What Are Clinical Trials? Studies that compare various possible treatments for particular medical disorders are called clinical trials. These studies benefit all areas of medicine, but are especially useful in evaluating new or improved treatments for people with cancer. "Clinical trials are responsible for most of the advances in oncology," according to Ronald H. Lands, M.D., an oncologist/hematologist on the medical staff of Methodist Medical Center of Oak Ridge. Dr. Lands is board certified in oncology, hematology, internal medicine, geriatric medicine, and hospice and palliative medicine. "The process begins in the laboratory, where scientists develop and test new drugs or the rationale for combinations of drugs. When a particular research treatment appears promising, a Phase I study involving humans begins. "Patients whose cancer has not responded to all other known useful treatments receive the drug or drug combination in order to determine the safety and human tolerance of it," Dr. Lands explained. When scientists identify the human dose range for the drug or drugs they are studying, Phase II of the clinical trial begins. Patients with a variety of cancers enter the study and undergo the new treatment. Scientists then study the results to determine whether some cancers respond better than others do. Treatments that show promise against specific cancers usually move to the next stage of study, Phase III, he said. Patients continue to receive the drug or drugs, and scientists compare the new treatment and the standard treatment. If the treatment is clearly not helping, participants are removed from it, just as they would be in standard therapy. "Patients are enrolled continuously in a clinical trial until there is evidence that a clear benefit exists or the target number of patients is accrued," according to Dr. Lands. "The trial then stops and researchers analyze the data." Participants in clinical trials are followed for life. Information concerning their survival and quality of life is pooled with information on other participants throughout the United States. In the past, patients enrolled in clinical trials tended to live near or could travel to a small number of academic centers that performed the studies. The situation began to change when oncologists started leaving the academic centers and establishing practices in smaller communities. "Networks of community hospitals and medical centers began to grow, and clinical trials became accessible to more people," Dr. Lands explained. Today, large national networks of cancer centers and small regional affiliations coordinate clinical trials throughout the United States. The large national networks sponsor the same protocols at network medical centers, while the smaller regional affiliations form at the direction of an academic center.

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