Daniel J. Sargent

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All published works

Action	Title	Year	Authors
+	Supplementary Figure 1 from Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2023	Ming‐Wen An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+	CCR Translation for This Article from Achieving Sufficient Accrual to Address the Primary Endpoint in Phase III Clinical Trials from U.S. Cooperative Oncology Groups	2023	Anneke T. Schroen Gina R. Petroni Hongkun Wang Monika J. Thielen Robert Gray Jacqueline Benedetti Xiaofei F. Wang Daniel J. Sargent D. Lawrence Wickerham Walter M. Cronin
+	Data from Achieving Sufficient Accrual to Address the Primary Endpoint in Phase III Clinical Trials from U.S. Cooperative Oncology Groups	2023	Anneke T. Schroen Gina R. Petroni Hongkun Wang Monika J. Thielen Robert Gray Jacqueline Benedetti Xiaofei F. Wang Daniel J. Sargent D. Lawrence Wickerham Walter M. Cronin
+	Data from Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2023	Ming‐Wen An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+	Data from Achieving Sufficient Accrual to Address the Primary Endpoint in Phase III Clinical Trials from U.S. Cooperative Oncology Groups	2023	Anneke T. Schroen Gina R. Petroni Hongkun Wang Monika J. Thielen Robert Gray Jacqueline Benedetti Xiaofei F. Wang Daniel J. Sargent D. Lawrence Wickerham Walter M. Cronin
+	Data from Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2023	Ming‐Wen An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+	Supplementary Figure 2 from Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2023	Ming‐Wen An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+	Supplementary Figure 1 from Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2023	Ming‐Wen An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+	Supplementary Figure 2 from Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2023	Ming‐Wen An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+	CCR Translation for This Article from Achieving Sufficient Accrual to Address the Primary Endpoint in Phase III Clinical Trials from U.S. Cooperative Oncology Groups	2023	Anneke T. Schroen Gina R. Petroni Hongkun Wang Monika J. Thielen Robert Gray Jacqueline Benedetti Xiaofei F. Wang Daniel J. Sargent D. Lawrence Wickerham Walter M. Cronin
+	Missing tumor measurement (TM) data in the search for alternative TM-based endpoints in cancer clinical trials	2019	Ming-Wen An Jun Tang Axel Grothey Daniel J. Sargent Fang‐Shu Ou Sumithra J. Mandrekar
+	Combining Survival and Toxicity Effect Sizes from Clinical Trials: NCCTG 89-20-52 (Alliance)	2018	Brittny Major‐Elechi Paul J. Novotny Jasvinder A. Singh James A. Bonner Amylou C. Dueck Daniel J. Sargent Axel Grothey Jeff A. Sloan
+ PDF Chat	An adaptive multi-stage phase I dose-finding design incorporating continuous efficacy and toxicity data from multiple treatment cycles	2018	Yu Du Jun Yin Daniel J. Sargent Sumithra J. Mandrekar
+	Choice of Endpoints in Cancer Clinical Trials	2018	Mei‐Yin C. Polley Wenting Wu Daniel J. Sargent
+ PDF Chat	Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data	2017	Jun Yin Xavier Paolettí Daniel J. Sargent Sumithra J. Mandrekar
+	A hierarchical Bayesian design for randomized Phase II clinical trials with multiple groups	2017	Jun Yin Rui Qin Daniel J. Sargent Charles Erlichman Qian Shi
