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A US medical research company has halted the recruitment of UK patients to a global clinical trial, with the NHS hospital involved saying it was stopped because of uncertainty over Brexit.
Recardio told one of the UK recruiting centres via email on 17 September 2018 that it was suspending the recruitment of UK patients to its trial involving the drug dutogliptin because of unresolved issues over the UK’s withdrawal from the EU.
The California-based company said that it was still unclear which clinical trial documentation and assurances the European Medicines Agency (EMA) would require from the UK once it left the EU in March 2019.
A statement from the Golden Jubilee National Hospital, near Glasgow, said: “Recardio advised our team at the Golden Jubilee Research Institute via email that one of their research studies has been put on hold in the UK.
“According to the company, uncertainty due to EU withdrawal, particularly drug and data release to the EMA, are completely unresolved and represent a significant risk. However, this may change when the regulatory situation has clarity.”
The hospital admitted that it was “disappointed” by the decision.
According to the NHS register of clinical trials, Recardio is currently carrying out a phase II randomised double-blind trial involving dutogliptin given in combination with filgrastim in the early recovery of patients post-myocardial infarction.
The UK clinical trials gateway identifies three UK locations for patient recruitment — Leeds, Exeter and Clydebank — but the website confirms that the company is “not recruiting”.
However, the similar clinical trial database held by the EMA confirms that patient recruitment is underway and that patients from Hungary, Austria and Belgium are already on board.
The move prompted the Association of the British Pharmaceutical Industry (ABPI) to reiterate the need for a Brexit deal, which guarantees the UK’s continued place in clinical trials.
Sheuli Porkess, deputy chief scientific officer at the ABPI, said: “Clinical trials are critical to both the success of the NHS and ensuring we develop new medicines for the future. It is absolutely vital that we agree a Brexit deal to maintain the skills, resources and investment into UK clinical trials, which will benefit thousands of patients.”
A statement from the UK Department of Health and Social Care 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.”
Recardio was unavailable for comment on 4 October 2018.
