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Featured Clinical Reviews

JAMA Guide to Statistics and Methods
March 1, 2022

Assessing Unexpected Circumstances That Lead to Modifications in Clinical Trial Design, Conduct, or Analysis: Application of the CONSERVE Reporting Guideline

Author Affiliations
  • 1Graduate School of Public Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 2Office of the Provost, University of Pittsburgh, Pittsburgh, Pennsylvania
JAMA. 2022;327(9):868-869. doi:10.1001/jama.2022.1748

In the COVID-19 Dexamethasone (CoDEX) randomized clinical trial, which studied a sample of critically ill patients with COVID-19, the use of dexamethasone significantly increased the number of ventilator-free days and was not associated with an increased risk of adverse events.1 During the course of the study, data from the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial became available and demonstrated benefit with dexamethasone in a comparable patient population.2 Members of the CoDEX independent data and safety monitoring committee (DSMC) recommended stopping the CoDEX trial because they did not consider it ethical to continue the trial as originally designed.

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