+ PDF Chat	Use of Bayesian Decision Analysis to Minimize Harm in Patient-Centered Randomized Clinical Trials in Oncology	2017	Vahid Montazerhodjat Shomesh E. Chaudhuri Daniel J. Sargent Andrew W. Lo
+	Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer: a retrospective analysis	2016	Julia Wilkerson Kald Abdallah Charles Hugh-Jones Greg Curt Mace L. Rothenberg Ronit Simantov Martin J. Murphy Joseph Morrell Joel Beetsch Daniel J. Sargent
+	Evaluation of Progression-Free Survival (PFS) As a Surrogate Endpoint for Overall Survival (OS) in First-Line Therapy for Diffuse Large B-Cell Lymphoma (DLBCL): Findings from the Surrogate Endpoint in Aggressive Lymphoma (SEAL) Analysis of Individual Patient Data from 7507 Patients	2016	Qian Shi Norbert Schmitz Christopher R. Flowers Fang‐Shu Ou David Cunningham Michael Pfreundschuh John F. Seymour Ulrich Jaeger Thomas M. Habermann Corinne Haïoun
+	Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples	2016	Lindsay A. Renfro Daniel J. Sargent
+ PDF Chat	A Bayesian dose‐finding design incorporating toxicity data from multiple treatment cycles	2016	Jun Yin Rui Qin Monia Ezzalfani Daniel J. Sargent Sumithra J. Mandrekar
+	Étude de simulations pour comparer différents designs d’essais randomisés en termes de bénéfice et risque à long terme en considérant une succession d’essais, dans les maladies rares	2016	Mohamed Amine Bayar Gwénaël Le Teuff Stefan Michiels Daniel J. Sargent Marie‐Cécile Le Deley
+	Testing of evaluation bias for progression free survival endpoint in oncology clinical trials	2016	Yan Sun Wenting Wu Daniel J. Sargent
+	New insights into the evaluation of randomized controlled trials for rare diseases over a long‐term research horizon: a simulation study	2016	Mohamed Amine Bayar Gwénaël Le Teuff Stefan Michiels Daniel J. Sargent Marie‐Cécile Le Deley
+ PDF Chat	Clinical trial designs incorporating predictive biomarkers	2016	Lindsay A. Renfro Himel Mallick Ming-Wen An Daniel J. Sargent Sumithra J. Mandrekar
+	Design and analysis of clinical trials	2016	Daniel J. Sargent Qian Shi
+	Data from: Testing of Evaluation Bias for Progression Free Survival Endpoint in Oncology Clinical Trials	2016	Yan Sun Wenting Wu Daniel J. Sargent
+ PDF Chat	Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods	2015	Ming-Wen An Yu Han Jeffrey P. Meyers Jan Bogaerts Daniel J. Sargent Sumithra J. Mandrekar
+	Statistics and Clinical Trials	2015	Qian Shi Wenting Wu Daniel J. Sargent
+ PDF Chat	The Fundamental Difficulty With Evaluating the Accuracy of Biomarkers for Guiding Treatment	2015	Holly Janes Margaret S. Pepe Lisa M. McShane Daniel J. Sargent Patrick J. Heagerty
+	Flexible Bayesian Survival Modeling with Semiparametric Time-Dependent and Shape-Restricted Covariate Effects	2015	Thomas A. Murray Brian P. Hobbs Daniel J. Sargent Bradley P. Carlin
+ PDF Chat	Genotype-based clinical trials in cardiovascular disease	2015	Naveen L. Pereira Daniel J. Sargent Michael E. Farkouh Charanjit S. Rihal
+	Challenges of Using Predictive Biomarkers in Clinical Trials	2015	Sumithra J. Mandrekar Daniel J. Sargent
+	Key statistical concepts in cancer research.	2015	Qian Shi Daniel J. Sargent
+ PDF Chat	Improving Efficiency in Clinical Trials Using Auxiliary Information: Application of a Multi-State Cure Model	2015	A. S. C. Conlon Jeremy M. G. Taylor Daniel J. Sargent
+ PDF Chat	The Direct Assignment Option as a Modular Design Component: An Example for the Setting of Two Predefined Subgroups	2015	Ming-Wen An Xin Lu Daniel J. Sargent Sumithra J. Mandrekar
