Lanju Zhang

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All published works

Action	Title	Year	Authors
+	Clinical Trial Design and Analysis Considerations for Rare Diseases	2023	Lanju Zhang Lingyun Liu Yi Bingming Miao Xiaopeng Nair Nitin Xiaoyan Liu Jazic Ina Laird Glen Xiaolong Luo
+ PDF Chat	Introduction to Special Issue on Leveraging External Data to Improve Trial Efficiency	2022	Lanju Zhang Naitee Ting
+	A Simple Approach to Incorporating Historical Control Data in Clinical Trial Design and Analysis	2022	Lanju Zhang Zailong Wang Li Wang Lu Cui Jeremy Sokolove Ivan S. F. Chan
+	Statistical Considerations in Design, Execution, and Analysis of Multiregional Clinical Trials: Consistency Evaluation and Adaptive Trials	2021	Lanju Zhang Weining Robieson
+	Lessons Learned from Actual Multi-Regional Clinical Trials with Signals of Treatment Effect Heterogeneity	2021	Bruce Binkowitz Gang Li Hui Quan Gordon Lan Soo Peter Ouyang Weining Robieson William Yang Wang Sammy Yuan Yoko Tanaka Josh Chen
+ PDF Chat	A practical response adaptive block randomization (RABR) design with analytic type I error protection	2021	Tianyu Zhan Lu Cui Ziqian Geng Lanju Zhang Yihua Gu Ivan S. F. Chan
+	Investigating Synthetic Controls with Randomized Clinical Trial Data in Rheumatoid Arthritis Studies	2021	Zailong Wang Zhuqing Yu Chen Su Lanju Zhang
+	An automation-based adaptive seamless design for dose selection and confirmation with improved power and efficiency	2021	Lu Cui Tianyu Zhan Lanju Zhang Ziqian Geng Yihua Gu Ivan S. F. Chan
+	Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays	2020	Thorsten Pflanzner Yuanyuan Duan Uyentrang N. Bui Lanju Zhang Stephen E. Hartman Martina Kron
+	A Practical Response Adaptive Block Randomization Design with Analytic Type I Error Protection	2020	Tianyu Zhan Lu Cui Ziqian Geng Lanju Zhang Yihua Gu Ivan S. F. Chan
+	Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity	2020	Gang Li Hui Quan Gordon Lan Soo Peter Ouyang Fei Chen Weining Robieson William Yang Wang Bruce Binkowitz Shuai Yuan Yoko Tanaka
+	Issues Related to Subgroup Analyses and Use of Intensive Stratification	2020	Lu Cui Tu Xu Lanju Zhang
+	Reducing Patient Burden in Clinical Trials Through the Use of Historical Controls: Appropriate Selection of Historical Data to Minimize Risk of Bias	2019	Jessica Lim Li Wang Nicky Best Jeen Liu Jiacheng Yuan Florence H. Yong Lanju Zhang Rosalind Walley Alice Gosselin Robert Roebling
+	Sequential monitoring of response-adaptive randomized clinical trials with sample size re-estimation	2019	Lei Gao Hongjian Zhu Lanju Zhang
+	Optimal Adaptive Phase III Design with Interim Sample Size and Dose Determination	2019	Lanju Zhang Lu Cui Yaoyao Xu
+	Review of Statistical Issues in Pragmatic Clinical Trials in Current Drug Development Environment	2019	Dingfeng Jiang Kun Chen Saurabh Mukhopadhyay Nareen Katta Lanju Zhang
+	On the efficiency of adaptive sample size design	2018	Lu Cui Lanju Zhang
+	Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity	2018	Gang Li Hui Quan Gordon Lan Soo Peter Ouyang Fei Chen Weining Robieson William Yang Wang Bruce Binkowitz Shuai Yuan Yoko Tanaka
+	AICc for Calibration Model Selection in Assay Validation	2017	Lanju Zhang Charles Y. Tan David LeBlond
+	Optimal adaptive group sequential design with flexible timing of sample size determination	2017	Lu Cui Lanju Zhang Bo Yang
+	Statistical Methods for CMC Applications	2017	Richard K. Burdick David LeBlond Lori B. Pfahler Jorge Quiroz Leslie Sidor Kimberly Vukovinsky Lanju Zhang
