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Typically, any clinical trial will go through a series of phases. These phases include the following:
Phase I
- Clinical pharmacological studies
- First time in human (usually non-patient volunteers)
- Kery pharmacokinetic data
- Safety / tolerability data
- Usually defines dose for Phase II studies
- Small number of participants - usually health volunteers
- Duration - several days to several weeks
Phase II
- Investigates safety and efficacy (effectiveness)
- Dose tolerability
- Dose ranging with multiple doses
- Seeking maximum benefit with minimal side effects
- Greater number of participants (50 - 200)
- Duration - months to years
Phase III
- Confirm safety and efficacy
- 100-2,500 participants
- Duration - months to years
- Data from these studies provide the basis for government approval for market availability
Phase IV
- Long term safety monitoring
- Post-marketing approval
- Better definition of toxicities
- Cost versus benefit analysis
At the HOCA Research Centre we specialise primarily in Phase II and Phase III trials. To find out how you can take part in a clinical trial click here.
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