Clinical trial halted because of Brexit, UK Government downplays concerns

pharmafile | October 3, 2018 | News story | Research and Development UK, brexit, clinical trials, politics, research 

A clinical trial looking into the safety and efficacy of the drug dutogliptin has been halted due to uncertainties surrounding Brexit.

The trial, which was being undertaken by US-based research firm Recardio in the British towns and cities of Leeds, Exeter and Clydebank, was stopped due to regulatory concerns associated with Brexit.

Nevertheless the Department of Health have said that the UK would “continue to deliver the best possible environment” for clinical trials, according to the BBC. A spokesperson for the organisation said “We are confident of reaching a deal with the EU that benefits patients and continues to deliver the best possible environment in which to support clinical trials. We want to ensure that patients in the UK and across the EU are still able to access the most innovative and effective medicines.”

Meanwhile the Golden Jubilee Hospital in Clydebank near Glasgow reported that the US based research firm had said “uncertainty due to EU withdrawal” had led to the ending of the trial, and that “completely unresolved” issues with the EMA posed a “significant risk” to the company’s business.

A Scottish government spokesperson commented: “This is the first clinical study we are aware of to be suspended in Scotland as a result of Brexit – and a very concerning sign of what could happen.”

The BBC has suggested that Recardio is concerned as to the validity of data collected in the UK within the EMA regulatory network after Brexit.

However the EMA have stated that it “will continue to accept clinical evidence generated in the United Kingdom” after Brexit assuming that standards are maintained.

Louis Goss

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