+ PDF Chat	Resampling the N9741 Trial to Compare Tumor Dynamic Versus Conventional End Points in Randomized Phase II Trials	2014	Manish Sharma Elizabeth Gray Richard M. Goldberg Daniel J. Sargent Theodore Karrison
+	Shifting paradigms in cancer clinical trial design	2014	Daniel J. Sargent Edward L. Korn
+ PDF Chat	Raising the Bar for Antineoplastic Agents: How to Choose Threshold Values for Superiority Trials in Advanced Solid Tumors	2014	Alberto F. Sobrero Alessandro Pastorino Daniel J. Sargent Paolo Bruzzi
+ PDF Chat	Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee	2014	Channing J. Paller Penelope A. Bradbury S. Percy Ivy Lesley Seymour Patricia LoRusso Laurence H. Baker Larry Rubinstein Erich Huang Deborah Collyar Susan Groshen
+ PDF Chat	Impact of Copula Directional Specification on Multi-Trial Evaluation of Surrogate End Points	2014	Lindsay A. Renfro Hongwei Shang Daniel J. Sargent
+	Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine.	2014	Sumithra J. Mandrekar Daniel J. Sargent
+	Combining survival and toxicity effect sizes from clinical trials into an interpretable, quality-adjusted survival effect size estimate of treatment efficacy.	2014	Jeff A. Sloan Brittny Major Paul J. Novotny Axel Grothey Randolph S. Marks Daniel J. Sargent Amylou C. Dueck
+ PDF Chat	Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment	2014	Ming-Wen An Sumithra J. Mandrekar Martin J. Edelman Daniel J. Sargent
+ PDF Chat	Center-within-trial versus trial-level evaluation of surrogate endpoints	2014	Lindsay A. Renfro Qian Shi Yuan Xue Junlong Li Hongwei Shang Daniel J. Sargent
+ PDF Chat	Randomized Phase II Clinical Trials	2014	Sin‐Ho Jung Daniel J. Sargent
+	Adaptive randomized phase II design for biomarker threshold selection and independent evaluation.	2014	Lindsay A. Renfro Christina Coughlin Axel Grothey Daniel J. Sargent
+	Overview: biostatistician's role in oncology clinical trials-strive for sound, efficient and practical studies.	2014	Qian Shi Daniel J. Sargent
+ PDF Chat	Multi‐state models for colon cancer recurrence and death with a cured fraction	2013	A. S. C. Conlon Jeremy M. G. Taylor Daniel J. Sargent
+ PDF Chat	Calibration of Quality-Adjusted Life Years for Oncology Clinical Trials	2013	Jeff A. Sloan Daniel J. Sargent Paul J. Novotny Paul A. Decker Randolph S. Marks Heidi Nelson
+	Application of Tumor Measurement–Based Metrics in the Real World	2013	Ming-Wen An Sumithra J. Mandrekar Daniel J. Sargent
+	Statistical issues in the validation of prognostic, predictive, and surrogate biomarkers	2013	Daniel J. Sargent Sumithra J. Mandrekar
+	A phase II flexible screening design allowing for interim analysis and comparison with historical control	2013	Wenting Wu Brian M. Bot Yan Hu Susan Geyer Daniel J. Sargent
+ PDF Chat	Adaptive adjustment of the randomization ratio using historical control data	2013	Brian P. Hobbs Bradley P. Carlin Daniel J. Sargent
+ PDF Chat	A review of phase II trial designs for initial marker validation	2013	Sumithra J. Mandrekar Ming-Wen An Daniel J. Sargent
+	A phase II trial design with direct assignment option for initial marker validation.	2012	Sumithra J. Mandrekar Ming‐Wen An Daniel J. Sargent
+ PDF Chat	Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models	2012	Brian P. Hobbs Daniel J. Sargent Bradley P. Carlin
