Because of the lack of a survival benefit, the suboptimal control arm design, and the overall health care costs, the authors do not believe that olaparib represents a major advance for patients with pancreatic cancer. The POLO trial illustrates that as a community, even in settings where there is a huge need, physicians must be rigorous in their methodology and mindful that they not lower the bar for new therapies.
What qualifies as disease in clinical trials may be getting so broad that outcomes are becoming less meaningful and harder to interpret, argue Go Nishikawa and Vinay Prasad
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