ODAC Clarifies Standards for Maintenance In Ovarian Cancer; Nixes Olaparib in 11-2 Vote

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Some of the questions that landed the AstraZeneca drug Olaparib (lynparza) before the FDA Oncologic Drugs Advisory Committee were classic:

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I have spent over 20 years running a tumor imaging metrics core at an academic cancer center. In that time, I have watched clinical trial enrollment concentrate at a relatively small number of flagship academic institutions. Unfortunately, trials do not propagate well to the community sites where most patients prefer to receive care. The explanations usually offered for why this happens have never fully accounted for what I observed.
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Tessa Vellek
Tessa Vellek

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