+	Analytical Comparability and Similarity	2017	Richard K. Burdick David LeBlond Lori B. Pfahler Jorge Quiroz Leslie Sidor Kimberly Vukovinsky Lanju Zhang
+	Process Design: Stage 1 of the FDA Process Validation Guidance	2017	Richard K. Burdick David LeBlond Lori B. Pfahler Jorge Quiroz Leslie Sidor Kimberly Vukovinsky Lanju Zhang
+	Process Qualification: Stage 2 of the FDA Process Validation Guidance	2017	Richard K. Burdick David LeBlond Lori B. Pfahler Jorge Quiroz Leslie Sidor Kimberly Vukovinsky Lanju Zhang
+	Introduction	2017	Richard K. Burdick David LeBlond Lori B. Pfahler Jorge Quiroz Leslie Sidor Kimberly Vukovinsky Lanju Zhang
+	Regional efficacy assessment in multiregional clinical development	2016	Yijie Zhou Lu Cui Bo Yang Lanju Zhang Frank Shen
+	Optimal flexible sample size design with robust power	2016	Lanju Zhang Lu Cui Bo Yang
+	Statistical Applications in Design and Analysis of In Vitro Safety Screening Assays	2016	Lei Shu Gary A. Gintant Lanju Zhang
+	Design and Evaluation of Drug Combination Studies	2016	Lanju Zhang Hyuna Yang
+	Nonclinical Statistics for Pharmaceutical and Biotechnology Industries	2016	Lanju Zhang
+	An ROC Approach to Evaluate Interim Go/No-Go Decision-Making Quality with Application to Futility Stopping in the Clinical Trial Designs	2016	Deli Wang Lu Cui Lanju Zhang Bo Yang
+	Enrichment design with patient population augmentation	2015	Bo Yang Yijie Zhou Lanju Zhang Lu Cui
+	Non-Normal Random Effects Models for Immunogenicity Assay Cut Point Determination	2014	Jianchun Zhang Binbing Yu Lanju Zhang Lorin Roskos Laura K. Richman Harry Yang
+ PDF Chat	Two Approaches to Incorporate Clinical Data Uncertainty into Multiple Criteria Decision Analysis for Benefit-Risk Assessment of Medicinal Products	2014	Shihua Wen Lanju Zhang Bo Yang
+ PDF Chat	A New Bliss Independence Model to Analyze Drug Combination Data	2014	Wei Zhao Kris F. Sachsenmeier Lanju Zhang Erin Sult Robert E. Hollingsworth Harry Yang
+	Response-Adaptive Randomization for Clinical Trials	2014	Lanju Zhang William F. Rosenberger
+	Statistical methods and tool for cut point analysis in immunogenicity assays	2013	Lanju Zhang Jianchun Jason Zhang Robert Kubiak Harry Yang
+	Adaptive Survival Trials	2012	William F. Rosenberger Lanju Zhang
+	A Two-Stage Response Surface Approach to Modeling Drug Interaction	2012	Wei Zhao Lanju Zhang Lingmin Zeng Harry Yang
+	Adaptive Randomization in Clinical Trials	2012	Lanju Zhang William F. Rosenberger
+	Evaluations of Parallelism Testing Methods Using ROC Analysis	2011	Harry Yang Lanju Zhang
+	Optimal Response-Adaptive Randomization for Clinical Trials	2010	Lanju Zhang William F. Rosenberger
+	Adaptive Survival Trials	2010	William F. Rosenberger Lanju Zhang
+	A probabilistic model for risk assessment of residual host cell DNA in biological products	2010	Harry Yang Lanju Zhang Mark Galinski
+	Tolerance Limits for a Ratio of Normal Random Variables	2009	Lanju Zhang Thomas Mathew Harry Yang K. Krishnamoorthy Iksung Cho
+	Test Homogeneity of Risk Difference Across Subgroups in Clinical Trials	2009	Lanju Zhang Harry Yang Iksung Cho
+	Characterizations of maximum fractional <mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" altimg="si1.gif" display="inline" overflow="scroll"><mml:mrow><mml:mo>(</mml:mo><mml:mi>g</mml:mi><mml:mo>,</mml:mo><mml:mi>f</mml:mi><mml:mo>)</mml:mo></mml:mrow></mml:math>-factors of graphs	2008	Guizhen Liu Lanju Zhang
+	Optimal Failure-Success Response-Adaptive Designs for Binary Responses	2007	Lanju Zhang Atanu Biswas
+	Optimal Response‐Adaptive Designs for Continuous Responses in Phase III Trials	2007	Atanu Biswas Rahul Bhattachary Lanju Zhang
