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Phases of Clinical Trials 

Clinical TrialsBefore any medicine is made available to the public, it must undergo a clinical trial. Clinical research consists of four phases: 

Phase I 

Phase I trials evaluate how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often the drug should be given, and amounts for a safe dosage. A Phase I trial usually enrolls only a small number of patients. 

Phase II 

Phase II trials continue to test the safety of the drug, and begin to evaluate how well the new drug works, generally on a particular kind of cancer. In a Phase II trial, the study drug or treatment is given to larger groups of people (100-300). 

Phase III 

Phase III clinical trials compare the results of people taking the new drug with the results of people taking standard treatment. In a Phase III trial, the study drug is given to large groups of people (1,000-3,000) 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. The time frame for this phase usually is several years. 

Phase IV 

Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about its side effects in various populations and any side effects associated with long-term use. 


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If you have any other questions or concerns, please contact us as we will help guide you in the right direction.

For additional information about clinical trials available through Scottsdale Healthcare Research Institute, contact the Cancer Clinical Trials Coordinator at 480-323-1339 (toll free: 1-877-273-3713), or e-mail clinicaltrials@shc.org.