New UK rule: sponsors must log trials in public database for ethical approval

Last week the Health Research Authority (HRA) – whose remit is to protect patients in research – said that, from September 30, registering trials in a public database “will be a condition of favourable ethical opinion​.”

The requirement applies to trials of investigational medicinal products, medical devices as well as studies combining the two and – for drug studies - must be completed within six weeks of the recruitment of the first patient. Studies meeting these critera that are not registered will be deemed to be in breach of good research practice.

In its statement the HRA said it recognized that other types of studies should be also registered but “further consideration is required given the range of studies review in the UK​.”

“The HRA is putting in place plans to update the applicant and sponsor declaration on new studies, to declare that previous studies have been registered and published. The HRA expects to update the declaration in early 2014 as a further mechanism to ensure research transparency​.”

Transparency​

The new HRA scheme is part of a wider European effort to make clinical research more transparent​ amid criticism that pharmaceutical industry sponsors​ routinely withhold data from trials that do not yield favourable results for their products.

Given this background – and the repeated suggestions from industry that publishing data from all trials will somehow impact on patient​ rights – we asked the Association of the British Pharmaceutical Industry (ABPI) for its take on the new HRA plan.

The industry group told in-Pharmatechnologist.com that: “The decision to conduct clinical research in the UK is up to individual companies but we think the HRA requirement is unlikely to significantly affect the attractiveness of the UK as a location.​ 

The ABPI also explained that members companies must already register studies in accordance with the IFPMA joint position on the disclosure of clinical trial Information and added that it has recently launched a trial disclosure kit to help through the process.

HRA spokesman Gordon Harrison told in-Pharmatechnologist.com that: “As an organisation, we are working to make the UK a global leader for health research​.”

He explained that: “We are working closely with a number of partners, which as you would expect includes industry representatives, to make sure the UK becomes more attractive as a destination for research, not less​.”