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Related Experiment Video

Updated: Jun 24, 2026

Standardized Model of Ventricular Fibrillation and Advanced Cardiac Life Support in Swine
05:36

Standardized Model of Ventricular Fibrillation and Advanced Cardiac Life Support in Swine

Published on: January 30, 2020

Is "rescue" therapy ethical in randomized controlled trials?

Richard Holubkov1, J Michael Dean, John Berger

  • 1Department of Pediatrics, Pediatric Critical Care, University of Utah, Salt Lake City, UT, USA. rich.holubkov@hsc.utah.edu

Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
|March 25, 2009
PubMed
Summary

Rescue therapy in pediatric trials is ethically complex. Allowing it may obscure drug efficacy, increase sample sizes, and ethically compromise trials, potentially harming more children.

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Last Updated: Jun 24, 2026

Standardized Model of Ventricular Fibrillation and Advanced Cardiac Life Support in Swine
05:36

Standardized Model of Ventricular Fibrillation and Advanced Cardiac Life Support in Swine

Published on: January 30, 2020

Area of Science:

  • Critical Care Medicine
  • Clinical Trial Design
  • Medical Ethics

Background:

  • Randomized controlled trials (RCTs) in pediatric critical care often face ethical dilemmas regarding patient deterioration.
  • The practice of incorporating 'rescue therapy' (open-label active drug administration) during RCTs is common but ethically and analytically challenging.
  • Misconceptions about rescue therapy can misrepresent its impact on trial integrity and ethical considerations.

Purpose of the Study:

  • To examine the ethical, conceptual, and analytic challenges of rescue therapy in pediatric randomized trials.
  • To analyze the implications of rescue therapy on equipoise and intention-to-treat (ITT) analysis.
  • To evaluate the impact of rescue therapy on trial outcomes, sample size, and ethical considerations in pediatric critical care.

Main Methods:

  • A narrative review of the literature on rescue therapy in clinical trials.
  • Examination of ethical principles, the concept of equipoise, and ITT analysis.
  • Application of these concepts to a hypothetical RCT of corticosteroids versus placebo in pediatric septic shock.

Main Results:

  • Rescue therapy, while seemingly compassionate, conflicts with the principle of equipoise, questioning the study drug's true efficacy.
  • If rescue therapy is used, ITT analysis can only compare immediate versus delayed treatment, not the drug's inherent effect.
  • Permitting rescue therapy can diminish the observed treatment effect, necessitating larger sample sizes and potentially increasing patient risk, including mortality.

Conclusions:

  • While perceived as ethically necessary, rescue therapy in RCTs raises ethical concerns due to its inconsistency with equipoise.
  • Trials with rescue therapy require larger sample sizes, exposing more children to study risks, including potential death.
  • Such trials cannot definitively ascertain a treatment's overall efficacy or harm, only the effects of immediate versus delayed administration.