What are Clinical Trials?

ACCESSING THE LATEST TREATMENTS

Virginia Cancer Institute is proud to bring Central Virginia access to clinical cancer trials that are going on across the country. In fact, our practice here in Richmond, Virginia, has clinical trial capabilities that rival those of major urban medical centers—yet you’ll have the security of being treated in a very personable and comfortable independent practice.

Clinical trials are studies that evaluate the effectiveness of new drugs or treatment strategies. The development of more effective cancer treatments requires that new and innovative therapies be evaluated with cancer patients. Each clinical trial is designed to find new or better ways to treat cancer patients. In oncology, clinical trials are especially important because, in the absence of high cure rates, nearly all therapeutic approaches are developmental in nature.

Currently, there are hundreds of ongoing clinical trials in the United States. Although clinical trials are an important component of cancer care and are crucial for improving cancer treatment, fewer than 5 percent of cancer patients currently participate. Many are uninterested or unaware that clinical trials exist. Some have difficulty finding an appropriate clinical trial that may benefit them. Others are ineligible to participate in clinical trials because of prior treatment interventions.

It is extremely important to decide whether or not to participate in a clinical trial before receiving any treatment from a physician.

What is a clinical trial?

A clinical trial is a research study designed to evaluate potential new treatment options. These studies are the result of a long and deliberate cancer research process that often takes years. Clinical trials test the safety and effectiveness of new or modified cancer drugs, new drug doses, unique approaches to surgery or radiation therapy, and varied combinations of treatments. Clinical trials are an integral component for improving the treatment of medical conditions, because they lead to higher standards of care. In the United States, all new cancer treatment products must proceed through an orderly clinical trials evaluation process to ensure that they have an acceptable level of safety and demonstrate benefit to helping patients with a specific cancer before they become commercially available to other patients.

Clinical trials essentially fall into two general categories.

1. The first general category of clinical trials is designed to evaluate new drugs, compounds or biologic agents that have not yet been approved by the Food and Drug Administration (FDA) for administration to patients. All substances must go through several phases of clinical trials to document their safety and effectiveness before the FDA approves them for routine use to treat cancer patients. Prior to FDA approval, these substances are available only through clinical trials; however, after FDA approval, they are commercially available.

2. Clinical trials may also evaluate drugs, compounds or biologic agents already approved by the FDA for the treatment of one type of cancer. These substances have already been determined to be safe by the FDA and they are now being evaluated in different doses, schedules and combinations to determine how to optimally use them for the treatment of a variety of cancers.

Virginia Cancer Institute Patient Information Brochure