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Clinical trials

Brexit shouldn’t affect plans for new clinical trials regulations, conference hears

Brexit is unlikely to result in any major changes to the implementation of the EU Clinical Trials Directive, Elizabeth Allen, a senior clinical trials researcher, told delegates at the Royal Pharmaceutical Society (RPS) annual conference in Birmingham on 5 September 2016.

Allen, who is president of phase I research at Quintiles Drug Research Unit at Guy’s Hospital, London, said that her organisation had been told there will probably be no major changes to how the UK implements the directive and to “carry on as normal”. However, she did not specify the source of this information.

The new EU Clinical Trials Directive is due to be transposed from EU to UK law in 2018. However, there has been uncertainty about how the UK would treat upcoming EU legislation since the referendum vote to leave the EU. The government says it is assessing the impact of Brexit on UK regulations and will carry on as normal in the meantime, but it encourages contributions to an ongoing consultation on implementation of the regulations.

Allen’s speech at the RPS conference focused on new methods for running clinical trials and improving their cost efficiency, which has become increasingly important as new medicines become more personalised, meaning that they are usually effective for only a subpopulation of patients.

The EU Clinical Trials Directive, which contains new rules that aim to improve transparency of clinical trials and their results, is aimed to streamline the authorisation process for new medicines and harmonise the rules for clinical trials across Europe. She explained that any variation in the regulatory environment increases the cost of running clinical trials in the EU, reporting that the average cost of bringing a drug to market has now gone up to US$2.6bn.

Each EU member state translates the directive into its own national law, which can lead to variation in how the directive is interpreted, nonetheless Allen said that “it should make everyone’s lives easier”.

The UK’s version in particular contains new rules that aim to improve transparency of clinical trials and their results. Transparency has been the subject of an ongoing campaign called Alltrials by the charity Sense About Science, which says all clinical trial results should be publicly available. This includes current and future clinical trials as well as past clinical trials for which results were never published.

Also speaking at the conference, Sile Lane, director of campaigns and policy at Sense about Science, said that the new directive would ensure that almost all trials conducted in Europe would need to be registered and the results made available within a year. Addressing the potential uncertainty after Brexit, she said she would encourage everyone to contribute to the ongoing consultation and advocate for the transparency clauses to still become UK law.

Lane added that GlaxoSmithKline, a notable supporter of the Alltrials campaign, has developed a portal for publishing data from past clinical trials, to which researchers have access. The portal is now available for other companies to use and a further ten companies have signed up. It is now being managed by the Wellcome Trust.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201681

Readers' comments (1)

  • The new Clinical Trials REGULATION does NOT require to be transposed into UK law! The current Clinical Trials DIRECTIVE did require transposition into national law and, therein, lay the problem (of differences in interpretation and application)... See key changes (p2) here:

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