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Journal ArticleDOI

A New Design for Randomized Clinical Trials

Marvin Zelen
- 31 May 1979 - 
- Vol. 300, Iss: 22, pp 1242-1245
TLDR
This paper proposes a new method for planning randomized clinical trials, especially suited to comparison of a best standard or control treatment with an experimental treatment, which has the advantage that, before providing consent, a patient will know whether an experimental therapy is to be used.
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.

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References
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Journal Article

Statistical options in clinical trials.

Zelen M
- 01 Dec 1977 - 
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Is a randomized clinical trial experimental?

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.