By Bill Berkrot
NEW YORK, Dec 4 (Reuters) – Global drugmaker Pfizer Inc
will broaden access to information from its scores of
clinical trials to independent researchers and to patients who
take part in the studies, the company said on Wednesday.
Pfizer, the largest U.S. pharmaceutical company, said it
hoped the enhanced access to its data will help spur further
scientific and medical research as well as encourage more
patients to get involved in clinical trials.
“We are impressed to see how active patients are
individually to manage and understand their disease, and in
patient foundations a tremendous, great job is made to
contribute to the advance of care,” Pfizer research chief Mikael
Dolsten 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 the
pharmaceutical industry to be more transparent with clinical
trial information – including safety data and details of failed
studies – and to increase access for the scientific community.
European health regulators announced a plan to start
publishing clinical trial data submitted by companies seeking
new drug approvals from next year, a move opposed by some
drugmakers. Britain’s GlaxoSmithKline has set up an
online system to provide researchers with access to anonymous
patient-level data about its medicines.
Pfizer has gone a step further by allowing trial patients
themselves to access its data.
“We are proud to be, I think, the first company to take this
step,” Dolsten said.
Under the new initiative, Pfizer will make
easy-to-understand summaries of its trial results available to
study participants who want to receive them, beginning in 2014.
Pfizer will also allow trial participants to download all of
their own personal data gleaned during the study.
That would for the first time give them access to personal
medical information tracked by researchers over the course of
the trial, which is far more detailed than simply their response
to the study drug or placebo. The information could help doctors
and patients make more informed treatment decisions to address
health problems, the company said.
“We’ve had patients ask for information for many, many years
and I think one way of making them feel that the value that they
brought to the whole development process is in fact recognized
is to get information back to them,” said Steve Romano, head of
Pfizer’s medicines development group and specialty care unit.
“As far as changing the mindset of patients getting involved
in clinical trials, which has always been a challenge, this will
help quite a bit,” Romano predicted.
Enrolling enough subjects into large clinical trials of
experimental medicines and devices, an industry-wide problem,
can cause delays in completing important studies and add months
or years to the time it takes to bring new products to market.
For the scientific and medical researchers, Pfizer said it
would consider requests for access to its trial information and
make the anonymous patient data available for what it sees as
high-quality scientific reviews.
To enhance the transparency of the process, Pfizer will set
up an independent review panel of academic scientists with the
power to override a Pfizer veto or partial approval of clinical
data access to researchers. The panel, not the company, would
make the final decision, Pfizer said.
