Zelen's design


Zelen's design is an experimental design for randomized clinical trials proposed by Harvard School of Public Health statistician Marvin Zelen. In this design, patients are randomized to either the treatment or control group before giving informed consent. Because the group to which a given patient is assigned is known, consent can be sought conditionally.

Overview

In this design, those patients receiving standard care need not be consented for participation in the study other than possibly for privacy issues. On the other hand, those patients randomized to the experimental group are consented as usual, except that they are consenting to the certainty of receiving the experimental treatment only; alternatively these patients can decline and receive the standard treatment instead.
In comparison, the current predominant design is for consent to be solicited prior to randomization. That is, eligible patients are asked if they would agree to participate in the clinical trial as a whole. This entails agreeing to receiving the experimental treatment as a possibility, receiving the control treatment as a possibility, and the uncertainty involved in not knowing.

Statistical and epidemiological issues

There are a number of advantages conferred by the post-randomization consent design.
Some disadvantages include: