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CRANescalationMaRDI QIDQ133814FDOQ133814
A Modular Approach to Dose-Finding Clinical Trials
Michael Sweeting, Daniel Slade, Kristian Brock
Last update: 23 February 2024
Copyright license: GNU General Public License
Software version identifier: 0.1.4, 0.1.5, 0.1.1, 0.1.2, 0.1.3, 0.1.8
Methods for working with dose-finding clinical trials. We provide implementations of many dose-finding clinical trial designs, including the continual reassessment method (CRM) by O'Quigley et al. (1990) <doi:10.2307/2531628>, the toxicity probability interval (TPI) design by Ji et al. (2007) <doi:10.1177/1740774507079442>, the modified TPI (mTPI) design by Ji et al. (2010) <doi:10.1177/1740774510382799>, the Bayesian optimal interval design (BOIN) by Liu & Yuan (2015) <doi:10.1111/rssc.12089>, EffTox by Thall & Cook (2004) <doi:10.1111/j.0006-341X.2004.00218.x>; the design of Wages & Tait (2015) <doi:10.1080/10543406.2014.920873>, and the 3+3 described by Korn et al. (1994) <doi:10.1002/sim.4780131802>. All designs are implemented with a common interface. We also offer optional additional classes to tailor the behaviour of all designs, including avoiding skipping doses, stopping after n patients have been treated at the recommended dose, stopping when a toxicity condition is met, or demanding that n patients are treated before stopping is allowed. By daisy-chaining together these classes using the pipe operator from 'magrittr', it is simple to tailor the behaviour of a dose-finding design so it behaves how the trialist wants. Having provided a flexible interface for specifying designs, we then provide functions to run simulations and calculate dose-paths for future cohorts of patients.
- Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer
- Dose-Finding Based on Efficacy-Toxicity Trade-Offs
- Dose-finding in phase I clinical trials based on toxicity probability intervals
- A modified toxicity probability interval method for dose-finding trials
- Bayesian optimal interval designs for phase I clinical trials
- Seamless Phase I/II Adaptive Design for Oncology Trials of Molecularly Targeted Agents
- A comparison of two phase I trial designs
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