english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2014 Recap > Clinical trial data disclosure policy in the US (4/2014)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

A recap of actions in 2014
Clinical trial data disclosure protects the public from preventable harm (April 2014)

Brussels, 4 April 2014

In their Joint Response to a consultation by the US Institute of Medicine (IOM), HAI Europe, ISDB, MiEF and TACD encourage the active implementation of a data sharing policy that ensures full public access to clinical data in the US, in alignment with the new European requirements.

> Click here to download the Joint Response (pdf, 359 Ko)

This consultation on the "Discussion Framework for Clinical Trial Data Sharing, Specific Topics for Public Feedback" represents an opportunity for the IOM to develop guidelines for full transparency and access to clinical data held by drug regulatory authorities.

Public access to clinical trial data is particularly important to protect public health as it allows for independent analysis, enhancing knowledge about the real effects of medicines and allowing comparative effectiveness reviews.

In our response, we first focus on the general principles underpinning the need for clinical data disclosure and then provide insight into aspects relating to privacy and confidentiality, unfounded claims of potential data misuse, as well as how to enhance incentives and measure impact.

We encourage the IOM to commit to the active implementation of a data sharing policy that ensures full public access to clinical data and puts public health ahead of commercial interests. 

©HAI Europe, ISDB, MiEF, TACD April 2014

> Click here to download the Joint Response (pdf, 359 Ko)