Clinical trials are experiments to determine the value of specific treatments. There are international, national, and institutional research trials. In order for a study to be considered a clinical research trial it must be approved by an Institutional Review Board (IRB) which is composed of physicians, researchers, and consumer advocates. The IRB decides if the study is reasonable, appropriately designed, and safe for the patient population.
Before joining a clinical research trial, you must be informed about the trial details, all of the benefits, and all of the risks. Physicians must inform patients completely and all participants must sign informed consent documents which outline all of the details of the trial. Trials may involve any possible treatments for cancer including but not limited to: chemotherapy, radiation, surgery and even alternative and complimentary treatments.
For a listing of clinical trials open to enrollment, click here.
Phases of Clinical Trials
Clinical trials are research studies that are divided into three phases. Each phase is designed to find out certain information, building on information from the earlier phase:
Phase I clinical trials attempt to determine the appropriate dose of drug to be administered. Phase I trials typically include patients with the most advanced stages of disease, which might be resistant to standard treatments. The dose is typically increased as additional patients are added into the study to determine the maximum tolerated dose. Phase I trials primarily test the safety of an experimental drug in very few patients.
Phase II trials test some short-term effectiveness but mainly test the drug's safety and identify effective dosages using greater numbers of patients. They attempt to measure the biologic response of a particular tumor to a specific treatment. Typically patients with a tumor for which there is not an effective therapy are included in phase II trials of single agents. Combination regimens may also be evaluated in phase II trials. The goal of a combination regimen phase II trial is to ensure that the treatment is feasible, safe, and promising enough before expanding to the next phase.
Phase III trials are designed to compare an experimental treatment to an accepted standard of care and evaluate endpoints such as survival and symptom control. These trials typically are performed in multi-institutional settings that include physicians from the community. They test the safety, effectiveness and dosage in a large number of patients. Only after a successful Phase III trial will the Federal Drug Administration (FDA) consider the approval of a drug for use in certain populations.
Why Participate in a Clinical Trial?
Clinical research trials are extremely important in expanding treatment options in all cancers. It is especially important that young survivors participate in clinical trials. There is very little information available to young women diagnosed with breast cancer. If those of us who are eligible participate in clinical trials with post menopausal women, then physicians will be able to see how the drug behaves differently or similarly in the pre-menopausal woman. The treatments that are available today are due to the participation of other cancer patients in clinical research trials. The medical community is constantly trying to identify better treatments to cure cancer. There are also studies to identify less toxic treatments or agents, which can protect the normal tissues and minimize side effects of treatment. Clinical research trials are very rewarding for both the patient and the physician. The patient may benefit from new treatment options and help future cancer patients in their fight against cancer.
Increased clinical trial participation makes a difference. For example, mortality in childhood cancers has dropped 57% since the early 1970's. It is no coincidence that 70% of cancer patients under age 19 participate in clinical trials. Only 1.5% of patients 50 and older participate in clinical trials. In order to discover better ways of detecting, preventing, treating and curing cancer we depend on cancer patients participating in clinical trials.
For a listing of clinical trials open to enrollment, click here.
