New Book "Bayesian Designs for Phase I-II Clinial Trials" with my colleagues Professor Peter Thall and Dr. Nguyen

(Chapman & Hall/CRC Biostatistics Series)

phase12book

http://www.trialdesign.org

An Integrated Platform for Designing Clinical Trials

 

To facilitate researchers and practitioners to adopt novel adaptive trial designs in practice, we have launched website http://www.trialdesign.org to provide easy-to-use Apps and software for implementing novel phase I, II, I-II clinical trial designs. Our goal is to improve patient care by enhancing the safety, efficiency and success rate of clinical trials through the use of novel adaptive clinical trial designs.

Selected Publications in Peer-reviewed Journals

(* supervised PhD students or postdocs)

[Clinical Trial Design]          [Missing Data]           [Mediation Analysis]

Clinical Trial Design

Tang, R., Shen, J. and Yuan, Y. (2018) ComPAS: A Bayesian Drug-Combination Platform Design with Adaptive Shrinkage, Statistis in Medicine , to appear.

Lin R. and Yuan, Y. (2018) On the Relative Efficiency of Model-Assisted Designs: A Conditional Approach, Journal of Biopharmaceutical Statistics , to appear.

Mu, R.*, Yuan, Y. Xu, J. , Mandrekar, SJ., and Jun Y. (2018) gBOIN: A unified phase I trial design accounting for toxicity grades. Journal of the Royal Statistical Society: Series C , in press

Yan, F., Thall PF, Lu KH, Gilbert MR and Yuan, Y. (2018) Phase I-II clinical trial design: A state-of-the-art paradigm for dose finding. Annals of Oncology , 29, 694-699.

Zhou, H*, Murray, TA, Pan H and Yuan, Y. (2018) Comparative review of novel model-assisted designs for phase I clinical trials. Statistics in Medicine, 37, 2208-2222.

Yuan, Y., Lin, R., Li, D., Nie, L., and Warren K. (2018) Time-to-event Bayesian Optimal Interval Design to Accelerate Phase I Trials. Clinical Cancer Research, 24, 4921-4930.

Zhou, H.*, Yuan, Y. and Nie, L. (2018) Accuracy, Safety and Reliability of Novel Phase I Trial Designs. Clinical Cancer Research, 24, 4357-4364.

Guo, B., Li, D. and Yuan, Y. (2018) SPIRIT: A Seamless Phase I/II Randomized Design for Immunotherapy Trials. Pharmaceutical Statistics, 17, 527-540.

Chu, Y.* and Yuan, Y. (2018) BLAST: Bayesian Latent Subgroup Design for Basket Trials Accounting for Patient Heterogeneity. Journal of the Royal Statistical Society: Series C, 67, 723-740.

Chu, Y.* and Yuan, Y. (2018) A Bayesian Basket Trial Design Using Calibrated Bayesian Hierarchical Model. Clinical Trials, 15, 149-158.

Liu, S., Guo, B. and Yuan, Y. (2018) A Bayesian Phase I/II Design for Immunotherapy Trials. Journal of the American Statistical Association, 113, 1016-1027.

Riviere, M.K., Yuan, Y., Jourdan, J.H., Dubois, F. and Zohar, S. (2018) Phase I/II Dose-Finding Design for Molecularly Targeted Agent: Plateau Determination using Adaptive Randomization. Statistical Methods in Medical Research, 27, 466-479.

Murray, T.*, Yuan, Y., Thall, P., Elizondo, JH. and Hofstetter, WL. (2018) A Bayesian Utility-Based Stratified Medicine Design for the Effectiveness of Nutritional Prehabilitation in Thoracic Surgery. Biometrics, 74, 1095-1103.

Murray, T.*, Yuan, Y. and Thall, P. (2018) A Bayesian Machine Learning Method for Optimizing Dynamic Treatment Regimes. Journal of the American Statistical Association, 113, 1255-1267.

Yan, F., Mandrekar, SJ. and Yuan, Y. (2017) Keyboard: A Novel Bayesian Toxicity Probability Interval Design for Phase I Clinical Trials. Clinical Cancer Research, 23, 3994-4003.

Zhou, H.*, Lee, JJ. and Yuan, Y. (2017) BOP2: Bayesian Optimal Design for Phase II Clinical Trials with Simple and Complex Endpoints. Statistics in Medicine , 36, 3302-3314.

