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Stopping a trial early in oncology: for patients or for industry?

F Trotta1, G Apolone2, S Garattini2

  • 1Italian Medicines Agency (AIFA), Rome.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|February 29, 2008
PubMed
Abstract

Insights

Early stopping of cancer drug trials via interim analyses spares patients but raises concerns about evidence quality. Untruncated trials offer more reliable data for clinical practice.

Area of Science:

  • Oncology
  • Clinical Trials
  • Biostatistics

Background:

  • Assessing the utilization of interim analyses in randomized controlled trials (RCTs) for novel anticancer drug development.
  • Focusing on oncological clinical trials that were terminated early due to demonstrated benefit.

Purpose of the Study:

  • To evaluate the practice and implications of early stopping in cancer clinical trials based on interim analysis results.
  • To investigate the quality of evidence generated from early-terminated oncological trials.

Main Methods:

  • Systematic review of published clinical trials stopped early for benefit over the last 11 years.
  • Inclusion criteria: anticancer drugs, randomized controlled trials, and presence of an interim analysis.

Main Results:

  • Analyzed 25 RCTs; over 40% used overall survival as a time-related primary endpoint.
  • Efficacy evaluation at interim analysis consistently used the planned final analysis endpoint (95% of studies).
  • Early termination spared approximately 3300 patients/events; 78% of recent trials were used for drug registration.

Conclusions:

  • While early stopping spares patients and resources, it raises concerns about the completeness of evidence.
  • The drive for early termination may be influenced by market and cost considerations.
  • Uninterrupted trials provide a higher level of evidence for reliable clinical translation.

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