Medical Letter on the CDC & FDA
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Clinical Trial Research
Findings from Baylor College of Medicine, College of Medicine broaden understanding of clinical trial research
June 21st, 2009
According to recent research from the United States, "Many early phase trials in stroke have not been subsequently confirmed. Randomization balance in baseline factors that influence outcome are difficult to achieve and may be partly responsible for misleading early results." "We hypothesized that comparison with an outcome function derived from a large number of pooled control arms would mitigate these randomization problems and provide a reliable predictor for decision-making before proceeding to later phase trials. We developed such a model and added a novel feature of generation of multidimensional 95% prediction surfaces by which individual studies could be...
Source: Medical Letter on the CDC & FDA (2009-06-21)
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