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Comparative effectiveness research: what to do when experts disagree about risks.

Reidar K Lie1, Francis K L Chan2, Christine Grady3

  • 1Department of Philosophy, University of Bergen, Sydnesplassen 12, 5020, Bergen, Norway. Reidar.lie@uib.no.

BMC Medical Ethics
|June 21, 2017
PubMed
Summary
This summary is machine-generated.

Ethics Review Committees (ERCs) should evaluate comparative effectiveness research by assessing expert disagreement, not just when evidence is unknown. This ensures accurate risk assessment for clinical trials.

Keywords:
EquipoiseResearch ethicsResearch ethics reviewRisk judgmentsStandard of care

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Area of Science:

  • Medical Ethics
  • Clinical Research Oversight
  • Health Services Research

Background:

  • Comparative effectiveness research (CER) compares existing medical standards of care.
  • Ethical considerations in CER are increasingly important.
  • Ethics Review Committees (ERCs) face challenges in evaluating CER risks.

Purpose of the Study:

  • To reframe the ethical evaluation of CER beyond the "nothing is known" criterion.
  • To provide guidance for ERCs on assessing risks in CER, particularly when expert opinions diverge.
  • To highlight the importance of expert disagreement in risk assessment for clinical trials.

Main Methods:

  • Discussion of the prominent debate focus in CER justification.
  • Analysis of the shift from "nothing is known" to expert disagreement.
  • Introduction of a case study to illustrate expert disagreement in CER.
  • Framework development for ERC evaluation of expert opinions.

Main Results:

  • The "nothing is known" criterion is potentially misleading for CER evaluation.
  • Expert disagreement is a critical factor in determining the ethical acceptability of CER.
  • ERCs must assess the basis and strength of evidence underlying expert opinions.

Conclusions:

  • ERCs have a duty to evaluate the spectrum of expert opinions to judge study risks.
  • Assessing expert disagreement is crucial for assigning appropriate risk levels to clinical trials.
  • Clinical trial monitoring can mitigate potential risks associated with participant enrollment.