- Gynecologic Cancer Clinical Trials: What This Means for You: This is a video teaching tool for patients who might be interested in participating in a gynecologic cancer clinical trial. This video is made possible by a generous grant from the GOG Foundation, Inc.
- Understanding Gynecologic Cancer Clinical Trials Video
- Clinical Trials: Your Guide
- Clinical Trials Glossary
- Clinical Trials Glossary (PDF)
- Frequently Asked Questions about Clinical Trials
- Questions to Ask Your Doctor or Research Office Nurse
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.
Importance of Clinical Trials Participation
Only about 5% of women with a gynecologic cancer participate in the dozens of clinical trials in gynecologic cancers. The predominant hope for improving on the treatment options for women diagnosed with a gynecologic cancer is through the conduct of clinical trials.
The Foundation for Women’s Cancer actively works with the Gynecologic Oncology Group (GOG) to encourage women to participate in clinical trials. Clinical trials are a crucial step in finding new and improved ways to improve treatment for women diagnosed with a gynecologic cancer.
Three examples of the important advances in the care of women as a result of clinical trials include:
- Chemotherapy added to radiation improve cure rate in locally advanced cervical cancer (GOG 120, 109)
- Platinum based chemotherapy plus paclitaxel is superior to platinum based chemotherapy plus cyclophosphamide (GOG 111)
- IP therapy improves survival in subsets of women with newly diagnosed advanced ovarian cancer (GOG 172)
The patients that participated in the phase III clinical trials that led to these discoveries were among the first to benefit from these scientific advancements.