Pan, H.* and Yuan, Y. (2017) A Calibrated Power Prior Approach to Borrow Information from Historical Data with Application to Biosimilar Clinical Trials. Journal of the Royal Statistical Society: Series C , 66, 979-996.

Guo, B.* and Yuan, Y. (2017) Bayesian Phase I/II Biomarker-based Dose Finding for Precision Medicine with Molecularly Targeted Agents. Journal of the American Statistical Association, 112, 508-520.

Murray, T.*, Thall, P., Yuan, Y., McAvoy, S. and Gomez, D. (2017) Robust treatment comparison based on utilities of semi-competing risks in non-small-cell lung cancer. Journal of the American Statistical Association, 112, 11-23.

Zang, Y.* and Yuan, Y. (2017) Optimal Sequential Enrichment Designs for Phase II Clinical Trials. Statistics in Medicine, 36, 54-66.

Yuan, Y., Hess, K., Hilsenbeck, S. and Gilbert, M. (2016) Bayesian Optimal Interval Design: A Simple and Well-Performing Design for Phase I Oncology Trials. Clinical Cancer Research, 22, 4291-430.

Yuan, Y., Guo, B, Munsell, M., Lu, K. and Jazzari, A. (2016) MIDAS: a practical Bayesian design for platform trials with molecularly targeted agents. Statistics in Medicine, 35, 3892-3906.

Zang, Y.*, Liu, S. and Yuan, Y. (2016) Optimal Marker-strategy Clinical Trial Design to Detect Predictive Markers for Targeted Therapy. Biostatistics, 17, 549-560.

Zhang, L.* and Yuan, Y. (2016) A Practical Bayesian Design to Identify the Maximum Tolerated Dose Contour for Drug Combination Trials. Statistics in Medicine, 35, 4924-4936.

Riviere, M.K.*, Yuan, Y., Jourdan, J.H., Dubois, F. and Zohar, S. (2016) Phase I/II Dose-Finding Design for Molecularly Targeted Agent: Plateau Determination using Adaptive Randomization. Statistical Methods in Medical Research, to appear

Chu, Y.*, Pan, H. and Yuan, Y. (2016) Adaptive dose modification for phase I clinical trials. Statistics in Medicine, 35, 3497-508.

Iasonos, A. , Wages N., Conaway, M., Cheung, K., Yuan, Y. and O’Quigley, J. (2016) Dimension of Model Parameter Space and Operating Characteristics in Adaptive Dose-Finding Studies. Statistics in Medicine, 35, 3760-3775.

Pan, H.* and Yuan, Y. (2016) A Default Method to Specify Skeletons for Bayesian Model Averaging Continual Reassessment Method for Phase I Clinical Trials. Statistics in Medicine, 36, 266-279.

Zang, Y.*, J. Lee and Yuan, Y. (2016) Two-stage marker-stratified clinical trial design in the presence of biomarker misclassification. Journal of the Royal Statistical Society: Series C, 65, 585-601.

Guo, B., Li, Y. and Yuan, Y. (2016) A dose-schedule-finding design for phase I/II clinical trials. Journal of the Royal Statistical Society: Series C, 65, 259-272.

Chen, Z., Yuan, Y., Li, Z., Kutner, M., Owonikoko, T., Curran, W, Khuri, F. and Kowalski, J. (2015) Dose escalation with over-dose and under-dose controls in phase I/II clinical trials. Contemporary Clinical Trials, 43, 133-141.

Shen, W.*, Ning, J. and Yuan, Y. (2015) Bayesian sequential monitoring design for clinical trials with non-compliance Statistics in Medicine, 34, 2104-2115.

Zang, Y.*, Liu, S. and Yuan, Y. (2015) Optimal Marker-Adaptive Designs for Targeted Therapy Based on Imperfectly Measured Biomarkers. Journal of the Royal Statistical Society: Series C, 64, 635-650.

Liu, S. and Yuan, Y. (2015) Bayesian Optimal Interval Designs for Phase I Clinical Trials. Journal of the Royal Statistical Society: Series C, 64, 507-523.

