
Use of Run-in Periods in Randomized Trials With Dr Armitage
JAMAevidence JAMA Guide to Statistics and Methods
The Disadvantages of Randomised Trials
The criticism that people will quite often raise is that you lose generalizability for the result. Even without a run-in, trial participants tend to be healthier. So what are the disadvantages of this approach? If this increases our ability to preserve our power in the trial and get a reliable or robust answer, why wouldn't you always do this? Well, it's really mainly relevant to longer-term trials. Trials where you need to get your treatment to the patient very rapidly, acute disease, for example, isn't relevant.
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