Types of clinical trials
There are four main types of clinical trials:
- Phase 1:
- The aim of these trials is to find out the best dose and whether the new treatment is safe.
- Phase 2:
- These trials give more information about how safe the treatment is and whether it works or not.
- Phase 3:
- If a Phase 2 trial suggests that the treatment is safe and works, then the treatment is tested in a Phase 3 trial.
- The aim of Phase 3 trials is typically to find out whether the new treatment is better, worse, or just as good as a different treatment option.
- These trials also provide more information about the safety of the treatment.
- Phase 4:
- These trials are done after the government approves the treatment for use.
- In Australia, the “gatekeeper” organisation is the Therapeutic Goods Administration (TGA).
- Phase 4 trials continue to look at the safety of the new treatment and how well it works.
What this means is...
There are different stages of clinical trials and each stage has a different aim.
------------
Content on this page was generated via the GenE Compass project. The following article provides more information about the project:
- Robertson EG, Kelada L, Best S, Goranitis, I, Grainger N, Le Marne F, Pierce K, Nevin, SM, Macintosh R, Beavis E, Sachdev R, Bye A, Palmer EE. (2022). Acceptability and feasibility of an online information linker service for caregivers who have a child with genetic epilepsy: a mixed-method pilot study protocol. BMJ Open, 12:e063249. https://doi.org/10.1136/bmjopen-2022-063249