A new design for randomized clinical trials.

Authors: Zelen M
Source: N Engl J Med. 1979 May 31;300(22):1242-5.
DOI: 10.1056/NEJM197905313002203 Publication date: May 31, 1979 E-Publication date: Not specified Availability: abstract Copyright: © 1979, Massachusetts Medical Society
Language: English Countries: Not specified Location: Not specified Correspondence address: Not specified


Article abstract

This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients in the first group receive standard treatment; those in the second 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 second group, regardless of treatment, are compared with those in the first 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 is to be used.

Find it online