Approximately 555,550 people in the United States are expected to die of cancer each year - an average of more than 1,500 people a day. As the second leading cause of death after heart disease, cancer accounts for one in four deaths each year. Moreover, about 1,284,900 new cancer cases are expected to be diagnosed in 2002. As widespread as the threat of cancer is among all Americans, its impact is felt disproportionately by racial and ethnic minorities, the medically underserved, and people over age 65.

Scientific research continues to provide valuable insights into the causes of cancer. But research is an incremental process, moving forward in small, carefully planned steps. Advances typically begin with basic research in the laboratory. After years of testing in cells and tissues, promising leads are tested in animal models of human cancers. Only after treatments or techniques prove successful in animals can they be evaluated in people through clinical trials. Well-designed, well-run clinical trials are the only way to determine the true effectiveness of a promising new agent or intervention being investigated.

Clinical trials are designed to answer specific questions about the effects of a therapy or technique designed to improve human health. The trials are planned in advance, follow a rigorous scientific process, and the findings are analyzed. The scientific process has built-in safeguards for participants, who are selected carefully from volunteers. Clinical trials are usually conducted in a progressive series of steps, called phases. The process starts with small trials testing the safety of an intervention and moves to progressively larger trials. The larger trials compare the effectiveness of the new intervention given to the investigational group to the currently accepted standard care given to the control group.

Clinical trials are mechanisms for developing better methods of detecting, treating, and eventually preventing diseases like cancer. The enormous strides made in treating childhood cancer, for example, are the direct result of clinical trials. In the United States today, more than 70 percent of children with cancer live at least 5 years after diagnosis, as opposed to only 55 percent in the mid-1970s.

More than 60 percent of children with cancer participate in clinical trials, yet only 3 percent of adults with cancer do. To answer the most pressing questions about cancer - and to do so quickly - many more adults must participate in clinical trials. To encourage participation, the National Cancer Institute (NCI) and other organizations provide information to ensure that health care professionals and the people they treat understand clinical trials, consider them as an option, and can easily locate them in their communities. Clinical trials should not be considered only in terms of caring for people who have cancer. They may also present prevention and early detection options for people at high risk of developing cancer.

For more basic information about clinical trials, see "Facts and Figures about Cancer Clinical Trials."

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