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The Editors blog

An inside look at what’s happening within the pharma industry and across the PMGroup from the PMLiVE editorial team

Singing a simple song?

As the EMA consultation on clinical trial data closes, what next in the transparency debate?
simple song

You should expect the background noise about clinical trial transparency to reach a crescendo over the coming months as January 2014 rapidly approaches.

Then, all going to plan, the EMA will count in the start of its yet-to-be-finalised policy on publication and access to clinical trial information. But will the changes bring discord or harmony?

Already lending their voices to the chorus in support of the policy are European pharmacists and, more strikingly, IQWiG. 

The German HTA body not only supports the EMA's plans to make trial data available to researchers on a tiered basis, but it recently struck up a solo calling for all clinical study reports (CSRs) to be released.

The EMA is now finalising its policy ahead of its formal adoption in December. But January 1 is unlikely to be the end of the issue, and now is the time for pharma to decide what song it wants to sing in 2014.

Before then we should hope the promised “implementation plan” for the policy can make an uptempo entrance.

This article first appeared as the editor's comment in PME October 2013

Article by
Dominic Tyer

editorial director of PMGroup

22nd October 2013

From: Research, Regulatory



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