Guo, B. and Yuan, Y. (2015) A Bayesian Design for Phase I/II Clinical Trials with Nonignorable Dropout. Statistics in Medicine, 34, 1721-1732.

Shen, W.*, Ning, J. and Yuan, Y. (2015) A Direct Method to Evaluate the Time-dependent Predictive Accuracy for Biomarkers. Biometrics, 71, 439-449.

Liu, S., Pan, H., Huang Q., Xia, J. and Yuan, Y. (2015) Bridging Continual Reassessment Method for Phase I Clinical Trials in Different Ethnic Populations. Statistics in Medicine, 10, 1681-1694.

Riviere, M.K.*, Yuan, Y., Dubois, F. and Zohar, S. (2015) A Bayesian Dose-finding Design for Clinical Trials Combining a Cytotoxic Agent with a Molecularly Targeted Agent. Journal of the Royal Statistical Society: Series C, 64, 215-229.

Jin, I.H.*, Liu, S., Thall, P. and Yuan, Y. (2014) Using Data Augmentation to Facilitate Conduct of Phase I/II Clinical Trials with Delayed Outcomes. Journal of the American Statistical Association, 109, 525-536.

Riviere M.K., Yuan Y. , Dubois F. and Zohar S. (2014) A Bayesian dose-finding design for drug combination clinical trials based on the logistic model. Pharmaceutial Statistics, 13, 247-257.

Zang, Y.*, Lee J. and Yuan, Y. (2014) Adaptive designs for identifying optimal biological dose for molecularly targeted agents. Clinical Trials, 11, 319-327.

Cai, C.*, Liu, S. and Yuan, Y. (2014) A Bayesian Design for Phase II Clinical Trials with Delayed Responses Based on Multiple Imputation. Statistics in Medicine, 33, 4017-4028.

Liu, S., Yuan, Y. , Castillo, R., Guerrero, T. and Johnson, V.E. (2014) Evaluation of Deformable Image Registration Spatial Accuracy Using a Bayesian Hierarchical Model. Biometrics, 70, 366-377.

Cai, C.*, Yuan, Y. and Ji, Y. (2014) A Bayesian Phase I/II Design for Oncology Clinical Trials of Combining Biological Agents. Journal of the Royal Statistical Society: Series C, 63, 159-173.

Liu, S., Yin, G. and Yuan, Y. (2013) Bayesian Data Augmentation Dose Finding with Continual Reassessment Method and Delayed Toxicity. Annals of Applied Statistics, 4, 2138-2156.

Ahn, J.*, Yuan, Y., Parmigiani, G., Suraokar, M. B., Diao, L., Wistuba, I. and Wang W. (2013) DeMix: Deconvolution for mixed cancer transcriptomes using raw measured data. Bioinformatics, 29, 1865-1871.

Cai, C.*, Yuan, Y. and Johnson, V.E. (2013) Bayesian adaptive phase II screening design for combination trials. Clinical Trials, 10, 353-362.

Jin, I.H.*, Yuan, Y. and Liang, F. (2013) Bayesian analysis for exponential random graph models using the adaptive exchange sampler. Statistics and Its Interface, 6, 559-576.

Zang, Y*. and Yuan, Y. (2013) A Shrinkage Method for Testing the Hardy-Weinberg Equilibrium in Case-Control Studies. Genetic Epidemiology, 37, 743-750.

Yuan, Y., Thall, P. andWolf, J. (2012) Estimating Progression-free Survival When the Progression Status of Some Subjects is Unknown. Journal of the Royal Statistical Society: Series C, 61, 135-149.

Yuan, Y. and Johnson, V.E. (2012) Goodness-of-Fit Diagnostics for Bayesian Hierarchical Models. Biometrics 68, 156-164.

Huo, L.*, Yuan, Y. and Yin, G. (2012) Dose Finding in Drug Combinations with Discrete and Continuous Doses. Bayesian Analysis, 7, 235-252.

Yuan, Y. and Yin, G. (2011) Robust EM Continual Reassessment Method in Oncology Dose Finding. Journal of the American Statistical Association 106, 818-831. (featured article)

Lei, X., Yuan, Y. and Yin, G. (2011) Bayesian phase II adaptive randomization by jointly modeling time-to-event efficacy and binary toxicity. Lifetime Data Analysis 17, 156-174.

