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

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

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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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Corresponding Author: Stephen R. Wisniewski, PhD, Office of the Provost, University of Pittsburgh, 817 Cathedral of Learning, 4200 Fifth Ave, Pittsburgh, PA 15260 (stevewis@pitt.edu).

Conflict of Interest Disclosures: Dr Brooks reports serving on the DSMB for Cerus Corporation. No other disclosures were reported.

References
1.
Tomazini  BM , Maia  IS , Cavalcanti  AB ,  et al; COALITION COVID-19 Brazil III Investigators.  Effect of dexamethasone on days alive and ventilator-free in patients with moderate or severe acute respiratory distress syndrome and COVID-19: the CoDEX randomized clinical trial.   JAMA. 2020;324(13):1307-1316. doi:10.1001/jama.2020.17021PubMedGoogle ScholarCrossref
2.
Horby  P , Lim  WS , Emberson  JR ,  et al; RECOVERY Collaborative Group.  Dexamethasone in hospitalized patients with Covid-19—preliminary report.   N Engl J Med. 2021;384(8):693-704. doi:10.1056/NEJMoa2021436PubMedGoogle Scholar
3.
Orkin  AM , Gill  PJ , Ghersi  D ,  et al; CONSERVE Group.  Guidelines for reporting trial protocols and completed trials modified due to the COVID-19 pandemic and other extenuating circumstances: the CONSERVE 2021 statement.   JAMA. 2021;326(3):257-265. doi:10.1001/jama.2021.9941PubMedGoogle ScholarCrossref
4.
Schulz  KF , Altman  DG , Moher  D ; CONSORT Group.  CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.   BMC Med. 2010;8:18. doi:10.1186/1741-7015-8-18PubMedGoogle ScholarCrossref
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Chan  AW , Tetzlaff  JM , Altman  DG ,  et al.  SPIRIT 2013 statement: defining standard protocol items for clinical trials.   Ann Intern Med. 2013;158(3):200-207. doi:10.7326/0003-4819-158-3-201302050-00583PubMedGoogle ScholarCrossref
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Girardis  M , Busani  S , Damiani  E ,  et al.  Effect of conservative vs conventional oxygen therapy on mortality among patients in an intensive care unit: the Oxygen-ICU randomized clinical trial.   JAMA. 2016;316(15):1583-1589. doi:10.1001/jama.2016.11993PubMedGoogle ScholarCrossref
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Eisenberg  MJ , Hébert-Losier  A , Windle  SB ,  et al; E3 Investigators.  Effect of e-cigarettes plus counseling vs counseling alone on smoking cessation: a randomized clinical trial.   JAMA. 2020;324(18):1844-1854. doi:10.1001/jama.2020.18889PubMedGoogle ScholarCrossref
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