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Table 2 Description of the different phases of clinical trials

From: The use of mesenchymal stem cells for cartilage repair and regeneration: a systematic review

Clinical trial phases (http://www.nlm.nih.gov/services/ctphases.html)

 

Phase I: Safety Studies or First-In-Man. Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

 

Phase II: Uncontrolled Efficacy Studies. The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

 

Phase III: Randomised Clinical Trials. The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

 

Phase IV: Post-Market Surveillance. Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

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