Types of Clinical Trials
A woman is eligible to participate in a clinical trial at any point in her experience with ovarian cancer. Many women think of clinical trials as an option only after other treatments have failed. Clinical trials exist for women in this situation, but many equally important trials are available for women earlier in their fight against ovarian cancer.
Prevention trials test ways to reduce the risk of ovarian cancer. They typically enroll healthy women at high risk for developing ovarian cancer or survivors who want to prevent its return or reduce the chance of developing a new type of cancer.
Screening trials look for ways to detect ovarian cancer at an early stage in healthy women.
Diagnostic trials seek to develop better ways to diagnose and care for women with ovarian cancer. They usually enroll women who have already had ovarian cancer or who have signs and symptoms of it. Many of the current diagnostic trials in ovarian cancer focus on proteomics, which involves evaluating the levels of different proteins in the blood.
Treatment trials determine what new treatments or combinations of existing treatments can help women who have ovarian cancer. They evaluate the effectiveness of new treatments or new ways to use existing treatments. (A “treatment” may be a drug, therapy vaccine, surgery or any combination of these.) Various treatment trials exist for women with ovarian cancer, most of which explore the effectiveness of different combinations of surgery and drug therapies in fighting ovarian cancer.
Quality-of-Life/Supportive Care Trials
Quality-of-life/supportive care trials aim to improve the quality of life for ovarian cancer patients, survivors, and their families. These may include issues like side effects from chemotherapy like neuropathy or nausea or need for pain medication.
Usually part of another clinical trial, genetic trials attempt to determine how a woman’s genetic makeup can influence the detection, diagnosis, prognosis and treatment of ovarian cancer. (Family-based genetic research studies exist that differ from cancer clinical trials; in these studies, multiple high-risk family members may give blood and tissue and agree to be evaluated on an annual basis.)
Phases of Trials
Clinical trials occur in sequential phases, each of which serve a different function. Here is how the National Cancer Institute describes the trial phases:
- In Phase I trials researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.