Process reforms can help to make Ireland a European leader in clinical trials, writes Dr Rebecca Cramp
Page last updated on 27 November 2024
Clinical trials are used to evaluate the safety and effectiveness of a medicine (including vaccines). A strong clinical research infrastructure gives patients access to sometimes life-saving treatments. However, Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances. We believe that this should change.
See our recent Activity Comparison Report.
Ireland should attract more clinical trials, especially with the scale of the biopharmaceutical industry’s manufacturing footprint. We should aim to be a leader in clinical trials in Europe.
Through the bipartite Model Clinical Trial Agreement, and tripartite model Clinical Trial Agreement (CTA) we have moved to standardise the approach to conducting clinical research.
Standardisation means speed – the number of rounds of contract discussion and contract review is reduced as a result of standardisation. That, in turn, reduces the administrative and financial burden for hospitals and companies. It cuts the time needed to start clinical trials, making us more internationally competitive in attracting trials. However, these measures, on their own, won’t be enough.
We urge the Government to introduce reforms in the national clinical trial regulatory application process to help stop unnecessary delays, accelerate new medicines development and raise standards of care for patients. The following steps should be taken by the Government.
- Standardise clinical trial start-up requirements (including Data Protection Impact Assessments) and application review timelines for hospitals;
- Designate specific clinical trial signatories in each hospital with a standard sign-off process and timelines;
- Appoint one permanent clinical research nurse post for each teaching hospital;
- Ring-fence clinical trial funding and working time for multidisciplinary research; and,
- Protect dedicated research time.
If we achieve this, we can make progress for patients and improve Ireland’s international reputation as a place to conduct clinical research.
Dr Rebecca Cramp is the Director of Code and Regulatory Affairs at the Irish Pharmaceutical Healthcare Association.