Dr Rebecca Cramp
Director of Code and Regulatory Affairs, IPHA
A robust clinical research setup grants patients access to life-saving therapies. However, Ireland must improve its appeal for trials, as it lags behind European countries with similar populations and economies.
Ireland can play a leading role in the provision of clinical trials in Europe. To do that, a predictable, transparent and efficient clinical research system is essential to compete internationally and attract clinical trials. Healthcare providers in Irish hospitals and academic institutions have shown that they have the ability to participate and drive world-class research.
Clinical trial standardisation benefits
Ireland’s decision to join the European Clinical Research Infrastructure Network has the potential to widen access to clinical research networks in Europe. Aligned with this and to accelerate the conduct of clinical trials and increase delivery in Ireland, the Irish Pharmaceutical Healthcare Association (IPHA) developed a new standardised Clinical Trial Agreement between the Site and the Sponsor.
The Model Clinical Trial Agreement (mCTA) is an efficiency initiative, which can reduce delays in hospitals, cut costs, increase efficiencies and enable the faster start of more trials — all aimed at improving patient outcomes. Through the mCTA, we have movedtostandardise the approach to conducting clinical research.
This standardisation means speed in terms of the number of rounds of discussion and review for contracts being reduced. This, in turn, reduces the administrative and financial burden for hospitals and companies. Critically, it can reduce the time taken to start clinical trials in Ireland, thus improving trial competitiveness and, most importantly, improving individual patient health.
Alongside the positive human health
impact, clinical trials also enhance the
value proposition for innovation in Ireland.
Increasing clinical trial competitiveness in Europe
Alongside the positive human health impact, clinical trials also enhance the value proposition for innovation in Ireland, with potential to secure future global investment in manufacturing and discovery activity against significant competition. This drive towards competitiveness is not just of concern to Ireland, but across Europe.
According to a 2022 report published by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations, the US and China are gradually dominating clinical trials globally. In 2022, the US spent $2 billion more than Europe on R&D. Today, that figure is €25 billion.
With regard to clinical trial activity for advanced therapy medicinal products, it is twice as high in the US and almost three times as high in China than Europe. State and industry must work together, adopting best practices across the life science ecosystem to ensure a thriving R&D sector for the future of patients and medicines development in Ireland and Europe.