+ PDF Chat	On Bayesian methods of exploring qualitative interactions for targeted treatment	2012	Wei Chen Debashis Ghosh Trivellore E. Raghunathan Maxim Norkin Daniel J. Sargent Gerold Bepler
+ PDF Chat	A 2-Stage Phase II Design with Direct Assignment Option in Stage II for Initial Marker Validation	2012	Ming-Wen An Sumithra J. Mandrekar Daniel J. Sargent
+	Relationship between overall survival and progression-free survival for recent NCCTG glioblastoma multiforme trials.	2012	Wenting Wu Evanthia Galanis Jan C. Buckner Kurt A. Jaeckle Daniel J. Sargent
+ PDF Chat	Taking the long view: how to design a series of Phase III trials to maximize cumulative therapeutic benefit	2012	Marie‐Cécile Le Deley Karla V. Ballman Julien Marandet Daniel J. Sargent
+	From isolated hypotheses to connected practical studies: statisticians’ role in a seamless targeted therapy development	2012	Qian Shi Daniel J. Sargent
+	Phase 2 trial design in neuro-oncology revisited: a report from the RANO group	2012	Evanthia Galanis Wenting Wu Timothy F. Cloughesy Kathleen R. Lamborn Bhupinder Mann Patrick Y. Wen David A. Reardon Wolfgang Wick David Macdonald Terri S. Armstrong
+	CRM Trials for Assessing Toxicity and Efficacy	2012	Sumithra J. Mandrekar Daniel J. Sargent
+	Biomarkers, subgroup evaluation, and clinical trial design.	2012	Stuart G. Baker Barnett S. Kramer Daniel J. Sargent Marco Bonetti
+	Bayesian adjusted <i>R</i><sup>2</sup> for the meta‐analytic evaluation of surrogate time‐to‐event endpoints in clinical trials	2011	Lindsay A. Renfro Qian Shi Daniel J. Sargent Bradley P. Carlin
+ PDF Chat	Design of clinical trials for biomarker research in oncology	2011	Sumithra J. Mandrekar Daniel J. Sargent
+ PDF Chat	Achieving Sufficient Accrual to Address the Primary Endpoint in Phase III Clinical Trials from U.S. Cooperative Oncology Groups	2011	Anneke T. Schroen Gina R. Petroni Hongkun Wang Monika J. Thielen Robert J. Gray Jacqueline Benedetti Xiaofei F. Wang Daniel J. Sargent D. Lawrence Wickerham Walter M. Cronin
+ PDF Chat	Using cure models and multiple imputation to utilize recurrence as an auxiliary variable for overall survival	2011	A. S. C. Conlon Jeremy M. G. Taylor Daniel J. Sargent Greg Yothers
+	157 INVITED Cross-over in Oncology Clinical Trials – Statistical Issues	2011	Daniel J. Sargent
+	1206 ORAL Smaller, Faster Phase III Trials – New Approach for Assessing Targeted Agents?	2011	M.C. Le Delev KV Ballman Daniel J. Sargent
+ PDF Chat	Comparison of Continuous versus Categorical Tumor Measurement–Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2011	Ming-Wen An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+ PDF Chat	Predicting Treatment Effect from Surrogate Endpoints and Historical Trials: An Extrapolation Involving Probabilities of a Binary Outcome or Survival to a Specific Time	2011	Stuart G. Baker Daniel J. Sargent Marc Buyse Tomasz Burzykowski
+ PDF Chat	Bayesian Adaptive Trial Design for a Newly Validated Surrogate Endpoint	2011	Lindsay A. Renfro Bradley P. Carlin Daniel J. Sargent
+	Statistical Considerations for the Next Generation of Clinical Trials	2011	Wenting Wu Qian Shi Daniel J. Sargent
+ PDF Chat	Rejoinder for “Meta‐analysis for Surrogacy: Accelerated Failure Time Models and Semicompeting Risks Modeling”	2011	Debashis Ghosh Jeremy M. G. Taylor Daniel J. Sargent
+ PDF Chat	Meta‐analysis for Surrogacy: Accelerated Failure Time Models and Semicompeting Risks Modeling	2011	Debashis Ghosh Jeremy M. G. Taylor Daniel J. Sargent
