Starting next year, the BMJ will not publish academic papers on drugs or devices unless the relevant anonymized patient-level data are made available for third-party study.
The journal, which announced the policy October 30, will require this commitment for all clinical trials of drugs and devices starting in January 2013.
In an editorial, Fiona Godlee, BMJ’s editor in chief, said that the fact that such data are kept private has made it harder to assess drug safety and efficacy.
The journal’s show of power is the latest attempt to get drugmakers to take the wraps off data. Earlier this year, Cochrane Collaboration researchers accused Roche of author bias in the trial program for Tamiflu.
When patient-level clinical research data are made available for independent scrutiny, academics and companies say, better treatment decisions about drugs can be made.
While this data is often withheld by industry, some have pledged to open up. Medtronic has pledged to release all relevant clinical research data into the public domain in a partnership with Yale University, and GlaxoSmithKline in October said that it would make such data available from its trials.
In a statement, GSK’s Patrick Vallance, president, pharmaceuticals R&D, noted, “Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines.”
From the December 01, 2012 Issue of MM+M - Medical Marketing and Media
