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 Under the agreement, the "Yale Open Data Access
Project," will independently review and make final decisions
regarding all requests for information on the company's drug
clinical trials, including anonymous patient data.
The action comes amid growing pressure from outside scientists for
access to raw data from clinical trials, reflecting general concerns
that too many studies cannot be independently confirmed and may well
be wrong.
J&J, which sells drugs including blood thinner Xarelto and prostate
cancer treatment Zytiga, said it is in the process of determining
how best to share trial data from its other two areas of operation:
medical devices and consumer products.
"This is a multiyear effort on our part to try to contribute to
advancing medical knowledge and science," Joanne Waldstreicher,
J&J's chief medical officer, said in a telephone interview.
Others drugmakers have made similar moves. Britain's GlaxoSmithkline
Plc has set up an online system to provide researchers with access
to anonymous patient-level data about its medicines.
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Pfizer Inc said in December it would broaden access to information
from its clinical trials to independent researchers and to patients
who take part in the studies. Pfizer also set up an independent review panel of academic
scientists to decide which researcher requests it would answer.
(Reporting by Deena Beasley; editing by
David Gregorio)
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