Regulation for Innovation

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 discussion and review for contracts should be reduced. That, in turn, should reduce the administrative and financial burden for hospitals and companies. It will cut the time needed to start clinical trials, making us more competitive in attracting trials. However these measures, on their own, won’t be enough.

We have urged reforms in the clinical trials process to help accelerate new medicines development and raise standards of care. These steps should help.

1. Standardise clinical trial start-up requirements (including Data Protection Impact Assessments) and timelines for hospitals; 
2. Designate specific clinical trial signatories in each hospital with a standard sign-off process;
3. Appoint one permanent clinical research nurse post for each teaching hospital;
4. Ring-fence clinical trial funding and working time for multidisciplinary research; and,
5. 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.