The development of novel agents for the treatment of colorectal cancer: a critical review of current practice and some suggestions for the future.

The pathways to approval of new therapeutic agents in the United States and globally rely on the performance of well-designed clinical trials demonstrating both safety and efficacy. We recognize that the last decade has seen some great successes in improving outcomes for patients with cancer and, specifically, for patients with colorectal cancer. The development of novel agents active in colon cancer has led to improved survival and cure rates. However, because of the number of agents now available and the established practice patterns, it is becoming increasingly difficult to test new agents in cancer, particularly in colorectal cancer. The focus of this article is to review the current clinical trial designs with a critical eye and propose novel approaches to bringing new agents into the armamentarium of agents effective against colorectal cancer. Our current standards for drug development are increasingly problematic, and it is imperative that we develop new expectations and supporting standards in cancer drug development.