Article ID Journal Published Year Pages File Type
2162413 Seminars in Oncology 2011 7 Pages PDF
Abstract
This article seeks to address the question: Is best supportive care (BSC) in research a euphemism for no care or a standard of good care? The data regarding the ethical and methodological validity of BSC studies are reviewed. Most of the BSC studies published over the past 25 years are really treatment versus no treatment studies represented as BSC studies. By ignoring the best contemporaneous standards of BSC, standardizing practices in multicenter studies, validating participating centers, or documenting treatment delivery, researchers belie the stated intention of studying BSC. Most studies sought to evaluate if there was any benefit of a new anti-tumor treatment versus discontinuation of anti-tumor therapies. Overwhelmingly, and with few exceptions, the impact of BSC practices was not really part of the key research question. To be ethical and methodologically valid, BSC studies must incorporate standards consistent with contemporaneous, proven BSC practice standards. Work is underway to develop widely validated standards of practice for the control arm of best supportive care studies. These can be readily incorporated in to study development and evaluation.
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