EMA Adopts Publication of Clinical Trial Data

October 2, 2014

The EMA press release issued states: "According to the policy?s terms of use, the public can either browse or search the data on screen, or download, print and save the information. The reports cannot be used for commercial purposes. In general, the clinical reports do not contain commercially confidential information.

The EMA announced it will publish clinical reports, and that requirement will be begin January 1, 2015. EMA expects the new policy to increase trust in its regulatory work as it will allow the general public to better understand the Agency’s decision-making. In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines. 

The EMA press release issued states: "According to the policy’s terms of use, the public can either browse or search the data on screen, or download, print and save the information. The reports cannot be used for commercial purposes. In general, the clinical reports do not contain commercially confidential information. Information that, in limited instances, may be considered commercially confidential will be redacted. The redaction will be made in accordance with principles outlined in the policy’s annexes. The decision on such redactions lies with the Agency."

Further, in a Q&A on the topic, the EMA will implement the policy in a stepwise approach as follows:

  • The first phase concerns the publication of clinical reports only. The Agency has defined a process for publication of clinical reports whereby the data that will be accessible on the EMA website are module 2.5 (clinical overview), module 2.7 (clinical summary), module 5 (clinical study reports (CSRs) and appendices 16.1.1 (protocol and protocol amendments), 16.1.2 (sample case report form) and 16.1.9 (documentation of statistical methods)). Such data either use the common technical document (CTD) format or another format.

  • In a second phase, the Agency will endeavour to find the most appropriate way to make Individual Patient Data (IPD) available, in compliance with privacy and data protection laws. This will involve consultation with stakeholders on various aspects in relation to IPD. More information on this consultation process will be provided at a later stage.

The full draft is available on the EMA site.

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