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Blinded sample size re-estimation for recurrent event data with time trends.

S Schneider1, H Schmidli, T Friede

  • 1Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.

Statistics in Medicine
|October 10, 2013
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Summary
This summary is machine-generated.

This study introduces a new method for blinded sample size re-estimation (BSSR) for recurrent event data with time trends, improving accuracy in clinical trials for diseases like multiple sclerosis.

Keywords:
adaptive designblinded sample size re-estimationclinical trialsevent countssample size

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Epidemiology

Background:

  • Traditional fixed sample size designs have limitations in managing uncertainty.
  • Existing blinded sample size re-estimation (BSSR) methods for recurrent events assume constant event rates, which is often unrealistic.
  • Relapsing multiple sclerosis studies often exhibit time trends in event rates.

Purpose of the Study:

  • To propose and evaluate methods for BSSR in recurrent event data when event rates have a time trend.
  • To address limitations of current BSSR approaches in complex clinical scenarios.
  • To ensure robust sample size planning and accurate final analysis in clinical trials.

Main Methods:

  • Development of BSSR methods based on a proportional intensity frailty model to account for time trends.
  • Utilizing standard negative binomial methods for initial sample size planning and final analysis.
  • Employing a full likelihood analysis for interim sample size re-estimation.
  • Conducting a simulation study motivated by relapsing multiple sclerosis data.

Main Results:

  • The proposed BSSR procedure effectively controls the type I error rate.
  • The method maintains desired statistical power even with misspecified nuisance parameters.
  • Study duration and recruitment period length significantly impact operating characteristics.
  • The approach is suitable when patient follow-up time is balanced across treatment groups.

Conclusions:

  • The proposed BSSR methods offer a more accurate approach for sample size determination in recurrent event studies with time trends.
  • This methodology enhances the reliability of clinical trial results, particularly in diseases like multiple sclerosis.
  • The findings provide valuable guidance for optimizing clinical trial design and statistical analysis.