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When Clinical Lead of Cancer Trials Ireland Prof Bryan Hennessy worked at MD Anderson Cancer Centre in Texas, US, he recalls how some patients travelled across the country — and from outside the US — to access clinical trials.
Yet in Ireland, clinicians sometimes have reservations about the idea of referring patients to hospitals in other parts of this country, not least because of the lengthy travel for patients, according to Prof Hennessy. But it is vital to discuss options with patients, he added.
“I feel — and a lot of us feel — it is important to give patients the choice, to let them make the decision as to whether travelling to a different hospital is too much of a burden for them or if it is something they would like to pursue and look at, because clinical trials are important and they give us continual access to new therapeutics and early drugs that are promising in terms of investigation in cancer,” outlined Prof Hennessy, Consultant Oncologist, Beaumont Hospital, Dublin.
It is not feasible for all trials to be accessible at each of the 14 hospital-based oncology research units, he explained.
“Just like you can’t have access to breast cancer surgery in every hospital in the country, there are disadvantages to putting things in every hospital that are now recognised as outweighing the advantages of doing that and we have seen that at multiple levels, including, as I said, with breast cancer surgery,” outlined Prof Hennessy.
“I think it is a fact of running these trials — and subspecialisation and other factors — that sometimes they can only be placed in some units around the country and I think it is important to discuss that with patients and give them the option.” Internationally, it is recognised that access to trials should be a routine part of patient care, not least because many cancers cannot yet be cured, he said.
Prof Hennessy wrote on cross-hospital referral in his editorial in DSSG Digest, spring 2017. He noted that some patients attending hospitals where his own PantHER study was not open had been referred by their consultant to his team at Beaumont.
He urged colleagues to review studies and trials listed in DSSG Digest (and available at www.cancertrials.ie) and talk to the Principal Investigator about referring potentially eligible patients to a hospital where it is available.
“The feedback I got from that piece [editorial] was uniformly positive. And I think people do see the importance of discussing this option with patients and to have an open discussion with them about the availability of trials when they are elsewhere, and the pros and cons of being referred for them.”
Cancer Trials Ireland has also been encouraging patients to ask their oncologist about trials available that are not necessarily operating in their hospital.
The organisation has a target of 5 per cent of cancer patients involved in cancer drugs trials. The figure is currently around 3 per cent. Cancer Trials Ireland is hoping a target will be set in the new national cancer strategy.
Prof Hennessy commented: “We know that the cancer strategy, for the first time, will reflect research specifically, and will hopefully put it on the HSE’s radar in terms of an important component in service development moving forward. And we are hoping that that specific target, or a specific target goes in, that will encourage all parties, including the HSE, to promote and help us advance research.”
The question of funding and resourcing is a perennial one for Cancer Trials Ireland. Its main funding comes from the Health Research Board (HRB). In the years 2013 to 2015, this grant totalled €3,748,000 per year (€3,024,713 per year was distributed to research units and €723,287 used for Cancer Trials Ireland’s central clinical, research and data management staff costs). For the period 2016 to 2018, the HRB grant dropped to €2,998,400 per year (€2,419,767 per year is distributed to research units and €578,633 used for central clinical, research and data management staff costs).
CEO of Cancer Trials Ireland Ms Eibhlin Mulroe said more support is required to sustain and grow Ireland’s capability to conduct clinical trials.
“[The grant] provides the core support to our sites… to conduct a trial you need to have a core team… you need to have a clinical research nurse, you need to have a data manager and you need to have clinicians with time to do research and one of the things we’d like to be able to do is facilitate that infrastructure and… give a higher base core funding to each of the sites, so that they could at least have [the required funding for staff]. Because if you don’t have people at a site to work on trials, then it is very difficult to organise them.
“I am just back from London and met with people from the NIHR [National Institute for Health Research] and the NHS, where clinical research is an integral part of what they do. It is part of their budget line items and they fund clinical research infrastructure, they fund people that work in it, and I think we are going to have to get to that point.”
Cancer Trials Ireland also receives funding from the Irish Cancer Society and it obtains support from collaborative groups with which it runs studies, such as the Eastern Co-operative Oncology Group (ECOG) and Translational Research in Oncology (TRIO).
