Roundtable discussion. Investigational exclusion, clinical trials, and cancer.

Clinical trials are critical for developing and testing new treatments for cancer, but a panel of experts agreed that the state of clinical trials in the United States today is a "mess." How did we get into this situation in the first place, and how can we extricate ourselves? Should the federal government assume greater responsibility for funding and overseeing clinical trials and for establishing a standard health benefit package that defines the right to participate in clinical trials? The panel explored whether decisions to exclude patients are based on medical necessity and scientific merit or on the bottom line; whether insurance companies promise more than they can deliver; whether pharmaceutical companies are doing their share; and why lawyers are getting any share. In the end, the participants expressed hope that we, as a society, can get clinical trials back on track to serve their legitimate scientific and medical purposes.