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Clinical trials are an important part of the continuing battle to fight cancer. They involve the evaluation of new treatment methods with the help of human volunteers. Before a new drug clincial trial is performed, it has been evaluated extensively in lab and animal studies, and requires approval for testing by the FDA.

Phase 1 studies are the first introduction of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients or normal volunteer subjects. Presbyterian Cancer Center does not participate in Phase 1 studies.

Phase 2 studies are conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the type of cancer under study. The goal of Phase 2 studies is to determine the common short-term side effects and risks (if any) associated with a new drug.

Phase 3 studies are performed after there is preliminary evidence suggesting that a new drug is effective for cancer treatment. In a Phase 3 study, researchers gather the additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. In addition, information from a Phase 3 study is used to provide guidelines for physician labeling.

After a drug has been approved for marketing by the FDA, Phase 4 studies gather additional information about the drug's risks, benefits, and optimal use.

For more information about ongoing cancer research studies at Presbyterian, call 704-384-5369 and ask for assistance from a cancer research nurse.