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Sample size determination in clinical trials with an emphasis on exponentially distributed responses
A J Gross1, H H Hunt, A B Cantor
1Department of Biometry, Medical University of South Carolina, Charleston 29425.
Biometrics
|December 1, 1987
Summary
Determining clinical trial sample size requires balancing factors like patient survival, error rates, and trial length. This study optimizes trial and recruitment periods to minimize expected costs, using assumed patient entry and exponential survival distributions.
Area of Science:
- Biostatistics
- Clinical Trial Design
- Epidemiology
Background:
- Sample size determination in clinical trials is influenced by patient survival distributions, parameter estimates under null and alternative hypotheses, and Type I/II error rates.
- Clinical trial length impacts the number of censored survival observations.
- Patient recruitment period, shorter than trial length, is a critical factor in study planning.
Purpose of the Study:
- To explore optimal lengths for clinical trials and patient recruitment periods.
- To minimize the overall expected cost of conducting clinical trials.
Main Methods:
- Utilized a specified cost function for analysis.
- Assumed a patient entry distribution.
- Employed an exponential survival distribution for illustrative purposes.
Main Results:
- Identified optimal clinical trial and recruitment period lengths based on cost minimization.
- Demonstrated the impact of these lengths on study efficiency and resource allocation.
Conclusions:
- Optimizing clinical trial and recruitment periods can lead to significant cost savings.
- The findings provide a framework for more efficient clinical trial planning and resource management.