Irish researchers argue for more clinical drug trials

Ireland has not always been at the forefront of attracting clinical trials, but with cases of many types of chronic disease expected to double in this country by 2040, there has been a renewed effort to bring such programmes – and the “designer” drugs that come with them – to these shores.

The State’s ageing population profile means many will be confronted with the spectre of serious illness over the coming decades.

Clinicians see this as a good juncture to introduce new medications that could provide an economic boost for the health service.

Despite hosting operations for many of world’s leading pharmaceutical manufacturers, there were only about 200 clinical trials of all varieties either recruiting or open in Ireland last year, according to the US’s National Institutes of Health, compared with nearly 450 in Finland and 1,000 in Denmark.

These figures, while not definitive, represent a marked increase over the 120 trials that had an Irish component in 2013.

Medical professionals are seeking to capitalise on this in order to improve the country’s international standing in the area.

The impetus behind much of this growth has been the cancer research sector. Statistics commissioned by industry group Cancer Trials Ireland (CTI) show that 154 trials on various types of cancers involving nearly 7,000 participants were either at or beyond the recruitment stage in Ireland last year.

Cancer patients

A report compiled by DKM Consultants in May indicates that the Health Service Executive (HSE) saves about €6.5 million annually because some drugs it would normally have to pay for are used as controls against new medications tested on cancer patients in trials.

It is thought that CTI’s activities contribute €16.5 million to the State’s GDP overall each year.

Originally established as the All-Ireland Co-operative Oncology Research Group in 1996, CTI’s activities mean about 3 per cent of new cancer patients are offered access to the studies, which is in line with best international practice.

“We bring in free drugs, we create jobs, we bring in money from overseas,” says Prof Bryan Hennessy, a consultant medical oncologist at Beaumont Hospital who has had a long involvement with CTI.

“Many people with cancer still die from their disease, sometimes rapidly, so the treatments that we have are far, far off being perfect, and clinical trials are how they improve them.”

While his organisation has blazed a trail in bringing investment and studies here, its success has not been replicated for other major afflictions such as heart disease, stroke or diabetes, and Health Research Board (HRB) director of research Dr Maireád O’Driscoll can explain why.

“The bottom line is that the number of trials in Ireland has certainly increased over the last few years, but it’s still very, very low,” she says.

“The main reason is we’re just not really set up to support clinical trials at all. We just haven’t got a proper infrastructure and we haven’t got supports for clinical trials in Ireland. The one exception to that is cancer.”

Moves are afoot to address this trend, and industry commentators will be paying keen attention to the progress made by Clinical Research Co-ordination Ireland, a body established by the HRB that aims to attract trials for a wide spectrum of illnesses beyond cancers.

Ireland does benefit from a reasonably high number of specialist treatment centres staffed with skilled clinicians and researchers, but it often lacks the necessary co-ordination between health/academic systems and commercial entities that are willing to bring trials to the country.

Crucially, the austerity-hit public health system relies heavily on a small number of specialist clinicians who constantly devote themselves to frontline duties, meaning they are left with little time to perform research essential to clinical trials.

Concerns

Dublin-based clinical trials firm Icon can have up to 12,000 people recruited to its studies in any given year. Its chief medical officer Prof Brendan Buckley echoes many of the concerns voiced by the HRB.

“Ireland is not a bad environment; it has several really good things about it, there are pros and cons to everything,” he says, citing a rigorous regulatory regime and notable medical expertise across Irish hospitals.

“You have a hospital administration to get through, and clinical trials aren’t a huge priority for a lot of hospitals that are trying to do their core business.

“Some of the difficulty there is simply staffing. If you’re one of three or four cardiologists in a major university hospital in Ireland, you have a huge issue of just putting through the routine work,” adds Prof Buckley.”

A handful of high-profile breakthroughs in studies with an Irish element have highlighted the potential.

This includes the TAILORx trial. It involved the use of a breast cancer test- known as Oncotype DX- to differentiate between cancer sufferers who should be treated with toxic chemotherapy, and those who could survive with the aid of less harmful interventions.

“Ireland was one of highest accruers [an industry term for recruiters] to the trial. That in itself was excellent and gave us additional understanding of the test, utilising it and the benefits from it,” says St Vincent’s University Hospital consultant medical oncologist Dr Janice Walshe, who authored a subsequent review of the trial.*

“[Ireland] is seen very favourably by a number of the international clinical trial groups because they know we are very united in terms of putting people on clinical trials,” she says.

Stringent regulatory procedures enforced here by the Health Products Regulatory Authority (HPRA) have helped the country’s reputation, but our record is not unblemished.

There was some fallout from one particular test on a schizophrenia drug carried out in Cork’s Shandon Clinic, then Ireland’s only “contract” trial clinic.

It paid healthy participants to try experimental medicines, but three of the study’s 12 volunteers suffered seizures and were hospitalised.

A subsequent investigation report by the Irish Medicines Board, predecessor to the HPRA, revealed that inappropriate dosages of the active ingredient rimcazole hemifumarate caused the incident in 2010.

Although that particular business has since closed, it was undoubtedly an embarrassing episode for the wider industry.

Critical viewpoints

There are also those who harbour a distrust of “big pharma” and new medicine, and while CTI’s Prof Bryan Hennessy says he understands critical viewpoints, he believes it is imperative that they do not impede progress.

“I understand scepticism about pharmaceutical companies, but the reality is cancer treatment could not move forward without them,” he says.

“Without pharma companies we wouldn’t have 99 per cent of the treatments that we use, and we recognise that pharma is a business and that part of their goal is to make money, but they spend a huge amount of their resources [on] research, drug development and clinical trials.”

EU regulations due to come into force from 2018 will mean that member states must have a standardised process for approval of clinical trials.

Experts say some structural inefficiencies in approval regime continue to hold Ireland back, but as these are ironed out over the next 18 months as per EU rules, the domestic clinical trials environment may begin to flourish, according to Dr Maireád O’Driscoll.

“Have roadblocks been removed up to now? I suppose, no, they haven’t, but they’re going to have to be swept away ahead of that coming into place,” O’Driscoll says.

“There is definitely plenty of room for improvement, but we have recently started to put in place all the pieces that I think will improve it.”

*This article was edited on November 28th, 2016.