Comparative effectiveness research: opportunities in surgical oncology.

Comparative effectiveness research (CER) is especially applicable to surgical oncology because of the numerous challenges associated with conducting surgical randomized controlled trials, and the opportunity to apply various CER methodologies to answer surgical questions. In this article, several past randomized trials or attempted trials are described to demonstrate challenges related to feasibility, patient selection and generalizability, and timeliness trial results to inform clinical practice. Thus, there is a gap between these "efficacy" studies (ie, randomized trials) and "effectiveness" research, which is performed in a less controlled setting (not randomized) but is able to examine patient outcomes in the "real world." Retrospective analyses and pragmatic trials are other important methods for answering CER questions in surgical oncology, with examples of these studies being conducted in prostate, breast, and rectal cancers. Multiple current initiatives by the American College of Surgeons and the Alliance for Clinical Trials in Oncology continue to expand the infrastructure for CER in surgical oncology.