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Cost-efficient clinical studies with continuous time survival outcomes.

Grecio J Sandoval1, Ionut Bebu1, John M Lachin1

  • 1The Biostatistics Center, Department of Biostatistics and Bioinformatics, The George Washington University, Rockville, Maryland, USA.

Statistics in Medicine
|April 14, 2021
PubMed
Summary

Designing clinical trials with time-to-event outcomes can be costly. This study introduces a framework for cost-efficient clinical trial design, optimizing power while minimizing expected total study costs for better resource allocation.

Keywords:
clinical trial designstudy costtime-to-event outcomes

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Area of Science:

  • Clinical Trial Design
  • Biostatistics
  • Health Economics

Background:

  • Time-to-event outcomes are crucial in clinical studies, particularly in cardiovascular trials.
  • High costs associated with lengthy clinical trials pose significant obstacles.
  • Existing trial design methods often overlook cost considerations.

Purpose of the Study:

  • To develop a general framework for designing cost-efficient clinical trials with time-to-event outcomes.
  • To identify optimal designs that minimize expected total study costs for a given power and type-I error level.
  • To provide a practical tool for researchers to optimize trial resource allocation.

Main Methods:

  • Developed a general framework applicable to Cox proportional hazards and Aalen additive models.
  • Incorporated various recruitment and censoring assumptions.
  • Illustrated the approach using a Weibull time-to-event outcome with uniform recruitment and exponential censoring.
  • Described the application for an additive hazards model.

Main Results:

  • The proposed framework enables the selection of cost-efficient designs that achieve desired statistical power.
  • Identified that various combinations of participants, enrollment, follow-up times, and allocation probabilities can yield the same power.
  • The optimal design minimizes expected total study costs.

Conclusions:

  • A novel framework for cost-efficient clinical trial design with time-to-event outcomes has been presented.
  • The method allows for the optimization of study resources by minimizing expected costs while maintaining statistical rigor.
  • A Shiny web application is available for implementing the proposed methods.