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Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A

A Nicolucci1, R Grilli, A A Alexanian

  • 1Clinical Epidemiology Unit, Consorzio Mario Negri Sud, S Maria Imbaro (Chieti), Italy.

JAMA
|October 20, 1989
PubMed

Insights

Methodological flaws in lung cancer trials, including handling withdrawals and sample size, hinder progress. Despite some improvements, inconsistent quality and lack of clear efficacy data limit the value of meta-analysis for lung cancer treatment research.

Area of Science:

  • Oncology
  • Clinical Trials Methodology
  • Evidence-Based Medicine

Background:

  • Randomized controlled trials (RCTs) are crucial for advancing lung cancer treatment.
  • Previous reviews suggest methodological limitations in published lung cancer trials.
  • Assessing the quality of evidence is essential for guiding clinical practice and future research.

Purpose of the Study:

  • To critically evaluate the methodological quality of published randomized trials in lung cancer treatment.
  • To identify specific areas of concern in trial design, execution, and reporting.
  • To assess the evolution of trial quality over time and its impact on the reliability of findings.

Main Methods:

  • Systematic review and critical appraisal of 150 published randomized trials on lung cancer treatment.
  • Assessment of methodological aspects including handling of withdrawals, sample size estimation, randomization procedures, and reporting of eligible nonrandomized patients.
  • Analysis of trends in trial quality over time and differences between non-small-cell lung cancer and small-cell lung cancer.

Main Results:

  • Significant methodological drawbacks were identified in the majority of reviewed trials.
  • Key areas of concern included inadequate handling of withdrawals (only 7/150 trials), unspecified sample size calculations (only 9/150), unsatisfactory randomization blinding (only 22/150), and imprecise reporting of eligible nonrandomized patients (only 13/150).
  • While some improvements in design and reporting were observed over time, the evolution was inconsistent, particularly for non-small-cell lung cancer where untreated control arms were abandoned despite lack of proven efficacy.

Conclusions:

  • The methodological quality of lung cancer randomized trials remains a significant concern, limiting the reliability of their findings.
  • Inconsistent trial quality and the abandonment of untreated control arms in non-small-cell lung cancer highlight challenges in establishing effective treatments.
  • The heterogeneity and methodological limitations of existing trials make quantitative meta-analysis unlikely to be constructive for defining optimal lung cancer care.

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