According to Ronald H. Lands, M.D., an oncologist/hematologist on the medical staff of Methodist Medical Center of Oak Ridge, "Clinical trials are responsible for most of the advances in oncology." Dr. Lands is board certified in oncology and hematology, internal medicine, geriatrics, and palliative care.

The clinical trial process begins in a laboratory, where scientists develop and test new drugs or the rationale for combinations of drugs, he explained. When a particular research treatment appears promising, a Phase I study involving humans begins.

Phase I participants consist of a small number of patients whose cancer has not responded to any known useful treatment. Patients receive the new drug, and scientists analyze the results to determine any biologic effects and the maximum tolerated dose.

"When the human dose has been defined by Phase I treatments, Phase II studies may begin," Dr. Lands said. "Patients with various types of cancer participate in Phase II. Scientists evaluate the results of their treatments and determine which, if any, cancers responded."

Studies of treatments that show promise against a specific cancer continue in Phase III. During this phase, patients continue to receive the drug or drugs, and scientists compare the new, and hopefully better, treatment with standard treatment.

"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," he noted. "The trial then stops and researchers analyze the data." However, if it becomes clear that a treatment does not help, patients are removed from it just as they would be in standard therapy.

Participants in clinical trials are usually followed for life. Information concerning their survival and quality of life is pooled and analyzed with information about other participants throughout the country, Dr. Lands said.

In the past, access to clinical trials was limited to patients who lived near or could travel to one of the relatively few academic centers that conducted these studies. "In recent years, oncologists have filtered away from academic centers and established practices in smaller communities. Networks of community hospitals and medical centers began to grow, and clinical trials became accessible to more people," he explained.

Today, several large organizations coordinate clinical trials throughout the United States. These groups include large national networks of cancer centers, which sponsor the same protocols at network medical centers.

Patients of Thompson Cancer Survival Center at Methodist in Oak Ridge and Thompson Cancer Survivor Center in Knoxville receive the benefits of a clinical trial network. The two cancer centers are part of the Covenant Health Oncology Research Team, which works closely with Southwest Oncology Group (SWOG). Because of this relationship, Methodist and Thompson can pool their patients in some of the protocols sponsored by this network.