Software

• Designing and conducting single-agent phase I trials using the isotonic method of Conaway, Dunbar, and Peddada (2004)

• Designing and conducting single-agent phase I trials using the Bayesian continual reassessment method (CRM)

• Evaluating phase I methods using a non-parametric optimal benchmark

• Designing and conducting single-agent phase I/II trials using the method of Wages and Tait (2015)

• Designing and conducting combination phase I trials using partial order continual reassessment method (PO-CRM)

• Designing and conducting phase I trials using the patient-reported outcomes continual reassessment method

An R package pocrm containing functions for the implementation and simulation of the continual reassessment method for partial ordering (POCRM) for use in phase I clinical trials of combinations of agents can be downloaded from the Comprehensive R Archive Network (CRAN). For Windows, the pocrm library can be downloaded from within R GUI by clicking on Packages/Install package(s), choose a mirror site, and locating pocrm. Questions regarding the R code, the literature, and the application of POCRM are welcome and should be sent here.

• Horton, Wages, Gentzler (2021+) design.
• Patient-reported outcomes continual reassessment method (PRO-CRM)
• Dose-finding in a dynamic set of drug combinations.
• Adaptive dose finding based on safety and feasibility in early-phase clinical trials of adoptive cell immunotherapy.
• Coherence principles in interval-based dose-finding.
• Efficient dose-finding for drug combination studies involving a shift in study populations (Breast 49).
• Flexible phase I-II design for partially ordered regimens.
• Calculation of least informative prior variance in the Bayesian CRM.
• Designing and conducting single-agent phase I trials using the Bayesian continual reassessment method
• O’Quigley J, Paoletti X, Maccario J. Non-parametric optimal design in dose-finding studies. Biostatistics (2002); 3: 51-56.
• Zohar S, O’Quigley J. Optimal designs for estimating the most successful dose.  Stat Med (2006); 25: 4311-4320.