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Post-randomized consentAlso known as Zelen's design, this is an experiment design for randomized clinical trials proposed by statistician Dr. Marvin Zelen. In this design, patients are randomized to either the treatment group of the control group before being consented. Because we know which group a given patient is assigned to, consent can be sought conditionally. Additional recommended knowledge
OverviewIn this design, those patients receiving standard care need not be consented for pariticipation 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 issuesThere are a number of advantages conferred by the pre-randomization consent design.
Some disadvantages include:
Ethical issuesMore on ethical issues here. More on double post-randomized consent design. See also
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This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Post-randomized_consent". A list of authors is available in Wikipedia. |