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Related Experiment Video

Updated: Feb 21, 2026

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A simulation study comparing backfill and randomized expansion in oncology dose optimization.

Huan Cheng1, Xiaoyun Nicole Li1

  • 1Global Statistics and Data Science, BeOne Medicines, San Carlos, USA.

Journal of Biopharmaceutical Statistics
|February 19, 2026
PubMed
Summary

The one-stage backfill design can reduce study time and sample size for dose optimization compared to two-stage expansion designs in homogeneous settings. Futility monitoring enhances efficiency, but backfill designs are sensitive to heterogeneity.

Keywords:
Oncologybackfilldose findingdose optimizationmaximum tolerated doseoptimal dose selectionrandomized expansion

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Area of Science:

  • Clinical Trial Design
  • Biostatistics
  • Pharmacometrics

Background:

  • Dose optimization is crucial for drug development.
  • Two common designs are two-stage expansion and one-stage backfill.
  • Limited comparative studies exist for these designs.

Purpose of the Study:

  • To compare the performance of two-stage expansion and one-stage backfill designs.
  • To evaluate dose selection methods under various scenarios.
  • To assess the impact of futility monitoring and patient exclusion in backfill designs.

Main Methods:

  • Comprehensive simulation studies were conducted.
  • Compared rule-based, utility-based, and model-based dose selection methods.
  • Evaluated designs with and without imbalance factors and futility monitoring.

Main Results:

  • Backfill designs can shorten study duration and reduce sample size in homogeneous settings.
  • Futility monitoring improves efficiency with minimal power loss.
  • Backfill designs are more sensitive to delayed efficacy or heterogeneity.

Conclusions:

  • One-stage backfill design is efficient for homogeneous populations.
  • Two-stage expansion design offers greater robustness in heterogeneous settings.
  • Design choice depends on population characteristics and study goals.