Dr Itziar Canamasas, Managing Director, Bayer Ltd and Chair of the Irish Pharmaceutical Healthcare Association’s (IPHA’s) Clinical Research Exchange Group
Clinical trials give patients access to sometimes life-saving trials; they help set the standard of care for patients and they are also vital for boosting innovation; just three of the many reasons why a country should constantly strive to improve their clinical trial infrastructure. Ireland is in a unique position to draw on our strong base of international pharmaceutical companies and highly regarded healthcare professionals who are experts in managing clinical trials together with a supportive public policy environment.
All of the key stakeholders including industry, must actively collaborate together to realise our shared ambition to make Ireland a leading location for clinical trials.
In light of this, where do we stand today in terms of our clinical trials infrastructure? IPHA recently conducted a survey among member companies to gain an understanding of recent performance in terms of start-up speed and ability to deliver recruitment targets. Not only did this survey give some insights into recent performance but it also quantifies a baseline to set and measure future targets against.
The results of the IPHA survey show that, on average, it takes about eight months to recruit the first patient into a clinical trial in Ireland. That figure is based on 90 trials set up between 2013 and 2018 across 11 therapy areas and all four phases of the clinical development process. The measure is the number of calendar days it takes to recruit a first patient into a trial from the date the company submits to a Recognised Ethics Committee – the international best practice structure for overseeing the conduct of ethical standards in healthcare research.
Looking to Denmark, a country of similar size, it had approximately three times the number of registered studies at the end of 2018 compared with Ireland. Notwithstanding these higher numbers, it currently takes six months to recruit a patient into clinical trials in Denmark, which is 25 per cent shorter than in Ireland.
The delay experienced in Ireland has potentially far-reaching consequences, most importantly for patients who are missing out on opportunities to access what could be life-saving medication and contribute toward the development of improved detection techniques and diagnosis.
There is no reason why Ireland can’t emulate Denmark’s success. Implementing some of the following changes would help make strides to reduce the time it takes to recruit the first patient into a clinical trial in Ireland:
• The standardisation of site contracts (the Clinical Trial Agreement) that is standard in a number of other EU countries. This will shorten delays and save on legal fees for both hospitals and companies;
• Be consistent in our approach to clinical research across all institutions;
• Provide realistic targets for clinical trials that are achievable and can be relied upon. This means meeting a lower target is better than partially meeting a higher target.
While the survey has helped identify where improvements can be made to benefit patients in Ireland, it is equally important to recognise some of the great work which is already ongoing to improve the clinical trial infrastructure in Ireland: for example, the impending implementation of the Clinical Trial Regulation; new ways of identifying and recruiting patients; and the investment in clinical research over the past decade. The HRB-CRCI feasibility service has processed 255 studies over the past four years. Most of these are pharmaceutical industry trials. Progress is being made in therapy areas including oncology, haematology, cardiology and respiratory and infectious diseases.
Ireland’s recent decision to join the European Clinical Research Infrastructure Network (ECRIN) has the potential to give us access to large populations of patients and collaborations across countries. It is also hoped that Ireland’s membership of ECRIN will help us to take on the country sponsor role for more pan-European clinical trials and ultimately benefit Irish patients.
As well as the positive human health impact, clinical trials enhance the value proposition for innovation on which Ireland needs to keep working to secure future global investment in manufacturing and discovery activity against significant competition. It is important for all key stakeholders to actively collaborate to realise a shared ambition of making Ireland a leading location for clinical trials.