Definitive therapeutic trials are expensive and tedious and may be so prolonged that aspects of treatment have been superseded by the time a result is obtained. A single trial, however well-designed, executed and analysed, can only answer the question addressed. The Regulatory Authorities give guidance as to the number and design of trials that, if successful, would lead to a therapeutic claim. But changing clinical practice in the longer term depends on many other factors, of which confirmatory trials in other centres by different investigators under different conditions are an important part.
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