Trial safety and regulations

Are clinical trials safe?

When a drug is being used in a clinical trial it has already been carefully tested to make sure it is safe to use in a clinical trial, though there may be serious side effects. The consent form you are asked to read and sign if you want to join the trial will explain expected side effects or problems. Your doctor will also discuss any risks with you.

The doctors and nurses who run the trial check throughout the trial that new treatments and their side effects are safe.

Your trial doctor and nurse will check you very closely throughout the trial. If the new treatment is not working as well as the standard medical treatment, you will be moved back on to the standard medical treatment.

Who approves clinical trials in Ireland?

Every clinical trial involving patients in Ireland must be approved by the Health Products Regulatory Authority (HPRA) and by a recognised ethics committee:

• The HPRA makes sure that the trial meets Irish, EU and international standards for clinical research.
• The ethics committee ensures that the rights and wellbeing of the patients who are taking part in the trial are looked after. For new medicines, the Department of Health supervises this process.
  
  
  
  If the trial application is approved by the HPRA and the ethics committee, the researchers can begin the trial. Once the trial has started it will be checked regularly to make sure the regulations are being followed and everything is being done correctly. 
  
  
  
  The HPRA can also make an official inspection of the trial at any time to make sure it is being carried out properly, with patient safety in mind.