phase12designs: Comprehensive Tools for Running Model-Assisted Phase I/II Trial Simulations

Provides a comprehensive set of tools to simulate, evaluate, and compare model-assisted designs for early-phase (Phase I/II) clinical trials, including: - BOIN12 (Bayesian optimal interval phase 1/11 trial design; Lin et al. (2020) <doi:10.1200/PO.20.00257>), - BOIN-ET (Takeda, K., Taguri, M., & Morita, S. (2018) <doi:10.1002/pst.1864>), - EffTox (Thall, P. F., & Cook, J. D. (2004) <doi:10.1111/j.0006-341X.2004.00218.x>), - Ji3+3 (Joint i3+3 design; Lin, X., & Ji, Y. (2020) <doi:10.1080/10543406.2020.1818250>), - PRINTE (probability intervals of toxicity and efficacy design; Lin, X., & Ji, Y. (2021) <doi:10.1177/0962280220977009>), - STEIN (simple toxicity and efficacy interval design; Lin, R., & Yin, G. (2017) <doi:10.1002/sim.7428>), - TEPI (toxicity and efficacy probability interval design; Li, D. H., Whitmore, J. B., Guo, W., & Ji, Y. (2017) <doi:10.1158/1078-0432.CCR-16-1125>), - uTPI (utility-based toxicity Probability interval design; Shi, H., Lin, R., & Lin, X. (2024) <doi:10.1002/sim.8922>). Includes flexible simulation parameters that allow researchers to efficiently compute operating characteristics under various fixed and random trial scenarios and export the results.

install.packages("phase12designs")

Try the phase12designs package in your browser