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
No results were found
Nucleus Global is the largest specialist medical communications network in the world. Globally, we have over 950 experts delivering world-class...