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A sample size program for "proving the null hypothesis".

C Heiselbetz, L Edler

Controlled Clinical Trials

|March 1, 1987

Summary

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This study introduces a flexible APL computer program to aid in planning clinical trials for testing therapy equivalence. The program calculates key trial characteristics, offering an alternative to traditional sample size graphs.

Area of Science:

Biostatistics
Clinical Trial Design
Health Informatics

Background:

Clinical trials are essential for evaluating new therapies.
Accurate sample size calculation is critical for trial validity and efficiency.
Existing methods like Blackwelder and Chang graphs have limitations.

Purpose of the Study:

To present a flexible APL computer program for clinical trial planning.
To provide a computational alternative to traditional sample size graphs.
To facilitate the calculation of essential trial design parameters.

Main Methods:

Development of a flexible APL (A Programming Language) computer program.
Implementation of algorithms to calculate six key trial characteristics.

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User-defined input for five parameters to determine the sixth.

Main Results:

The program successfully calculates sample size, significance level, power, and probabilities.
It allows for the determination of the minimum difference of interest.
Offers a versatile tool for trial planning, replacing static graphs.

Conclusions:

The APL program offers a flexible and powerful tool for clinical trial design.
It enhances the planning process by providing accurate calculations for equivalence trials.
This computational approach improves upon existing graphical methods for sample size determination.