There are four phases of Clinical Trials.
Phase 1
- First studies that involve humans
- Test how the drug should be given and if it is safe
- Small numbers of healthy volunteers or terminally ill people
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Duration – days to weeks
Phase 2
- Look at safety and efficacy
- Seek to find the best dose – maximum benefit and minimum side effects
- More people involved, usually 50 – 200
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Duration – months to years
Phase 3
- Confirm safety and efficacy
- Often comparison with 'standard of care' drug
- Larger numbers of people, 100 – 1000’s
- Duration – months to years
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Provide the data for government approval of drugs
Phase 4
- Long term safety monitoring and information gathering
- Post marketing approval
At SHOC CTU we concentrate on Phase 2, 3 and 4 clinical trials.
