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Guyatt G, Rennie D, Meade MO, Cook DJ
Part B Therapy
Chapter 9.3. Randomized Trials Stopped Early for Benefit
Victor Montori, P. J. Devereaux, Holger Schünemann, Maureen O. Meade, Deborah J. Cook, Gordon Guyatt
Although statistical simulation can readily demonstrate how truncated RCTs will overestimate...


Topics Discussed: randomized controlled trials, randomized controlled trials, truncated, stopping rules, treatment effect, truncated studies

Excerpt: "Taking the point estimate of the treatment effect at face value will mislead if the decision to stop the trial resulted from catching the apparent benefit of treatment at a random high. Consider a hypothetical set of RCTs testing a treatment with a true, but modest, underlying benefit. Even early in their conduct, results will cluster around the true effect (Figure 9.3-1). Even so, half these trials will, by chance, overestimate the true effect and half will underestimate the true effect (Figure 9.3-1). In some, the overestimates and underestimates will be large. The smaller the number of events, the greater the risk that the play of chance will result in apparent effects far from the truth (Figure 9.3-1)...."
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