Abstract
Most phase II cancer trials evaluate total response (TR) rate using a single-arm open-label design. Simon's two-stage design minimizes either the expected or the total number of patients. In this article, we investigate the distribution of time to reaching trial conclusion (TRTC) of such two-stage trials, which considers the accrual rate, time to TR, futility, and efficacy decision rules. We develop a Monte Carlo algorithm for the distribution of TRTC for both one- and two-stage phase II designs. We further propose an optimal design that balances the needs of concluding the trial within the required time period and minimizing the expected sample size. Generalized recursive formulas are derived analytically in the Appendix, which are theoretically interesting but not recommended for practical use. In conclusion, a consideration of the TRTC can lead to an optimal design with a minimum increase in the expected number of patients but an increased confidence in reaching study conclusions within the required time.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.