General Early-Phase Trial Design

• Wages NA, Horton BJ, Conaway MR, et al. Operating characteristics are needed to properly evaluate the scientific validity of phase I protocols. Contemp Clin Trials 2021; 108: 106517. 
• Wages NA, Iasonos A, O'Quigley J, et al. Coherence principles in interval-based dose-finding. Pharm Stat 2020; 19: 137-144.
• Wages NA, Bagley E. Evaluation of irrational dose assignment definitions using the continual reassessment method. Clin Trials 2019; 16: 665-672.
• Hobbs B, Barata P, Kanjanapan Y, et al. Seamless designs: current practice and considerations for early phase drug development in oncology. J Natl Cancer Inst 2019; 11: 118-128.
• Wages NA, Yuan Y. Preface to the themed issue on 'Early phase clinical trial design methodology.' J R Stat Soc Ser C Appl Stat 2019; 68: 267-269.

• Wages NA, Braun TM. Accuracy, safety, and reliability of novel phase I designs - letter. Clin Cancer Res 2018; 24: 5482.

• Wages NA, Conaway MR. Revisiting isotonic phase I design in the era of model-assisted dose-finding. Clin Trials 2018; 15: 524-529.

• Wages NA, Petroni GR. A web tool for designing and conducting phase I trials using the continual reassessment method. BMC Cancer 2018; 18:133.

• Wages NA, Varhegyi N. A web application for evaluating phase I methods using a non-parametric optimal benchmark. Clin Trials  2017; 14: 553-557.

• Horton BJ, Wages NA, Conaway MR. Performance of toxicity probability interval based designs in contrast to the continual reassessment method. Stat Med 2017; 36: 291-300.

• Petroni GR, Wages NA, Paux G, et al. Implementation of adaptive methods in early-phase clinical trials. Stat Med 2017; 36: 215-224.

• Iasonos A, Wages NA, Conaway MR, et al. Dimension of model parameter space and operating characteristics in adaptive dose-finding studies. Stat Med 2016; 35: 3760-3775.

• Wages NA, Conaway MR, O'Quigley J. Performance of two-stage continual reassessment method relative to an optimal benchmark. Clin Trials 2013; 10: 862-75.

Patient Heterogeneity

• Wages NA, Millard TA, Dillon PM, et al. Efficient dose-finding for drug combination studies involving a shift in study populations. Contemp Clin Trials Commun 2020; 17: 100519.

• Horton BJ, Wages NA, Conaway MR. Shift models for dose finding in partially ordered groups. Clin Trials 2019; 16: 32-40.

• Conaway MR, Wages NA. Designs for phase I trials in ordered groups. Stat Med 2017; 36: 254-265.

• Wages NA, Read PW, Petroni GR. A phase I/II adaptive design for heterogeneous groups with application to a stereotactic body radiation trial. Pharm Stat 2015; 14: 302-310.

Immunotherapies & Targeted Agents

• Wages NA, Slingluff CL, Bullock TN, et al. Tailoring early-phase clinical trial design to address multiple research objectives. Cancer Immunol Immunother 2020; 69: 95-102.

• Wages NA, Fadul CE. Adaptive dose finding based on safety and feasibility in early-phase clinical trials of adoptive cell immunotherapy. Clin Trials 2020; 17: 157-165.

• Wages NA, Slingluff CL. Flexible phase I-II design for partially ordered regimens with application to therapeutic cancer vaccines. Stat Biosci 2020; 12: 104-123.

• Yan D, Tait C, Wages NA, et al. Generalization of the time-to-event continual reassessment method to bivariate outcomes. J Biopharm Stat 2019; 29: 635-647.
• Yan D, Wages NA, Dressler EV. Improved adaptive randomization strategies for a seamless phase I/II dose-finding design. J Biopharm Stat 2019 29: 333-347.
• Wages NA, Chiuzan C, Panageas KS. Design considerations for early-phase clinical trials of immune-oncology agents. J Immunother Cancer 2018; 6: 81.
• Wages NA, Portell CA, Williams ME, et al. Implementation of a model-based design in a phase 1b study of combined targeted agents. Clin Cancer Res 2017; 23: 7158-7164. R CODE
• Wages NA, Slingluff CL, Petroni GR. Statistical controversies in clinical research: early-phase adaptive design for combination immunotherapies. Ann Oncol 2017; 28: 696-701. R CODE

• Wages NA, Slingluff CL, Petroni GR. A phase I/II adaptive design to determine the optimal treatment regimen from a set of combination immunotherapies in high-risk melanoma. Contemp Clin Trials 2015; 41: 172-179.

• Wages NA, Tait C. Seamless phase I/II adaptive design for oncology trials of molecularly targeted agents. J Biopharm Stat 2015; 25: 903-920.

Drug Combinations

• Clertant M, Wages NA, O'Quigley J. Semi-parametric dose finding methods for partially ordered drug combination trials. Stat Sin 2021; [epub ahead of print] March 18. 
• Wages NA, Reed DR, Keng MK, Conaway MR, Petroni GR. Adapting isotonic dose-finding to a dynamic set of drug combinations with application to a phase I leukemia trial. Clin Trials 2021; [epub ahead of print] Jan 11. 
• Wages NA. Identifying a maximum tolerated contour in two-dimensional dose-finding. Stat Med 2017; 36: 215-224. R CODE.
• Wages NA, Ivanova A, Marchenko O. Practical designs for phase I combination studies in oncology. J Biopharm Stat 2016; 26: 150-166.
• Hirakawa A, Wages NA, Sato H, et al. A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies. Stat Med 2015; 34: 3194-3213.

• Wages NA, Conaway MR, Slingluff CL, et al. Recent developments in the implementation of novel designs for early-phase combination studies. Ann Oncol 2015; 26: 1036-1037.

• Wages NA, Conaway MR. Phase I/II adaptive design for drug combination oncology trials. Stat Med 2014; 33: 1990-2003. R CODE

• Wages NA, Varhegyi N. pocrm: An R package for Phase I trials of combinations of agents. Comput Methods Programs Biomed 2013; 112: 211-218.

• Wages NA, Conaway MR. Specifications of a continual reassessment method design for phase I trials of combined drugs. Pharm Stat 2013; 12: 217-224.

• Wages NA, Conaway MR, O'Quigley J. Using the time-to-event continual reassessment method in the presence of partial orders. Stat Med 2013, 32: 131-141. R CODE

• Wages NA, Conaway MR, O'Quigley J. Continual reassessment method for partial ordering. Biometrics 2011; 67: 1555-1563. R CODE

• Wages NA, Conaway MR, O'Quigley J. Dose-finding design for multi-drug combinations. Clin Trials 2011; 8: 380-389. R CODE

Multiple treatment schedules

• Wages NA, O'Quigley J, Conaway MR. Phase I design for completely or partially ordered treatment schedules. Stat Med 2014; 33: 569-579. R CODE