmake the anonymous patient data available for what it sees ashigh-quality scientific reviews.
To enhance the transparency of the process, Pfizer will setup an independent review panel of academic scientists with thepower to override a Pfizer veto or partial approval of clinicaldata access to researchers. The panel, not the company, wouldmake the final decision, Pfizer said.