+	Toughness and the existence of fractional k-factors of graphs	2007	Guizhen Liu Lanju Zhang
+	Maximum fractional factors in graphs	2007	Guizhen Liu Qinglin Yu Lanju Zhang
+ PDF Chat	Response-Adaptive Randomization for Survival Trials: The Parametric Approach	2007	Lanju Zhang William F. Rosenberger
+	Response‐Adaptive Randomization for Clinical Trials with Continuous Outcomes	2005	Lanju Zhang William F. Rosenberger
+	PROPERTIES OF FRACTIONAL K -FACTORS OF GRAPHS	2005	Guizhen Liu Lanju Zhang
+	Bandwidth selections for a class of smooth quantile estimators	2002	Lanju Zhang

Common Coauthors

Coauthor	Papers Together
Lu Cui	12
Harry Yang	8
William F. Rosenberger	7
David LeBlond	6
Jorge Quiroz	5
Leslie Sidor	5
Kimberly Vukovinsky	5
Richard K. Burdick	5
Lori B. Pfahler	5
Bo Yang	4
Guizhen Liu	4
Weining Robieson	4
Ziqian Geng	3
Josh Chen	3
Bruce Binkowitz	3
Soo Peter Ouyang	3
William Yang Wang	3
Gordon Lan	3
Hui Quan	3
Paul Gallo	3
Ivan S. F. Chan	3
Yihua Gu	3
Tianyu Zhan	3
Zailong Wang	2
Gang Li	2
Iksung Cho	2
Li Wang	2
Shuai Yuan	2
Song Yang	2
Yoko Tanaka	2
Atanu Biswas	2
Fei Chen	2
Yijie Zhou	2
Nobushige Matsuoka	2
Bo Yang	1
Kert Viele	1
Lorin Roskos	1
K. Krishnamoorthy	1
S. Mukhopadhyay	1
Yoko Tanaka	1
Nareen Katta	1
Shihua Wen	1
Jessica Lim	1
Jiacheng Yuan	1
Jianchun Jason Zhang	1
Laird Glen	1
Xiaoyan Liu	1
Chen Su	1
Gang Li	1
Kun Chen	1

Commonly Cited References

Action	Title	Year	Authors	# of times referenced
+	Modification of Sample Size in Group Sequential Clinical Trials	1999	Lu Cui H. M. James Hung Sue‐Jane Wang	9
+ PDF Chat	Asymptotic properties of doubly adaptive biased coin designs for multitreatment clinical trials	2004	Feifang Hu Zhang Li	8
+	Optimality, Variability, Power	2003	Feifang Hu William F. Rosenberger	8
+	Optimal Adaptive Designs for Binary Response Trials	2001	William F. Rosenberger Nigel Stallard Anastasia Ivanova Cherice N. Harper Michelle L. Ricks	8
+ PDF Chat	Adaptive Sample Size Calculations in Group Sequential Trials	1999	Walter Lehmacher Gernot Wassmer	7
+	Optimal Adaptive Designs in Phase III Clinical Trials for Continuous Responses with Covariates	2004	Atanu Biswas Saumen Mandal	6
+	Response‐Adaptive Randomization for Clinical Trials with Continuous Outcomes	2005	Lanju Zhang William F. Rosenberger	6
+	Adaptive Group Sequential Designs for Clinical Trials: Combining the Advantages of Adaptive and of Classical Group Sequential Approaches	2001	Hans‐Helge Müller H. Schäfer	6
+	A play-the-winner-type urn design with reduced variability	2003	Anastasia Ivanova	6
+	Randomization in Clinical Trials	2002	William F. Rosenberger John M. Lachin	5
+	The Randomized Play-the-Winner Rule in Medical Trials	1978	L. J. Wei S. D. Durham	5
+	Evaluating the adaptive performance of flexible sample size designs with treatment difference in an interval	2007	G. Frank Liu Guangrui Zhu Lu Cui	5
+ PDF Chat	Adaptive increase in sample size when interim results are promising: A practical guide with examples	2010	Cyrus R. Mehta Stuart J. Pocock	5
+ PDF Chat	Response-Adaptive Randomization for Survival Trials: The Parametric Approach	2007	Lanju Zhang William F. Rosenberger	5
+	Increasing the sample size when the unblinded interim result is promising	2004	Y. H. Joshua Chen David L. DeMets K. K. Gordon Lan	5
+	An adaptive randomized design with application to estimation	2001	Vincent Melfi Connie Page Margarida Geraldes	5
+	The Theory of Response‐Adaptive Randomization in Clinical Trials	2006	Feifang Hu William F. Rosenberger	5
+	The doubly adaptive biased coin design for sequential clinical trials	1994	Jeffrey R. Eisele	5
