Clinical trial phases

Clinical trial phases

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 looking at how the body handles the drug, and side effects of different doses and to gain early evidence of effectiveness.
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 look at the effectiveness of the drug and its safety profile.
Phase III involves many more patients, typically several thousands, to continue to look at the effectiveness and safety of the medication. 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.

View our Current Studies

We're currently running a number of studies that relate to a wide range of conditions

View our studies

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