phase12designs
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.
- BOIN12: Bayesian Optimal Interval Phase I/II Trial Design for Utility-Based Dose Finding in Immunotherapy and Targeted Therapies
- BOIN‐ET: Bayesian optimal interval design for dose finding based on both efficacy and toxicity outcomes
- Dose-Finding Based on Efficacy-Toxicity Trade-Offs
- Probability intervals of toxicity and efficacy design for dose-finding clinical trials in oncology
- STEIN: a simple toxicity and efficacy interval design for seamless phase I/II clinical trials
- The Joint i3+3 (Ji3+3) design for phase I/II adoptive cell therapy clinical trials
- Toxicity and Efficacy Probability Interval Design for Phase I Adoptive Cell Therapy Dose-Finding Clinical Trials
- uTPI: a utility-based toxicity probability interval design for phase I/II dose-finding trials
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