Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.
- Phase 1: Screening for safety
- Phase 2: Establishing the testing protocol
- Phase 3: Final testing
- Phase IV: ‘Post-approval’ studies
In Phase 2 trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.