General Early-Phase Trial Design
- 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.
- Conaway MR, Petroni GR. The impact of early phase trial design in the drug development process. Clin Cancer Res 2019; 25: 819-827.
- 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.
- O’Quigley J, Conaway MR. Extended model-based designs for more complex dose-finding studies. Stat Med 2011; 30: 2062-2069.
- O’Quigley J, Conaway MR. Continual reassessment and related dose-finding designs. Stat Sci 2010; 25: 202-216.
- Horton BJ, O’Quigley J, Conaway MR. Consequences of performing parallel dose finding trials in heterogeneous groups of patients. JNCI Cancer Spectr 2019; 3: pkz013.
- Horton BJ, Wages NA, Conaway MR. Shift models for dose finding in partially ordered groups. Clin Trials 2019; 16: 32-40.
- Conaway MR. Isotonic designs for phase I trials in partially ordered groups. Clin Trials 2017; 14: 491-498.
- Conaway MR. A design for phase I trials in completely or partially ordered groups. Stat Med 2017; 36: 2323-2332.
- 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.
- 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.
- 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