Before a drug is used in a clinical trial, it undergoes thorough testing to ensure it is safe for use. However, there may still be a risk of unexpected or serious side effects. If you decie to participate in a trial, you will be given a consent form that explains the possible side effects. Your doctor will also discuss any other risks with you. Your trial doctor and nurse will closely monitor your progress throughout the trial. If the new treatment is not as effective as the standard medical treatment, you will be switched back to the standard treatment. In Ireland, every clinical trial must receive approval from a recognised ethics committee and the Health Products Regulatory Authority (HPRA), which has the authority to conduct inspects of a trial at any time to ensure it is being carried out correctly and with patient safety in mind.
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