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By Gurpreet Dhillon

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It is essential that in a clinical trial, the number of hypotheses are limited and stated in advance. 00001). He was brought to trial and convicted because he had misused his position as village postmaster to antedate his postal bets after he knew which horses had won their races. ” An exploratory study would describe the various races and the characteristics of the horses by the order they reached the finish line. This information could then be used to generate ideas about which horses represented good bets in future races.

63 associations between mean changes in LDL and HDL cholesterol and risk of coronary events, one would have predicted a treatment benefit of approximately 30%. 4 In the first year, there was even a trend towards an excess number of fatal and non-fatal coronary events in women receiving active therapy. This study shows that drugs may have many different mechanisms of action and that relying on a single surrogate (improved lipid profile) can be very misleading. The inverse association between bone density and bone fractures is another example of the disparity between theory and reality.

Such imbalances, which can favor either group, may contribute to observed treatment-control group differences. For this reason, the FDA often requires that findings from one trial be confirmed in a second independent trial of similar design, unless the treatment differences are very large. Can group differences be controlled for? Another way of dealing with group imbalance at baseline is by statistical adjustment for the imbalance of prognostic factors across treatment groups at the end of the trial.

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