Clinical trials are conducted to gather information on the safety and effectiveness of a new drug, medical device or other treatment. They can only take place under licence from a health authority or ethics committee. They can include:
- randomised control trials, where a control group of patients who do not receive the treatment under test are compared with a group of patients who do receive the treatment under test; and
- observational trials, where information is collected on a new treatment and compared to results from patients who have received an existing alternative treatment.
Information must also have been gathered on the product’s quality and feasibility before a clinical trial can commence.
