A Model of a Randomized Experiment with an Application to the Prowess Clinical Trial

18 Pages Posted: 19 Mar 2019 Last revised: 21 Feb 2021

See all articles by Amanda Kowalski

Amanda Kowalski

University of Michigan at Ann Arbor - Department of Economics

Date Written: March 2019

Abstract

I develop a model of a randomized experiment with a binary intervention and a binary outcome. Potential outcomes in the intervention and control groups give rise to four types of participants. Fixing ideas such that the outcome is mortality, some participants would live regardless, others would be saved, others would be killed, and others would die regardless. These potential outcome types are not observable. However, I use the model to develop estimators of the number of participants of each type. The model relies on the randomization within the experiment and on deductive reasoning. I apply the model to an important clinical trial, the PROWESS trial, and I perform a Monte Carlo simulation calibrated to estimates from the trial. The reduced form from the trial shows a reduction in mortality, which provided a rationale for FDA approval. However, I find that the intervention killed two participants for every three it saved. [This paper has been combined with “Counting Defiers” (www.nber.org/ papers/w25671) and superseded by “Counting Defiers: Examples from Health Care” (https://arxiv.org/abs/1912.06739) as of July 17, 2020.]

Suggested Citation

Kowalski, Amanda, A Model of a Randomized Experiment with an Application to the Prowess Clinical Trial (March 2019). NBER Working Paper No. w25670, Available at SSRN: https://ssrn.com/abstract=3354323

Amanda Kowalski (Contact Author)

University of Michigan at Ann Arbor - Department of Economics ( email )

Ann Arbor, MI
United States

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