NEW DESIGN FOR RANDOMIZED CLINICAL-TRIALS

A new method for planning randomized clinical trials is proposed. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into 2 groups by a random or chance mechanism. Patients in the 1st group receive standard treatment; those in the 2nd group are asked if they will accept the experimental therapy; if they decline, they receive the best standard treatment. In the analyses of results, all those in the 2nd group, regardless of treatment, are compared with those in the 1st group. Any loss of statistical efficiency can be overcome by increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage that, before providing consent, a patient will know whether an experimental treatment will be used.