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Randomized clinical trials (RCTs) are designed around a small number of pre-specified predicted values, including the trial’s hypothesized treatment effect, hypothesized control event rate, alpha, and power, knowing that these… Click to show full abstract
Randomized clinical trials (RCTs) are designed around a small number of pre-specified predicted values, including the trial’s hypothesized treatment effect, hypothesized control event rate, alpha, and power, knowing that these values are crucial to understanding trial results and for planning future studies. 2 For example, we would evaluate a null study that failed to meet planned enrollment goals differently than a null study that had a surprisingly low event rate. Here, we assess whether cardiovascular RCTs registered to ClinicalTrials.gov report key predicted values necessary for assessing the intended treatment effect.
Journal Title: Journal of General Internal Medicine
Year Published: 2020
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