The WHO defines and describes Clinical Trials in the following way:
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.
Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.
There are 4 phases of biomedical clinical trials:
- Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
- Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
- Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved.
- Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.
HSE & Clinical Trials
The term ‘clinical trial’ in the HSE National Framework for the Governance, Management, and Support of Health Research (RGMS Framework) includes regulated and non-regulated trials as well as clinical investigations of medical devices. The details of how the HSE deals with Clinical Trials within the organisation is outlined here.
HPRA (Health Products Regulatory Authority)
The Health Products Regulatory Authority (HPRA) regulates medicines and devices for the benefit of people and animals. Its remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.