BMJ to bar papers when patient-level data kept private

Share this article:
Fiona Godlee
Fiona Godlee

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.”
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.