Do Clinical Trials Belong in Clinical Guidelines?

Author: Harold J. Burstein MD, PhD
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NCCN guidelines are notable for their comprehensive, maybe even exhaustive, nature. The goal of the guidelines is to create a template for most conceivable common clinical circumstances. Some nodal points in the guidelines are supported by high-quality evidence from randomized clinical trials. Others are supported by lesser data, expert opinion, or, in certain instances, the best guess of clinical experts. A great strength of the guidelines is that they patch together these decision points; those reinforced by strong ropes of data and those held by more tenuous lines of judgment.Such thoroughness is very useful in clinical practice, both in high-volume clinical situations in which clinicians are often quite experienced, and arguably even more so in low-volume clinical circumstances, that are often unfamiliar to practicing oncologists, who refer to guidelines for real guidance. This thoroughness creates somewhat of an illusion, however, that NCCN guidelines panel members always know the right thing to do next, that little uncertainty exists, or that things couldn't be done better.This is rarely the case in oncology, of course, which is why clinical trials are needed. NCCN guidelines always recommend consideration of clinical trials. In fact, the introduction to all the disease-based guidelines states:The NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.Although these sentiments are widely accepted throughout the NCCN and larger oncology community, participation rates in clinical trials remain dismal. In the United States, fewer than 5% of...

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Harold J. Burstein, MD, PhD, editor-in-chief of JNCCN, is an Associate Professor of Medicine at Harvard Medical School and a medical oncologist at Dana-Farber Cancer Institute and Brigham & Women's Hospital. He is a clinician and clinical investigator specializing in breast cancer.

Dr. Burstein attended Harvard College and earned his MD at Harvard Medical School, where he also earned a PhD in immunology. He trained in internal medicine at Massachusetts General Hospital and was a fellow in medical oncology at Dana-Farber before joining the staff.

Dr. Burstein's clinical research interests include novel treatments for early- and advanced-stage breast cancer and studies of quality of life and health behavior among women with breast cancer. He has written widely on breast cancer in both traditional medical journals and on the web, including New England Journal of Medicine and Journal of Clinical Oncology. International committees focusing on cancer treatments that he has or continues to participate in include the NCCN Clinical Practice Guidelines Breast Cancer Panel, St. Gallen Breast Cancer Panel, CALGB Breast Cancer Committee, ASCO Health Services Research and Clinical Research Committees, the National Quality Forum Breast Cancer Technical Panel, and other ASCO expert panels.

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