Trends in clinical trials in surgical oncology: implications for outcomes research.

Outcomes analysis is emerging as a crucial tool in understanding and improving health care. To this end, outcomes research is focused on methodologies for assessing the impact and quality of clinical services and the penetration of new findings. Clinical trials are an important mechanism for generating data to support outcomes research activities. In clinical trials in surgical oncology, there has been a general broadening of the spectrum of end points that are more focused on the needs of providing data to outcomes researchers. For example, in addition to traditional "mechanical" end points reflecting the physical dimensions of disability, awareness of the importance of end points related to quality of life has increased. Moreover, a variety of innovative study designs and methodologies have found more widespread use, including noninferiority trials, preresection staging designed to direct therapy more precisely, planned early reports of conditional results, prognostic studies, assessment of an event status at a point in time, and large simple trials. The goal of this article is to summarize and assess some of the trends in clinical trials in surgical oncology. Examples of ongoing studies or of trials in development from the American College of Surgeons Oncology Group are discussed.