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Problems in the conduct and analysis of randomized clinical trials. Are we getting the right answers to the wrong

L Rabeneck1, C M Viscoli, R I Horwitz

  • 1Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06510.

Archives of Internal Medicine
|March 1, 1992
PubMed

Insights

Randomized clinical trials (RCTs) face challenges during conduct, impacting results analysis. New methods are needed to balance trial validity with clinical relevance for accurate therapeutic evaluation.

Area of Science:

  • Clinical Medicine
  • Biostatistics
  • Research Methodology

Background:

  • Randomized clinical trials (RCTs) are the gold standard for evaluating medical therapies.
  • Methodological challenges arise during RCT conduct, affecting result analysis.
  • Key issues include deviations from intended treatment and incomplete outcome ascertainment.

Purpose of the Study:

  • To examine current analytical strategies for handling RCT conduct problems.
  • To assess how these strategies can alter research focus and compromise relevant questions.
  • To advocate for new design and analysis methods ensuring both validity and clinical pertinence.

Main Methods:

  • Review of existing analytical strategies for RCTs.
  • Analysis of how common issues (treatment changes, outcome ascertainment failures) impact trial interpretation.
  • Conceptual framework development for balancing validity and clinical relevance.

Main Results:

  • Current analytic strategies may inadvertently shift research focus away from the primary clinical question.
  • These strategies can lead to trials that are methodologically sound but clinically irrelevant.
  • The identified issues pose significant challenges to the interpretation of therapeutic effectiveness.

Conclusions:

  • Addressing conduct-related problems in RCTs requires innovative analytical approaches.
  • New methods must be developed to maintain the scientific rigor and clinical applicability of trial findings.
  • Balancing validity and clinical pertinence is crucial for advancing evidence-based medicine.
Keywords:
Biomedical and Behavioral Research

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