ABSTRACT
Clinical trial simulation (CTS) is a process that mimics clinical trials using computer programs. CTS is particularly important in adaptive designs for several reasons: (1) the statistical theory of adaptive design is complicated with limited analytical solutions available under certain assumptions; (2) the concept of CTS is very intuitive and easy to implement; (3) CTS can be used to model very complicated situations with minimum assumptions, and Type-I error can be strongly controlled; (4) using CTS, we cannot only calculate the power of an adaptive design, but we can also generate many other important operating characteristics such as expected sample-size, conditional power, and repeated confidence interval-ultimately this leads to the selection of an optimal trial design or clinical development plan; (5) CTS can be used to study the validity and robustness of an adaptive design in different hypothetical clinical settings, or with protocol deviations; (6) CTS can be used to monitor trials, project outcomes, anticipate problems, and suggest remedies before it is too late; (7) CTS can be used to visualize the dynamic trial process from patient recruitment, drug distribution, treatment administration, and pharmacokinetic processes to biomarkers and clinical responses; and (8) CTS has minimal cost associated with it and can be done in a short time.
