New cardiac monitoring technology could save the lives of human drug guinea pigs who develop heart problems during clinical trials, its UK developer has claimed.
However, Cardionetics admitted the cost of equipping patients with its devices was likely to deter pharmaceutical companies, leading to tragic results for the small number who develop serious side effects during the testing of new medicines.
Cardionetics, a specialist in portable electrocardiogram (ECG) monitoring equipment, said it would soon be practical to remotely check the hearts of people taking part in trials of new pharmaceutical products.
The company is planning to build remote monitoring facilities into new versions of its device, which uses neural networking technology to provide round-the-clock analysis of cardiac patients.
Because it processes the data internally rather than relying on an external computer, it can provide regular reports on a patient’s condition without the need to hook them up to a full-scale ECG system.
Philip Needham, chief technology officer for Cardionetics, said that extending its use to those taking part in drug trials would undoubtedly save lives.
The US Food and Drug Administration – the world’s most powerful regulator of new drugs – explored the idea of providing trial patients with the technology after a few suffered disastrous reactions.
’Some drug trials have been stopped because in a small number of cases the side-effects of the drug were causing severe heart problems and killing people,’ said Needham.
However, he said that although the technology made continuous monitoring practical, there were commercial obstacles.
’Commercially it is a difficult proposition,’ said Needham. ’You are adding to the cost of the trial to look for adverse effects on a small number of people. Of course, for those who do have problems it is a very big issue.
’The FDA would like to do it and the drug companies know they should do it, but it is a cost/benefit equation,’ added Needham.
Hampshire-based Cardionetics was set up to commercialise neural networks technology first developed by Brunel University.
Neural networks process information through mathematical models based on complex, interconnected structures similar to the human brain. This makes them particularly well suited to pattern analysis – they are used in biometric technologies such facial and voice analysis and for interpreting medical data.
Brunel transferred to Cardionetics its global patents on the use of neural networks in portable ECG monitoring equipment.
Its devices are used by GPs and hospitals to carry out initial assessments of patients with symptoms that point to possible heart problems.
Needham said the system was so sensitive it would pick up the effect on the heart of ’a couple of cups of coffee.’