Bias and Conditioning in Sequential Medical Trials

Philosophy of Science 80 (5):1053-1064 (2013)
Randomized Controlled Trials are currently the gold standard within evidence-based medicine. Usually, they are conducted as sequential trials allowing for monitoring for early signs of effectiveness or harm. However, evidence from early stopped trials is often charged with being biased towards implausibly large effects. To our mind, this skeptical attitude is unfounded and caused by the failure to perform appropriate conditioning in the statistical analysis of the evidence. We contend that a shift from unconditional hypothesis tests in the style of Neyman and Pearson to conditional hypothesis tests gives a superior appreciation of the obtained evidence and significantly improves the practice of sequential medical trials, while staying firmly rooted in frequentist methodology
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DOI 10.1086/673732
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John Worrall (2008). Evidence and Ethics in Medicine. Perspectives in Biology and Medicine 51 (3):418-431.
Cecilia Nardini (2013). Monitoring in Clinical Trials: Benefit or Bias? Theoretical Medicine and Bioethics 34 (4):259-274.

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