A cancer treatment trial tests new treatment options for people with cancer, with the goal of finding a better way to treat the cancer. The clinical trial may test new drugs, new combinations of drugs or radiation therapy techniques.
A clinical trial is a long careful research process that begins in the laboratory where the scientists first develop and test their ideas. If the new treatment looks promising, the next step is animal testing to assure no harmful effects. The next step is to test the new treatment with human subjects. Testing has three phases. Phase I tests are done in the major research centers with only a limited number of people to check for harmful side effects. When the new treatment has been determined as safe it is ready for the next phase. Phase II tests for effectiveness of the new treatment. Phase III compares the present standard treatment for cancer and compares it to the new treatment to see which one is better.
Process for Treatment Trials
To partake in a cancer treatment trial, a patient must first be eligible for the trial. The medical oncologist or radiation oncologist may determine that a person might be a candidate for a trial. The patient is then asked if they are interested in learning more about the trial and the study. An informed consent is reviewed with the patient to make sure they understand the treatment, the risks and the benefits. The eligibility checklist is reviewed to make sure the patient can enroll in the study. Baseline x-rays and laboratory testing is done before beginning treatment. A process called randomization is done via the computer to choose the treatment group. The new cancer treatment is given to the patient. The doctors and nurses monitor the patient for side effects and effectiveness of the new therapy. Many studies offer a quality of life component, which asks the patient about how he or she is tolerating the treatment. Extra tissue from a patients' surgery may be sent to a laboratory for extra testing or storage for future testing.
Clinical Trial Patient Rights
The rights of the clinical trial patient are guarded very closely. Before entering a trial, the patient is informed of the pros and cons of the study. He is also able to withdraw from the study at any time. Information about the patient is kept very confidential with numbers as identifiers.
The cost of participation in a clinical trial is often a concern. It is best to check with your insurance provider to see if your plan covers clinical trials. To learn more about resources for cost for Clinical Trials go to: http://www.nci.nih.gov, "Clinical Trials and Insurance Coverage-A Resource Guide."
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