Publication of Clinical Trial Data - new rules

For the last five years it has been possible to request access to view certain clinical trial data submitted under the centralised procedure however new rules effective as of 1st January mean that the EMA will proactively publish data.  The idea is that the wider availability of the data will increase confidence in the medicine approval process and will allow other groups to  review and understand what has been done.  This may lead to third party analysis that will reveal hidden results say relating to efficacy or side effects in sub groups of the population or to better designed or more efficient future trials.  The new procedure will not apply proactively or to individual case safety reports but will apply to situations where the EMA has requested additional data including post authorisation studies.

The material published will be redacted to avoid disclosure of anything that could identify individual patients or company confidential information.  Initially only the summary reports for new applications are to be published but from July extensions will also be covered.  The legislation provides for publication of the individual patient data too but implementation of this last is on hold pending the authorities being satisfied that that the rights of the patients involved to anonymity can be effectively protected.

In order to access the published data parties will have to register and agree to certain terms of use.  There will be two categories of user – a simple registration will allow online access while a more detailed registration will permit download of the data.  Users will not be permitted to use the material to support their own product registrations and will have to agree not to attempt to identify individual patents or to breach intellectual property rights.

Many companies already voluntarily publish much of this material but those running clinical trials for third parties ( especially non European entities) should make sure that their clients understand the nature of the new publication rules and that this is covered in their contracts

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