+	Type I error in sample size re‐estimations based on observed treatment difference	2001	Zhenming Shun William Yuan William E. Brady Huang Hsu	4
+	Sample Size Re-Estimation for Adaptive Sequential Design in Clinical Trials	2008	Ping Gao James H. Ware Cyrus R. Mehta	4
+ PDF Chat	Twenty‐five years of confirmatory adaptive designs: opportunities and pitfalls	2015	Péter Bauer Frank Bretz Vladimir Dragalin Franz König Gernot Wassmer	4
+	Optimal flexible sample size design with robust power	2016	Lanju Zhang Lu Cui Bo Yang	4
+	Adaptive designs for normal responses with prognostic factors	2001	Uttam Bandyopadhyay	4
+	The combination of randomized and historical controls in clinical trials	1976	Stuart J. Pocock	4
+	Discrete Sequential Boundaries for Clinical Trials	1983	K. K. Gordon Lan David L. DeMets	4
+	Maximizing power and minimizing treatment failures in clinical trials	2004	William F. Rosenberger Feifang Hu	4
+ PDF Chat	Asymptotic Inference with Response-Adaptive Treatment Allocation Designs	1993	William F. Rosenberger	4
+	Implementing Optimal Allocation in Sequential Binary Response Experiments	2007	Yevgen Tymofyeyev William F. Rosenberger Feifang Hu	4
+	Group Sequential Methods with Applications to Clinical Trials	1999	Christopher Jennison Bruce W. Turnbull	4
+	Group sequential and discretized sample size re‐estimation designs: a comparison of flexibility	2012	Xiaoru Wu Lu Cui	4
+	Fractional graph theory	1978	Claude Berge	4
+	Robust meta‐analytic‐predictive priors in clinical trials with historical control information	2014	Heinz Schmidli Sandro Gsteiger Satrajit Roychoudhury Anthony O’Hagan David J. Spiegelhalter Beat Neuenschwander	3
+	Adaptive survival trials	1997	William F. Rosenberger Padmanabhan Seshaiyer	3
+	Seamless Phase II/III Combination Study Through Response Adaptive Randomization	2007	Lin Wang Lu Cui	3
+ PDF Chat	A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability	1987	Donald J. Schuirmann	3
+	Adaptive designs for confirmatory clinical trials	2009	Frank Bretz Franz Koenig Werner Brannath Ekkehard Glimm Martin Posch	3
+	A group sequential, response-adaptive design for randomized clinical trials	2003	Theodore Karrison Dezheng Huo Rick Chappell	3
+	The role of internal pilot studies in increasing the efficiency of clinical trials	1990	Janet Wittes Erica Brittain	3
+	Group sequential methods in the design and analysis of clinical trials	1977	Stuart J. Pocock	3
+	Beyond the t-Test: Statistical Equivalence Testing	2005	Giselle B Limentani Moira C Ringo Feng Ye Mandy L Berquist Ellen O McSorley	3
+	Randomization in Clinical Trials: Theory and Practice	2002	William F. Rosenberger John M. Lachin	3
+	Assessing consistent treatment effect in a multi‐regional clinical trial: a systematic review	2010	Joshua Chen Hui Quan Bruce Binkowitz Soo Peter Ouyang Yoko Tanaka Gang Li Shailendra Menjoge Ekopimo Ibia	3
+	A Conditional Power Approach to the Evaluation of Predictive Power	2009	K. K. Gordon Lan Peter Hu Michael A. Proschan	3
+	Forcing a sequential experiment to be balanced	1971	Bradley Efron	3
+	Approximately Optimal One-Parameter Boundaries for Group Sequential Trials	1987	Samuel K. Wang Anastasios A. Tsiatis	3
+	Discrete sequential boundaries for clinical trials	1983	K. K. Gordon Lan David L. DeMets	3
+	A Multiple Testing Procedure for Clinical Trials	1979	Peter C. O’Brien Thomas R. Fleming	3
+	Efficient randomized-adaptive designs	2009	Feifang Hu Zhang Li Xuming He	3
+	Designed Extension of Studies Based on Conditional Power	1995	Michael A. Proschan Sally Hunsberger	3
+	PLAY THE WINNER FOR PHASE II/III CLINICAL TRIALS	1996	Qi Yao Lianjie Wei	3