Clinical Trial
Independence of statistician who analyses unblinded data discussed
Published in Medical Letter on the CDC and FDA, July 18th, 2004
"This discussion considers arguments for and against separating responsibility for the unblinded interim analysis of a clinical trial from responsibility for trial management and modifications to the ongoing trial," investigators in the United States report.
"The degree to which one or different statisticians carry out these responsibilities and thus the degree of statistician independence for the two activities can vary, but a sponsor should recognize that giving a single statistician both responsibilities might...
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