Prospective Safety Plans Needed In Clinical Trials, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Sponsors should prospectively think about how to categorize and analyze organ-specific outcomes, FDA Office of Biostatistics Director O'Neill says at Drug Information Association meeting in Lisbon, Portugal. The need for more routine collection of cardiovascular safety data is one lesson learned from the COX-2 inhibitor experience, he says.
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