The Clinical Trial Process

Clinical trials are a critical step in the process of finding new treatments and methods of medical care for women with ovarian cancer, turning scientific research into improved care for patients.

The goal of many clinical trials is to gain approval for the drug in use against ovarian cancer by the Food and Drug Administration.  This can be a lengthy process with three phases of research.

Phase 1:

Phase 1 trials evaluate the safety of a treatment. These studies typically enroll fewer than 50 people who have different types of cancer and determine the safe dosage and delivery method of a drug.  These trials also evaluate the side effects of the drug.

Phase 2:

Phase 2 trials test to see if the treatment works against ovarian cancer. These studies typically enroll about 100 women with ovarian cancer.

Phase 3:

Phase 3 trials test the new treatment against the best existing treatment, also called the “standard of care” or “standard care.” These studies typically enroll hundreds to thousands of women to determine if the treatment is safe and effective against ovarian cancer.  Phase III data is used to apply for FDA approval.

The National Cancer Institute’s guide, Understanding the Approval Process for New Cancer Treatments, offers in-depth information about the role of the FDA in this important process.

Learn more about Who Conducts Clinical Trials>