“They are not-for-profit but they are running investigator-led studies with industry funding, so we do a lot of that and over half of our income is coming from that [approach], rather than from the State. That is not going against the grain; that would be pretty normal, but we would like to see more infrastructure development in our hospitals and more support around that.”
Service pressures are significantly impacting on the time consultants in Ireland can devote to oncology research and clinical trials.
“I mean, very few consultants have specific time set aside for research,” said Prof Hennessy. “I would say, and I think others would say too, that we are a shining light in terms of an example of how clinical research should evolve for a medical specialty and I think all of that has evolved because of people who have gone above and beyond and put in massive effort, despite having no protected time or resources to do that. And now we are at a place where we can advance ourselves further if we start to look at this issue and recognise that we have come as far as I think we can go without having oncologists with dedicated time for research. We can’t grow any further if we don’t encourage that, and so we ourselves have looked at helping in that regard. But we can’t take a lead there — I think that needs to come from the NCCP [National Cancer Control Programme] and the HSE, in terms of providing protected time and resources to help people to develop research further and hopefully the new national cancer strategy will assist us in that regard.”
Many Irish-trained doctors who complete higher specialist training in fields such as oncology go abroad to undertake fellowships. Ireland has traditionally relied on ‘the call of home’ to get these specialists back, but now this is often not enough, said Prof Hennessy.
While the reasons for this are “multiple”, having a good research capability embedded in clinical practice would be a “major factor in encouraging these people to come home”, he said.
In Ireland, clinical research often “plays second-fiddle” in the face of health service constraints. “The units in hospitals around the country, they require research nurses, data managers, a unit manager, pharmacy… the core grant from the HRB and the Irish Cancer Society isn’t enough to fund everything that a trials unit in each of the hospitals requires to be fully functional and successful. The units have to rely on philanthropy and goodwill, as well as the grant we get, and that is an everyday struggle,” said Prof Hennessy.
Ms Mulroe said there are serious regulatory obligations when running a clinical trial and resourcing is vital in this respect. “As a result, we ask hard questions here about studies we can and cannot do … even if the research question is very good, we have to ask, ‘can we afford to do that and meet all of our obligations?’ That is very hard… at the moment we can only reach a certain level of activity and we can’t go beyond that without more investment.”
Resourcing issues have affected the opening of new studies at some hospitals.
Prof Hennessy said: “Imagine having studies put on the back-burner for months because of an issue like that and they can’t open new studies. It is frustrating for all levels, most importantly for patients who can’t get access to new studies, new treatments for several months, because of staffing issues… ”
He added that, in these circumstances, ongoing studies are prioritised. “The priority has to be to patients who are currently on study to ensure they continue on the study and are safely continuing… that is where resources go when there is an issue like that.”
Currently, there are over 6,000 patients involved in more than 150 trials under the auspices of Cancer Trials Ireland.
Prof Hennessy remarked: “We have always provided access to new drugs and promising drugs, but we are looking at developing our very early-phase research capability to provide patients with access to new drugs from the moment they are entering clinical trials… we are developing our expertise in that area and hoping that will provide even more access — earlier access and even longer access — to new and potentially promising drugs for patients.”
The Health Products Regulatory Authority (HPRA) is “very happy for us to run phase 1 trials; they have inspected us a huge amount”, he noted.
Ms Mulroe added: “We sponsor studies and when you sponsor studies you are open to inspection, to the rigor of the HPRA, and we have been through that and come out the other end. It is one of the reasons why it is important to have a Clinical Lead and Vice Clinical Lead who can be involved in our medical oversight processes here… there are 51 people in the building and they are all involved in monitoring, pharmacovigilance, quality, and for a small not-for-profit in Ireland, that is pretty good.”
On the issues of high drug prices and ending of compassionate access schemes, Cancer Trials Ireland does not see itself in an advocate role, they explain. It is also pointed out that an independent report commissioned by the organisation last year conservatively estimated that drugs savings to the HSE directly from cancer trial activity is in the region of €6.5 million annually.
Meanwhile, Cancer Trials Ireland is also seeking to attract more involvement from translational researchers. “We have every oncologist and radiation oncologist in some way involved in our organisation,” said Ms Mulroe. “We have translational researchers involved but we want them all, so that we can start discussions on what we can do in terms of bringing the ideas from the lab into the clinic… there are a lot of translational researchers and we have met some of them out there who have ideas and they want to work out how they can make that transition.”