What is it about?
The article uses two trials, one large and the other small, to make some points about randomisation.
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Why is it important?
The trial of TGN1412 is a small trial in 8 healthy volunteers where it is clear that the randomisation-based analysis is inadequate. The TARGET study is a very large trial involving more than 18,000 patients where it is clear that departing from the randomisation based analysis is dangerous. Looking at the problem in turns of bias-variance trade-offs reconciles the two cases. Some lessons are drawn.
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This page is a summary of: Lessons from TGN1412 and TARGET: implications for observational studies and meta‐analysis, Pharmaceutical Statistics, April 2008, Wiley,
DOI: 10.1002/pst.322.
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