Caitriona Walsh
Country President and Managing Director of Novartis Ireland, Chair of Irish Pharmaceutical Healthcare Association (IPHA) Clinical Research Exchange Group
Including patients in clinical trials is critical in developing new, innovative treatments and improving the nation’s health.
Clinical trials and research can be good for the health and wealth of the nation. By participating in a clinical trial, patients may have access to innovative treatments and advanced medical care as well as contribute to medical advancement.
Furthermore, more research-active hospitals can have better healthcare outcomes overall — not only for those participating in the trials. Alongside this positive human health impact, clinical trials and research enhance the value proposition for innovation in Ireland.
How Ireland is advancing clinical trials
Both IPHA and the HSE are of the view that Ireland can play a leading role in the provision of clinical trials in Europe, and in recent times, significant steps have been made in this regard. One such step was Ireland’s decision to join the European Clinical Research Infrastructure Network, which has the potential to widen access to clinical research networks in Europe.
Last year, IPHA and the HSE agreed on a standard Contract Research Organisation (model) Clinical Trial Agreement (CRO mCTA) for use between the Site, the CRO and the Sponsor. The key to the success of the CRO-mCTA is that its standardisation will speed up the process by reducing the administrative and financial burden for the hospitals, CROs and companies. Also, in partnership with the HSE, IPHA launched the updated Bipartite Model Clinical Trial Agreement (CTA) for clinical trials, involving a commercial sponsor and a hospital(s), which supersedes all previous versions of the agreement.
Ireland can play a leading role in the
provision of clinical trials in Europe.
Government backing for clinical trials
From a political level, last July, the Minister for Health established the National Clinical Trial Oversight Group (NCTOG). This group aims to do better for patients by doubling the number of clinical trials taking place in Ireland, and it has already shown a tangible commitment to an improved era for health research.
This was followed by the inclusion in the Programme for Government of a commitment to increase the number of clinical trials and examine how better to support clinicians, researchers and support staff to focus on clinical trial activities.
These steps represent a win for all in the Irish healthcare ecosystem, but most significantly, they will increase the speed at which patients can access lifesaving interventions.
