Comparing treatments

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Abstract
In the United States the Food and Drug Administration, historically, has required evidence from two placebo controlled trials before licensing a new compound, although some recent approvals have been based on a single trial.1 2 Although these regulatory requirements have been criticised, they generally provide us with good evidence that the drug works under specified conditions. It is often less clear how well the drug will work under different conditions and in patients who do not resemble those in the trials. Less attention has been paid to the scientific principles of generalisation than to those that underpin the conduct …