Regulation for Innovation - IPHA

Regulation for Innovation

Process reforms can help to make Ireland a European leader in clinical trials, writes Dr Rebecca Cramp

Clinical trials are used to evaluate the safety and effectiveness of a medicine or a vaccine. A strong clinical research infrastructure gives patients access to sometimes life-saving treatments. But Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances. We believe that should change.

 

Our recent Clinical Trials Performance Survey, capturing data from 2013 to 2021, shows that IPHA member companies sponsored or collaborated in 294 out of 422 listed industry-sponsored interventional clinical trials. Most of these clinical trials, or 74%, were in Phase III. Cancer accounted for just over half of all IPHA member-sponsored clinical trials.

 

Ireland attracted fewer industry-sponsored clinical trials in the period than Finland and Denmark. Of 2,290 clinical trials carried out in the three countries, 18% were conducted in Ireland compared to 29% in Finland and 53% in Denmark.

 

Fewer clinical trials were conducted in all three countries in 2019 and 2020 due to Covid-19.

 

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 Model Clinical Trial Agreement, 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 should cut the time needed to start clinical trials, making us more competitive in attracting trials. But 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 do all this, we can make progress for patients and help Ireland’s international reputation as a place to conduct research.

 

Dr Rebecca Cramp is Director of Code and Regulatory Affairs at the Irish Pharmaceutical Healthcare Association.