James Metz, MD
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 1, 2001
This article is archived for reference only. For more current information, please visit Clinical Research Trials: The Basics.
There are clinical research trials that are ongoing for almost every type of cancer. Clinical trials are experiments to determine the value of specific treatments. There are international, national, and institutional research trials. Each clinical research trial must be approved by an Institutional Review Board (IRB) which is composed of physicians, researchers, and even people not involved in medicine. The IRB decides if the study is reasonable, appropriately designed, and safe for the patient population. Anyone considering joining a clinical research trial must be fully informed about the trial details, benefits, and risks. All patients must sign informed consent. Trials may involve chemotherapy, radiation therapy, surgery, new experimental modalities, or any combination of these treatments.
There are different types of clinical trials that are divided into the following phases:
Phase I clinical trials attempt to determine the dose of a drug that is appropriate. Phase I trials typically include patients that have advanced disease, which is resistant to standard treatments. The dose is typically increased as additional patients are added on the study to determine the maximum tolerated dose.
Phase II trials 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.
Clinical research trials are extremely important in expanding treatment options in all cancers. The treatments that are available today are due to the participation of other cancer patients in clinical research trials. We are 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 this disease. OncoLink strongly recommends patients discuss any clinical research trials for which they may be eligible with their oncologist.