Clinical trials are the key to improving the prevention, diagnosis, and safe and effective cancer treatment. They are the process through which standards of care are defined. They are the pathways to develop and evaluate more effective and less toxic therapies.
New treatments are tested in a series of trials known as Phase I, Phase II and Phase III trials. New cancer therapeutic agents are evaluated and approved by the US Federal Drug Administration (FDA) only after the Phase III clinical trials have demonstrated evidence of superior outcomes or less toxicity when compared to standard treatments. Similarly, new surgical approaches are uniformly recommended and adopted after Phase III trials demonstrate superior safety, tolerability and/or effectiveness.
Drug studies can begin in patients only after the FDA and a local institutional review boards (IRB) have given approval. The IRB is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research. One of the responsibilities of the board is to ensure that clinical trial participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm.
Prior to a drug even entering Phase I trials, it is well studied to learn about how best to prepare, store and administer the drug. Preclinical testing is usually conducted in animals and human cell cultures.
Learn more about clinical trials by following these links:
- Importance of Clinical Trials Participation
- Frequently Asked Questions about Clinical Trials
- Clinical Trials Phases
- Questions to Ask Your Doctor or Research Office Nurse
- Foundation for Women’s Cancer Research Program
- Clinical Trials Brochure
Importance of Clinical Trials Participation
Only about 5% of women with a gynecologic cancer participate in the dozens of gynecologic cancer clinical trials. The predominant hope for improving on the treatment options for women diagnosed with a gynecologic cancer is through the conduct of clinical trials.