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Sponsored by Synexus, a recruiter for clinical trials
Sponsored by Synexus,
a recruiter for clinical trials
Once the relevant scientific, regulatory and ethical bodies have approved the protocol, clinical studies in humans can go ahead. There are four phases of this process:
Phase I has the objective of ensuring the treatment is safe. The treatment is tested in small doses on a small pool of people, usually healthy volunteers, to check for any side effects.
Phase II tests the treatment in a larger number of people. This group of people have the condition for which the treatment is designed. The purpose of Phase II is to ensure that the treatment is safe, and that it is effective.
Phase III involves many more patients, typically several thousands. Treatments only move on to Phase III once the objectives of Phase I and II have been achieved.
During Phase III studies, the treatment under investigation is tested against a treatment currently in use or a placebo to see how well it compares. The study participants will be unaware which treatment they are taking.
These three stages of testing can take between 10 and 12 years. Only at this point will the treatment be considered for licensing by the relevant authority.
Following licensing some treatments undergo Phase IV testing. This phase is designed to find out more about the long-term risks, benefits and use of the product in different populations, such as children.
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