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EMA publishes guidance on trial data publishing

By Gareth Macdonald , 23-Oct-2012
Last updated on 05-Nov-2012 at 16:14 GMT2012-11-05T16:14:53Z

EMA sets out clinical data disclosure rules

The EMA has issued new guidance on the publication of clinical trial results as part of an effort to make such data publicly available.

The guidance - published in the journal of the European Union – sets out how pharma sponsors should post trial data to the EudraCT database, directing them to use the same format at the US site with certain caveats relating to the EU Paediatric Investigation Plan (PIP).

Under the regulations sponsors or contract research organisations (CRO) will be given a secure account through which they can upload data, while the EMA will be responsible for making the information publicly available.

The posted result-related information is made public through the EU Clinical Trials Register of EudraPharm in accordance with the Commission guidance documents” the EMA said, adding that only result-related information on non-paediatric Phase-I clinical trials will not be made public.

Data will be posted within 15 working days in combination with the protocol for the trial from which it is derived. The EMA will also be responsible for announcing that the results of a particular study have been made public.

In addition, the results of trials that ended one year before the database went live must be uploaded within one year, whereas studies that were completed earlier than that should be added within two years either via the online system or as a pdf file.

Accuracy and compliance

The European member state where the trial takes place will be responsible for ensuring that clinical data are uploaded to EudraCT.

Any data that is not reported within specified periods – nine months for paediatric studies and 15 months for all other trials – will be flagged and the existing protocol information as well as the expected duration of the research will be made public

Similarly, any trial found not to have been conducted according to good clinical practice (GCP) requirements will be removed from public view, highlighted as invalid by the EMA and non-compliance will be recorded in the public record.

Public data

The publication follows just a few weeks after the EMA called for contract research organisation (CRO) and sponsor feedback on its plans to publish trial data and just a few months after it detailed its proposals in a concept paper .

It also follows just a few weeks after the US Food and Drug Administration (FDA) took charge of as part of an effort to increase the amount and quality of data uploaded to the database. 

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