The Department of Health's response to the campaign about transparency in clinical trials.
The government supports the call for more transparency in clinical trial data. Transparency is important for patients, the public, researchers and the NHS, and can be achieved through ensuring that all clinical trials are registered on a public database such as the EU Clinical Trials Register. This means that everybody can see what trials are ongoing, the results of all clinical trials are published, and data from all clinical trials are made available.
Before a clinical trial can begin in England, it must be approved by an independent ethics committee. Since 30 September, one of the conditions for approval has been that the trial is registered on a publically accessible database.
In its proposal for a Clinical Trials Regulation (2012/0192), the European Commission calls for a publically accessible EU database. This database will contain details of all trials submitted for authorisation in the EU and summaries of their results within one year after they have ended. The government is supportive of these proposals.
In the negotiation of the Clinical Trials Regulation, the European Parliament has opted for even more transparency and would like clinical study reports that have been submitted in support of a marketing authorisation to be published on the EU database by the Marketing Authorisation Holders within 30 days after a regulatory decision has been made.
The government also agrees with the European Parliament that once a regulatory decision has been made, the data in clinical study reports should not be considered commercially confidential. The government thinks it is important that there is clarity about the data that should be included in clinical study reports to ensure that trial sponsors as well as the public can be reassured.