Northern Ireland trials of a potentially life-saving cancer test have faced significant delays with EU rules were wrongly blamed for the hold-up.
The Department of Health has now admitted there is nothing in EU regulations to prevent the trials being conducted here, despite an earlier assertion that EU compliance issues were to blame for the tests not taking place locally.
The ‘sponge on a string’ test can give an early warning of oesophageal cancer and has already been approved for clinical trials in other parts of the UK.
It is hoped the test will save thousands of lives as early diagnosis is crucial for oesophageal cancer. Currently there is only a one in five survival rate for the disease with 80% of cases detected at a late stage.
Less invasive and cheaper than an endoscopy (camera down the throat), the test works by asking patients with persistent heartburn to swallow a pill attached to a string that expands into a sponge in the stomach.
When retrieved, it picks up cells in the food pipe which can detect an abnormality known as Barett’s oesophagus – which indicates they are more likely to develop oesophageal cancer.
Earlier this month, Mike Nesbitt told the Alliance MLA Stewart Dickson the trial could not take place in Northern Ireland because of EU compliance issues.
Belfast Trust first received the application for the trial in October 2024, but could not proceed without approval from the Public Health Agency.
But in an update to Mr Dickson this week, the Health Minister said blaming a clash with EU rules was not correct after all.
“I appreciate your interest in NI’s participation in this valuable UK study into a quick and simple way to check the health of the oesophagus,” he said.
“I am pleased to inform you that the Medicines and Healthcare products Regulatory Agency (MHRA) has clarified that there are no EU In Vitro Diagnostic….regulatory reasons to prevent NI from participating in the BEST4 study.
“This follows positive engagement between my officials, other NI stakeholders and the MHRA.
“As a result, the Belfast Health and Social Care trust is now able to proceed with participation in the BEST4 study, subject to completion of its own internal governance processes and agreement of any contractual requirements with the study sponsor.”
A spokesperson from the Department of Health added: “It is not unusual for studies to take time to be approved due to the complexities of trials and the various issues that can arise.
“EU IVDR legislation applies in NI which means additional details may need to be considered prior to studies being initiated at NI sites.
“Clarification was sought to understand if some aspects of this study were required to follow EU IVDR requirements.
“Following positive engagement between my Department, other NI stakeholders and the Medicines and Healthcare products Regulatory Agency (MHRA) last week, the MHRA confirmed additional EU IVDR regulatory considerations would not apply to this study.
“NI Health Trusts may participate subject to their own internal approvals process and contractual arrangements with the study sponsor.
“Whilst I understand the concern any delays may have caused, it is important to note that this is a comparative study and does not impact on the treatment or diagnosis of cancer patients in NI.”
Alliance Party MLA Stewart Dickson
Speaking to the Irish News, Mr Dickson said he was glad the trial should be able to continue but called the delays “very disappointing”.
“I think (the health minister) was hoping I was going to be satisfied with what he said, and while I welcome the fact things were clarified…I really do need to understand where the minister was coming from in the first instance,” he said.
“He was clearly badly advised, and if that’s the advice he was given about this test – how many other clinical trials are in exactly the same situation?
“We’re moving towards the all’s well that ends well, but basically we were sent off in completely the wrong direction.
“We had academics scratching their heads and saying ‘what EU approval do we need?’.
“And then they come back and say ‘sorry that’s not the case’. The left hand doesn’t know what the right hand’s doing. It’s very disappointing, but more importantly these are peoples’ lives that are being played with.”