Regulatory Focus™ > News Articles > UK Moves to Implement New Clinical Trial Registry Requirements

UK Moves to Implement New Clinical Trial Registry Requirements

Posted 11 September 2013 | By

The UK's Health Research Authority (HRA), a relatively new addition to the National Health Service (NHS) tasked with protecting and promoting the interests of the public in health research, has announced a new clinical research transparency policy that will require the registration of a trial in order to obtain approval from Research Ethics Committees (RECs).

Background

The EU-as well as other regions-is currently in the midst of heated debate regarding whether data obtained from clinical trials used to support the approval of pharmaceutical and biological products should be made publicly available after the conclusion of the trial.

At present, some companies are beginning to release data on a voluntary and controlled basis. New guidelines released jointly by the industry groups EFPIA and PhRMA have called for a framework in which "qualified scientific and medical researchers" can be granted access to data, and all member companies in those two organizations have signed on to the plan.

However, the European Medicines Agency (EMA) is now considering a plan that would go considerably farther than the industry-touted plan, raising the prospect that companies would have to make full data sets available to the public, including the data protocols. Industry members have meanwhile sued EMA to halt the plan, arguing it infringes upon their commercially confidential information and trade secrets.

But as a new proposal from HRA shows, there's much to be done with respect to clinical trial transparency that falls short of either industry- or regulatory-sponsored plans.

New Registry Requirements

In an 11 September 2013 announcement, HRA said it will soon require all trials conducted in the UK be registered. Failure to do so, it said, would cause the trial to be in breach of good research practice, "in linewith other breaches."

The requirements will apply to all clinical trials of an investigational medicinal product (including medical devices, drugs or clinical interventions). The registration will have to occur within six weeks of the first patient recruitment for most studies, though medical devices will be held to a slightly different timeline for the time being. HRA said it would consult with the device industry to harmonize requirements by March 2014.

The biggest change of all, however, may be the proposal's scope. HRA said it would apply not just to future studies, but to ongoing and previously conducted ones as well. No range was given for registration, leaving it possible that decades worth of studies may need to be reported.

In addition, HRA said that trial results are expected to "be put in the public domain." Again, details were vague about what HRA determines to be "results." Similar trial registries in the US and Canada simply require top-line results for the trial to be published, while EMA is now pushing for all results.

Focus has reached out to HRA staff for clarification and additional details, and will update this piece when we hear more.


HRA Statement


Tags: UK

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