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Improving sample size recalculation in adaptive clinical trials by resampling.

Carolin Herrmann1, Corinna Kluge1, Maximilian Pilz2

  • 1Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, 10117 Berlin, Germany.

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Summary
This summary is machine-generated.

Adaptive clinical trial designs can be improved by resampling interim data. This method reduces sample size variability and enhances study performance, offering a more robust approach to sample size recalculation.

Keywords:
adaptive group sequential designclinical trialresamplingsample size recalculation

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Methods

Background:

  • Accurate sample size is crucial in clinical trials to avoid ethical and economic issues.
  • Adaptive group sequential designs allow for sample size updates during trials based on interim results.

Purpose of the Study:

  • To investigate the impact of resampling the interim test statistic on sample size recalculation in clinical trials.
  • To evaluate the performance improvement of resampling-based sample size recalculation methods.

Main Methods:

  • Focus on clinical trials with normally distributed endpoints.
  • Applied resampling of the observed interim test statistic to established sample size recalculation methods.
  • Analyzed the smoothness and variability of sample size recalculation rules.

Main Results:

  • Resampling approaches lead to smoother recalculation rules and lower sample size variability.
  • Certain resampling methods were found to mimic group sequential designs.
  • Incorporating resampling significantly improved the performance of existing recalculation rules.

Conclusions:

  • Resampling the interim test statistic is a valuable strategy for enhancing sample size recalculation in adaptive clinical trials.
  • This approach offers substantial performance improvements and reduces uncertainty in sample size planning.
  • The findings support the integration of resampling techniques for more efficient and reliable clinical trial design.