Professor M. John Kennedy:

Patients who get clinical trials do well. They provide patients with an opportunity to receive advanced scientifically driven therapies before they are available, which might be critical for some people. The real hallmark of excellent cancer services is having plenty of clinical trials available for patients. We have enormous problems in this country with doing that. I will go through them from the beginning. We have a regulatory environment that is oppressive. We live in a small island in the north Atlantic off another small island and we are not at the races in terms of getting patients at clinical trials for a variety of reasons. The regulatory environment is hostile. It takes huge effort to get clinical trials up and running. If we cannot get them up and running in time, they close. If they are closed without having recruited to them, the people who sponsor those trials do not come back. That is the first problem we have.

The regulatory environment is under-resourced and under-professionalised, particularly in HSE-run hospitals. The data protection process is labyrinthine and contradictory. If multiple institutions are trying to collaborate on a clinical trial, multiple DPOs are giving multiple opinions requiring multiple amendments to studies. I could go on at length about this.

The clinicians trained in cancer in this country are trained in the finest institutions in the world where they have participated in, directed, written and published clinical trials of major importance. They cannot continue that work in this country to any significant extent, and to the extent that they want and that their patients deserve, because the environment is not suitable for doing that and they do not have the time to do it. One of the recommendations in the cancer strategy was that newly appointed clinicians in the cancer arena would have protected time to allow them to focus on doing this kind of work which requires a huge amount of effort; that has not happened.

We cannot recruit clinical trials staff because most of them are on temporary contracts and nobody wants a temporary contract nowadays; we cannot recruit people onto temporary contracts.

It is a matter of infrastructure and there are other outside issues as well. For instance, clinical trials nowadays are highly specialised to small numbers of patients with specific molecular abnormalities in their tumours. In the old days, when we did not know what the molecular abnormalities were we would have a mixum-gatherum where multiple patients would be eligible for trial. Now they are much smaller numbers.

There is huge work involved, inadequate resourcing and a regulatory environment that is basically hostile, leading to difficulty in inviting trials into the country and getting them up and running in a timely fashion. In a competitive commercial environment looking at new drugs, it is all about how fast we can produce the information that tells us this is a good drug or a bad drug and whether we can proceed with it.

We could have a whole meeting here about the difficulty of providing clinical trials to our patients. In my opinion it is a disgrace that we cannot get those trials available to patients in a timely fashion. Probably less than 2% of patients get on a clinical trial in this country. In a small country with a single health service and 5 million people, we should be easily able to get above 6% and up towards 10% but we have done so many things to make that impossible for us.

We have a huge pharma industry in this country. Those companies are probably equally frustrated that they cannot participate and collaborate with the health service effectively in making these drugs available for our patients.