Commentary: Randomized Controlled Trials




In 2002, the fellows and staff at Memorial Sloan-Kettering put together an issue of Surgical Oncology Clinics of North America on randomized clinical trials in oncology. At that time, I emphasized the importance of that endeavor and expressed the hope that the results of such trials would translate into meaningful changes in practice. The present symposium reviews trials performed since that time. What progress has been made in randomized controlled trials since 2002? A broad table of disease-specific sites is examined and one is challenged as to whether the glass is half full or half empty. On one hand, we have, as a community, embraced the concept of randomized control trials as less than perfect, but the best alternative to evaluate clinical practice. We have come to realize that trials are both a gift and a curse. Those well done, well stratified, with adequate numbers and appropriate end points, generally add to what we know about the efficacy, or lack thereof, of what we do. Others, while idling behind the euphemism of “randomized,” are little more than efforts in sciolism.


We imagined 8 years ago that this was a start. Has there been any progress? When one looks at the relative dearth of meaningful trials, the glass appears too empty, but important surgical questions have been addressed, as in the case, for example, of melanoma. The more troublesome question, however, is: Why do trials, when even if well done, fail to change behavior? At this stage in my career, I would settle for them provoking the willingness to think, the willingness to question, and the willingness to change. I have great faith in the present generation, as represented by the authors of this text, but then again I have had great faith in their colleagues at all stages of their earlier careers. Why do we find it so difficult to change? Why is it that we cannot accept that nasogastric tubes are unnecessary for routine upper gastrointestinal malignancy? Why is it that we have such difficulty accepting that 100 mL of water will not change significantly the 800 mL of saliva that disappears down into the partially or completely resected stomach? Why do we continue to punish all patients with mechanical bowel preparation? Why do we justify adjuvant treatment for pancreas cancer based on underpowered trials performed 30 years ago as a substitute for investigational approaches to this lethal disease?


The authors provide an excellent summary of randomized trials in multiple areas, but unless we take the next step and find out why we are not willing to challenge our self-conceived notions even when randomized trials suggest that we should, then once again we will lose the opportunity to make the kind of progress we all desperately want.


This seminar series provides information that should allow realistic judgments to be made. These summaries, by a cadre of young, enthusiastic, and thoughtful surgical oncologists, should challenge us all to continue our lifelong education. Fellowship is not a finishing school, just a methodology to gain the tools to continue to grow.


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Sep 27, 2017 | Posted by in ONCOLOGY | Comments Off on Commentary: Randomized Controlled Trials

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