What are clinical trials?

New treatments must be proven safe and effective with a certain number of patients before they can be made widely available.

Clinical trials are studies involving patients and are one stage of a long and careful research process. Getting promising results from laboratory testing on a new drug is a preliminary step to clinical trials.

Each trial is designed to show how a particular anticancer strategy attacks the cancer, affects people who receive it, and improves survival rates. Participants receive high-quality cancer care and will be among the first to benefit if a new approach is successful. Through informed consent, patients learn about a study's treatments and tests, and possible benefits and risks, before deciding to participate.

Every study has its own guidelines for who can participate. Generally, participants are alike in key ways, such as the type and stage of cancer, age, or gender. In trials involving cancer patients, placebos are rarely used, and many trials compare a new treatment with a standard one. In these studies, patients are randomly assigned to one of two groups.

Health plans and managed care providers don't always cover all patient care costs in a study. Ask a doctor, nurse, or social worker from the study to help you determine in advance what costs are covered. The study sponsor covers the research costs, such as data management, and often, the specific new drug being evaluated.

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