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Extrapolating Survival from Randomized Trials Using External Data: A Review of Methods.

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Summary

This study presents methods for health economic models to estimate long-term survival by combining trial data with external sources. It categorizes approaches based on assumptions for extrapolating survival trends and population differences.

Keywords:
detailed methodologyinternal medicinemultiparameter evidence synthesissurvival analysistechnology assessment

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Area of Science:

  • Health Economics
  • Biostatistics
  • Epidemiology

Background:

  • Health economic models require accurate long-term survival estimates for cost-effectiveness analyses.
  • Short-term data from randomized controlled trials (RCTs) often necessitates extrapolation for long-term predictions.
  • External data sources can supplement RCT data for improved survival modeling.

Purpose of the Study:

  • To describe and categorize methods for estimating long-term survival parameters in health economic models.
  • To evaluate approaches that combine individual-level survival data from RCTs with external data for extrapolation.
  • To discuss the assumptions, modeling choices, and uncertainty characterization in survival data extrapolation.

Main Methods:

  • Systematic search of study reports from a UK health technology assessment program.
  • Conducted "pearl-growing" searches of the academic literature.
  • Categorized methods based on assumptions regarding hazard variation between internal (trial) and external data, and over time.

Main Results:

  • Identified and categorized various methods for combining short-term trial survival data with longer-term external data.
  • Highlighted the critical role of assumptions about post-trial survival trends and population differences.
  • Discussed the appropriateness of different assumptions in various contexts.

Conclusions:

  • The choice of methods and underlying assumptions significantly impacts the reliability of long-term survival estimates in health economic models.
  • Further research is needed to refine methods for parameter estimation and uncertainty characterization in survival extrapolation.
  • Appropriate use of external data and clear articulation of assumptions are crucial for robust health economic evaluations.