What is a Clinical Trial?

Clinical trials are highly regulated studies of new treatments for a particular illness, which in our case means for lymphoma. Typically clinical trials come in 3 basic types, including Phase I, Phase II and Phase III.

Phase I
Studies are designed to look at the safety of a drug. In Oncology, this is the type of study where we try to find the highest, but safest dose for patients by slowly increasing the drug at set points in the study. The reservation for most patients is the fact that they may be receiving low doses of a drug. Phase 1 studies do produce meaningful responses in lymphoma.

Phase II
Studies are designed to investigate the effectiveness of the drug(s) and to further look at the safety profile of the new treatment. At this point, the investigators are looking at how effective the drug is in a defined setting.

 

Phase III
Studies are designed to test how the new treatment compares to the standard of care treatment for the disease being tested, and is usually randomized.

Data from these trials can be used to establish new standards of care for a disease, and are critical in identifying and characterizing the safety and efficacy of new drugs in development for the treatment of cancer. Every drug used today for the treatment, or supportive care of patients with cancer, has been studied on a clinical trial at one point or another. Importantly, data from well conducted clinical studies is used by the United States Food and Drug Administration (FDA) to determine the merits of making that drug available to all patients.