Phase I – Studies the effects of a new drug on human subjects
Phase I studies are designed to establish the effects of a new drug in humans. These studies usually are conducted on small populations to determine specifically a drug's safety, dosage, and side effects.
Phase II – Studies the effects of a new drug on a specific patient population
After the successful completion of Phase I, a drug is then tested for safety and effectiveness on a larger population of individuals who have the disease for which the drug was developed. |
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Phase III – New drug tested against established drugs currently used in treatment of the disease in question
The third and last ‘pre-approval’ round of testing is conducted on large populations of patients. Phase III studies usually test the new drug in comparison with standard therapy currently being used for the disease being studied. The results of these trials usually provide the information that is included in the package insert and labeling.
Phase IV – Compare the drug to its competitors and further study any adverse effects
This phase takes place after the FDA has approved a drug. Phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any side effects. |
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| One of the hallmarks of Tower Cancer Research Foundation, resulting in a very high level of accuracy in the clinical trials, is the personal attention patients receive at our facility. Tower physicians stay with patients every step of the way. Physicians and research nurses closely monitor each patient throughout the trial, tracking effects, side effects and the details of |
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treatment.The fact that the doctors take this hands-on approach makes them the driving force behind the entire process. It is this type of personal care and attention to accuracy that produces optimum results for the trials, the patients and the pharmaceutical companies that are sponsoring new trial drugs or treatments. |
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