Yuan, Y. and Yin, G. (2011) Bayesian phase I/II drug-combination trial design in oncology. Annals of Applied Statistics, 5, 924-942.

Yuan, Y. and Yin, G. (2011) Bayesian Hybrid Design in Phase I Oncology Clinical Trials. Statistics in Medicine, 30, 2098-2108.

Yuan, Y., Huang, X. and Liu, S. (2011) A Bayesian response-adaptive covariate-balanced randomization design for clinical trials. Statistics in Medicine, 30, 1218-1229.

Yuan, Y. and Yin, G. (2011) On adaptive randomization: is it useful? Journal of Clinical Oncology, 29, e390-e392

Yin, G., Ma, Y., Liang, F. and Yuan, Y. (2011) Stochastic generalized method of moments. Journal of Computational and Graphical Statistics 20, 714-727.

Yuan, Y. and Yin, G. (2011) Dose-response curve estimation: A semiparametric mixture approach. Biometrics 67, 1543-1554.

Yin, G. and Yuan, Y. (2009) Bayesian Model Averaging Continual Reassessment Method in Phase I Clinical Trials. Journal of the American Statistical Association 104, 954-968.

Song P.X., Li, M. and Yuan, Y. (2009) Joint Regression Analysis of Correlated Data Using Gaussian Copulas. Biometrics 65, 60-68.

Yin, G. and Yuan, Y. (2009) A latent contingency table approach to dose-finding for combinations of two agents. Biometrics 65, 866-875.

Yin, G. and Yuan, Y. (2009) Bayesian Dose-finding in Oncology for Drug Combinations by Copula Regression. Journal of the Royal Statistical Society: Series C 58, 211-224.

Yuan, Y. and Yin, G. (2009) Bayesian Dose-finding by Jointly Modeling Toxicity and Efficacy as Time-to-Event Outcomes. Journal of the Royal Statistical Society: Series C 58, 719-736.

Yuan, Y. and Johnson, V.E. (2008) Bayesian Hypothesis Tests Using Nonparametric Statistics. Statistica Sinica 18, 1185-1200

Yuan, Y. and Yin, G. (2008) Sequential Continual Reassessment Method for Two-dimensional Dose Finding. Statistics in Medicine 27, 5664-5678.

Missing Data Analysis

Ahn, J.*, Liu, S., Wang W. and Yuan, Y. (2013) Bayesian Latent-class Mixed-effect Hybrid Models for Dyadic Longitudinal Data with Non-ignorable Dropouts. Biometrics, 69, 914-924.

Zhang G. and Yuan, Y. (2012) Modeling Longitudinal Dyadic Data with Nonignorable Dropout with Application to a Breast Cancer Study. Annals of Applied Statistics, 6, 753-771.

Yuan, Y. and Yin, G. (2010). Quantile regression for longitudinal studies with nonignorable missing data. Biometrics, 66, 105-114.

Yuan, Y. and Little, R.J.A. (2009) Meta-analysis of studies with missing data. Biometrics 65, 487-496.

Yuan, Y. and Little, R.J.A. (2009) Mixed-effect hybrid models for longitudinal data with nonignorable dropout. Biometrics 65, 478-486.

Yuan, Y., and Little, R.J.A. (2007) Model-Based Estimates of the Finite Population Mean for Two-Stage Cluster Samples with Unit Non-response. Journal of the Royal Statistical Society: Series C 56, 79-97.

Yuan, Y., and Little, R.J.A. (2007) Parametric and Semiparametric Model-based Estimates of the Finite Population Mean for Two-Stage Cluster Samples with Item Nonresponse. Biometrics 63, 1172-1180.

Mediation Analysis

Huang J., Yuan, Y. and Wetter D. (2018) Latent Class Dynamic Mediation Model with Application to Smoking Cessation Data, Psychometrika, 22(4):667-686.

Huang, J.* and Yuan, Y. (2017) Bayesian Dynamic Mediation Analysis, Psychological Methods, to appear.

Yuan, Y. and MacKinnon D. (2014) Robust mediation analysis based on mediation regression. Psychological Methods, 19, 1-20.

Yuan, Y. and MacKinnon D. (2009) Bayesian mediation analysis. Psychological Methods, 14, 301-322.

More Publications