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Related Experiment Videos

Sample size calculation for complex clinical trials with survival endpoints

J H Shih1

  • 1Office of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland 20892- 7938, USA.

Controlled Clinical Trials
|December 1, 1995
PubMed
Summary
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This study introduces SIZE, a computer program designed to calculate sample size, power, and study duration for clinical trials. It addresses complex factors like time-dependent events and treatment uncertainties, aiding in robust trial planning.

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Medical Informatics

Background:

  • Accurate sample size estimation is critical for the successful planning and execution of clinical trials.
  • Traditional methods may not adequately address the complexities inherent in many modern clinical trial designs.
  • The need for specialized software to handle advanced statistical considerations in trial planning is evident.

Purpose of the Study:

  • To introduce and describe the features and utility of the SIZE computer program.
  • To demonstrate the program's capability in calculating sample size, power, and study duration for clinical trials.
  • To highlight the program's application in trials with time-dependent event rates, crossover, and loss to follow-up.

Main Methods:

  • The study focuses on the description and application of the SIZE computer program.

Related Experiment Videos

  • The program is designed to handle complex clinical trial scenarios, including nonproportional hazards and lag in treatment effects.
  • Illustrative examples using hypothetical and real study designs are employed to showcase the program's functionality.

    • Main Results:

    • The SIZE program provides a comprehensive tool for sample size, power, and duration calculations in clinical trials.
    • It effectively accommodates complexities such as time-dependent event rates, crossover, and loss to follow-up.
    • The program addresses advanced statistical issues including nonproportional hazards and uncertainties in treatment benefit.

    Conclusions:

    • The SIZE program is a valuable resource for researchers designing clinical trials with complex statistical considerations.
    • Its comprehensive features facilitate accurate planning, enhancing the reliability and efficiency of clinical studies.
    • The program's ability to model various trial complexities aids in overcoming common statistical challenges in trial design.