Clinical trials are biomedical research studies performed in people that follow a predefined set of procedures to test the safety and effectiveness of new diagnostic tests, treatments and methods to prevent diseases. In cancer research, a clinical trial assesses new ways to diagnose, treat, screen and prevent cancer. Clinical trials can be sponsored by pharmaceutical companies, federal agencies, medical institutions, foundations, voluntary organizations and physicians. They can occur in hospitals, universities, doctors’ offices, or community clinics. The clinical trials team includes physicians, nurses, social worker and other health care professionals, who will assess your health at the trial’s beginning, provide instructions and monitor your health during the trial, and maintain contact with you when the trial is completed. Many medical advances we have today, including all the drugs that are currently used to treat ovarian cancer patients, came about as a result of clinical trials.
Clinical trials are important to assess whether a new diagnostic method can predict a disease, that a new treatment is safe and works in people, and that a preventive agent can thwart a disease. The testing of a new drug for cancer often starts in animal models of a disease or in cells grown in petri dishes or test tubes. Drugs that show some success in the animal models or cell culture become candidates for clinical trials. What works in the laboratory animals and cells may prove to be very effective in people or may not work in the human body and reveal side effects.Many treatments available for cancer today underwent clinical trials. Researchers must apply to the Food and Drug Administration to test new drugs and get approval from the agency before a clinical trial can begin. The FDA also has to approve results from a clinical trial before a drug can be marketed for specific diseases.
Clinical Trials and Ovarian Cancer
Ovarian cancer treatment during the past 40 years has improved because of clinical trials. The big breakthrough for ovarian cancer came in the 1970s with the use of cisplatin as a chemotherapy after clinical trials showed it effectiveness. Other drugs used at that time extended life for a little more than a year, while cisplatin improved life expectancy for a much longer time. Unfortunately, with the use of cisplatin, ovarian cancer patients started developing nerve and kidney damage. Clinical trials in the 1980s revealed that carboplatin was a less toxic version of cisplatin and it became the treatment of choice. In the 1990s, clinical trials showed that combining carboplatin and taxol increased survival and the combination became the standard of care.