Childhood cancer remains a leading cause of death in children and when patients have their cancer return is when they need the most advanced care. At Levine Children's Hospital, we continue to strive to offer our families different options for cure which can be delivered in our community. With increased number of clinical trials comes great responsibility to the Charlotte region to offer them safely and effectively.
Phase I Clinical Trials:
Phase I studies utilize a small group of patients to test variables of treatment, safe dosage, method of administration, bodily interaction and the identification of possible side effects.
Phase II Clinical Trials
Phase II studies utilize a slightly larger group of patients to measure the effect a specific treatment has on a certain cancer. Phase II studies continue to monitor short-term side effects and begin to develop dosing/treatment schedule and amount and typically involves 2 groups of patients with one group as a control.
Phase III Clinical Trials
Phase III studies involve larger groups of patients (over 100) and compare effectiveness of the new intervention with the current standard of care/treatment. These trials also continue to examine side effects of the new treatment and compare with the usual treatment. In Phase III trials there is a possibility that the new intervention/treatment is found to be more effective than the current standard of care/treatment; therefore, the new intervention may become the new standard of care/treatment.
Phase IV Clinical Trials
Phase IV studies involve very large groups of patients (several 100 to thousands) and they are run to further evaluate the safety of interventions/treatment, both long term and short term. These studies usually occur after the Federal Drug Association (FDA) has approved the intervention for standard use.
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