When new drugs are developed, the first tests are called pre-clinical studies. If results are promising, the next step is a clinical trial. Clinical trials aim to find out whether the treatment is safe and effective for humans to use or consume. Trials consist of four phases, and they can focus on treatment, prevention, diagnostic, screening, supportive care, health services research, and basic science. Clinical trials help the research team answer specific questions before the drug (or device) can be sold to the public.
Test an experimental drug on a small group of people for the first time. Assess the drug’s safety and find out what a safe range would be for dosage, and identify side effects.
The drug is given to a larger group of people (usually 100 or more) to test effectiveness for a particular disease or condition. Further assessment of safety and dosage.
The drug is given to even larger groups of people (usually 1,000 or more) to confirm its effectiveness, monitor side effects, and comparison to other commonly used treatments.
These trials are done after the drug is approved and is on the market. They gather information on things like the best way to use a drug, and the long-term benefits and risks.
The people who carry out clinical trials are called investigators and Canadian law requires that investigators are physicians. Trials follow strict scientific standards, Health Canada guidelines, and occur in the final stages of a long and systematic research process.