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UK to require public clinical trial registration from end of September


The UK's health research regulatory body on Tuesday said it will require from the end of this month, all clinical trials to be registered in a publicly accessible database for them to be granted ethical approval.

The Health Research Authority (HRA), in its response to a report from the cross-party Science and Technology Committee, pointed to an announcement last week that failure to register on such a database will be considered a breach of good research practice.

The committee's report repeated calls for more public scrutiny of clinical research, following calls from campaigners such as doctor and journalist, Ben Goldacre.

In a statement, the HRA said the new rules will come into effect from September 30. Sponsors may contest the need for registration but in the statement the HRA said it did not "expect exceptions to be made".

Trials needing such registrations fall into four categories: investigational drugs, medical devices, combinations of drugs and devices and novel interventions or comparative trials of existing interventions.

All studies will need to be registered before the first patient is recruited, it added. Previously, approved studies must also be registered on the database, according to the statement, which provided no further guidance on this particular point.

However, a spokesperson for the Association of the British Pharmaceutical Industry (ABPI) said in a statement that the trade body's existing code of practice already requires pharma companies to register clinical trials in the public domain.

When approached by APM for comment on the issue of clinical trial bureaucracy that was raised in the report, a spokesperson pointed to HRA projects outlined in newsletters published on its website.

A feasibility study for a single HRA assessment for clinical trial approvals, replacing multiple approvals for each NHS organisation involved, has been completed, according to the website.

The HRA has also identified areas to tackle to eliminate duplication and inefficiency in approvals, according to the website.

Costed options over how to implement the single assessment will be presented to the HRA's board at the end of September, according to the statement.


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