There are very few controlled trials of treatment of liver disease in either adults or children. This is unfortunate because there are considerable uncertainties surrounding the effectiveness of the treatments in use. However, controlled trials present considerable difficulties to investigators in terms of organization and maintenance of enthusiasm. In order to gain the maximum information from trials it is imperative to categorize patients accurately. The planning of the trial requires an infinite attention to detail. The plan should be as simple as is possible to answer the questions. It is important that controlled trials should be restricted to 2 years, duration wherever possible. This allows the investigator's interest to be maintained. In planning trials, it is important to remember that when the trial is mounted, the recruitment of patients is often considerably less than that which was expected. Because of the inadequacy of knowledge of effectiveness of treatment in liver disease it appears to be unethical to do anything other than controlled trials, henceforth.
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