Clinical Trials in Ireland
All medicines must under go clinical trials before they are granted a license in Ireland, or in Europe. However, before a license can be granted, a medicine must go through several stages of clinical trials - known as phases, and these will either involve healthy volunteers or ill patients.
Generally, IPHA member companies conduct Phase II, III and IV clinical trials in Ireland. As part of the initiative for greater transparency and better access to clinical trial information, companies register ongoing clinical trials and results of completed clinical trials on the IFPMA Clinical Trial Portal and for many of the larger companies with larger websites, also on their company websites. The information provided on each trial is that agreed with the WHO.
The aim of the clinical trial is to evaluate the safety and the effectiveness of the medicine. It is also used to discover what side effects the new medicine has, and whether it positively benefits the health of ill patients. The data from these clinical trials is then reviewed by the Health Products Regulatory Authority (HPRA) or other regulatory agency to determine if the benefits of the medicine outweigh the risks. This is called the benefit/risk assessment.
Before authorisation to conduct a clinical trial is granted in Ireland an application with supporting medical and scientific data must be submtted to the IMB for medical and pharmaceutical review. The supporting data partly consists of laboratory and animal testing and tests for toxicity. This data is then reviewed by the HPRA to determine whether the drug is scientifically valid and properly researched at the pre-clinical trial stage. They must also obtain a positive opinion from an Ethics Committee, which is independent of the pharmaceutical industry established and supervised by the Department of Health. These Ethics Committees are at liberty to reject a clincal trial on ethical grounds.
Once authorisation has been recevied from the HPRA and the Ethics Committee, a clinical trial can then be carried out by the pharmaceutical company or commissioned to medical / academic institutions, as well specialist clinical research companies.
The clinical trial must also be conducted in accordance with Good Clinical Practice (GCP). Clinical trials are regularly audited by the IMB to ensure compliance. According to the Regulation (EU) no. 536/2014, article 2, clause 2(30):
Good clinical practice means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the trial is reliable and robust.
- HSE Clinical Trial Indemnity Form (HSE CTIF)