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Pfizer’s open data policy should include trials of off-label uses, say critics

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f7327 (Published 06 December 2013) Cite this as: BMJ 2013;347:f7327
  1. Zosia Kmietowicz
  1. 1BMJ

A commitment from the pharmaceutical giant Pfizer to extend access to the data it holds on drug trials in patients has been criticised for excluding studies of unlicensed uses.

On 4 December Pfizer announced that it was updating its clinical trial access policy, claiming that the move would “simplify and broaden access to information gathered in Pfizer-sponsored clinical trials.”1

From 1 January 2014, the company said, researchers will be able to apply to access anonymised, patient level data of approved or discontinued products posted on clinicaltrials.gov 24 months after trials have been completed.

But the doctor and author of Bad Pharma, Ben Goldacre, said that excluding off-label studies from transparency was “a senseless loophole.”

He said that so far Pfizer had been fined for promoting unlicensed uses …

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