Cost-Effectiveness Analysis (CEA) has become an increasingly important component of clinical trials. However, formal sample size calculations for such studies are not common. One of the reasons for this might be due to the absence of readily available computer software to perform complex calculations, particularly in a Bayesian setting. In this paper, a C++ program (using NAG library functions/subroutines) is presented to estimate the sample sizes for cost-effectiveness clinical trials in a Bayesian framework. The program can equally be used to calculate sample sizes for efficacy trials. The Bayesian approach to sample size calculation is based on that of O'Hagan and Stevens (A. O'Hagan, J.W. Stevens, Bayesian assessment of sample size for clinical trials of cost-effectiveness, Medical Decision Making 21 (2001) 219-230). With this program, the user can calculate sample sizes for various thresholds of willingness to pay and under various assumptions of the correlations between cost and effects. Under some prior, the program produces frequentist sample size as well. The program runs under windows environment and running time is very short.
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