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The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization.

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Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|January 23, 2016
PubMed
Summary
This summary is machine-generated.

The efficacy-effectiveness gap (EEG) challenges drug decision-making. Understanding EEG paradigms, particularly the interaction between drug effects and context, can improve clinical trial design for better real-world effectiveness estimates.

Keywords:
efficacy-effectiveness gapoutcomes researchpharmaceuticalspragmatic clinical trials

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Area of Science:

  • Pharmacoeconomics and Health Technology Assessment
  • Clinical Trial Design and Methodology
  • Evidence-Based Medicine

Background:

  • The "efficacy-effectiveness gap" (EEG) concept questions reliance on randomized controlled trials (RCTs) alone for drug approval.
  • The GetReal project, funded by the Innovative Medicines Initiative, seeks to bridge this gap by reconciling efficacy and effectiveness evidence.

Purpose of the Study:

  • To explore the historical emergence of the EEG concept.
  • To delineate the conceptualization of the EEG.

Main Methods:

  • A focused literature review of gray and published English literature on the EEG concept.
  • Inductive analysis of document content to identify distinct "paradigms" of the EEG.

Main Results:

  • The literature on EEG is categorized into three main paradigms.
  • These paradigms relate EEG to healthcare system characteristics, measurement methods, or the interplay between drug effects and context.

Conclusions:

  • The third paradigm, emphasizing drug-biological effect and contextual factors, offers a nuanced perspective beyond "standardized" vs. "real-life" dichotomies.
  • Future research should investigate how identifying contextual factors can optimize RCT design for improved drug effectiveness estimation.