+	Comparison of innovative estimation of efficacy to standard using the ACCENT database.	2011	Judith‐Anne W. Chapman Chris O’Callaghan Nianping Hu Keyue Ding Greg Yothers Paul J. Catalano Qian Qian Shi Richard Gray Michael J. OʼConnell Daniel J. Sargent
+	Smaller, faster trials: The right way to assess new targeted agents? A simulation study.	2011	M. Le Deley KV Ballman Daniel J. Sargent
+	Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group	2011	A Stone William D. Bushnell Jon Denne Daniel J. Sargent Ohad Amit C. CHEN R. Bailey-Iacona Jeffrey D. Helterbrand Grant Williams
+ PDF Chat	Comparative assessment of trial-level surrogacy measures for candidate time-to-event surrogate endpoints in clinical trials	2011	Qian Shi Lindsay A. Renfro Brian M. Bot Tomasz Burzykowski Marc Buyse Daniel J. Sargent
+ PDF Chat	All-Comers versus Enrichment Design Strategy in Phase II Trials	2011	Sumithra J. Mandrekar Daniel J. Sargent
+ PDF Chat	Hierarchical Commensurate and Power Prior Models for Adaptive Incorporation of Historical Information in Clinical Trials	2011	Brian P. Hobbs Bradley P. Carlin Sumithra J. Mandrekar Daniel J. Sargent
+ PDF Chat	Causal assessment of surrogacy in a meta-analysis of colorectal cancer trials	2011	Y. Li Jeremy M. G. Taylor Michael R. Elliott Daniel J. Sargent
+ PDF Chat	Comparison of Continuous versus Categorical Tumor Measurement-Based Metrics to Predict Overall Survival in Cancer Treatment Trials	2011	Ming An Sumithra J. Mandrekar Megan E. Branda Shauna L. Hillman Alex A. Adjei Henry C. Pitot Richard M. Goldberg Daniel J. Sargent
+ PDF Chat	Optimism bias leads to inconclusive results—an empirical study	2010	Benjamin Djulbegović Ambuj Kumar Anja Magazin Anneke T. Schroen Heloisa P. Soares Iztok Hozo Mike Clarke Daniel J. Sargent Michael J. Schell
+	Phase III Clinical Trials with Anticancer Agents	2010	Wendy R. Parulekar Daniel J. Sargent
+ PDF Chat	Designing a Randomized Clinical Trial to Evaluate Personalized Medicine: A New Approach Based on Risk Prediction	2010	Stuart G. Baker Daniel J. Sargent
+ PDF Chat	Clinical Trials Data Collection: When Less Is More	2010	Daniel J. Sargent Stephen L. George
+ PDF Chat	Causal Effects of Treatments for Informative Missing Data due to Progression/Death	2010	Keunbaik Lee Michael J. Daniels Daniel J. Sargent
+ PDF Chat	Randomized Phase II Trials: Time for a New Era in Clinical Trial Design	2010	Sumithra J. Mandrekar Daniel J. Sargent
+	Calibration of quality-adjusted life years (QALYs) for oncology clinical trials (OCT).	2010	Jeffrey A. Sloan P. J. Novotny Daniel J. Sargent Paul A. Decker Randolph S. Marks Heidi Nelson
+ PDF Chat	Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation	2010	Shauna L. Hillman Sumithra J. Mandrekar Brian M. Bot Ronald P. DeMatteo Edith A. Perez Karla V. Ballman Heidi Nelson Jan C. Buckner Daniel J. Sargent
+	Randomized Phase II Trials: Inevitable or Inadvisable?	2010	Hui Gan Axel Grothey Gregory R. Pond Malcolm J. Moore Lillian L. Siu Daniel J. Sargent
+ PDF Chat	Model‐based phase I designs incorporating toxicity and efficacy for single and dual agent drug combinations: Methods and challenges	2010	Sumithra J. Mandrekar Rui Qin Daniel J. Sargent
+ PDF Chat	Predictive biomarker validation in practice: lessons from real trials	2010	Sumithra J. Mandrekar Daniel J. Sargent
+ PDF Chat	Blinded Independent Central Review of the Progression-Free Survival Endpoint	2010	Ohad Amit Will Bushnell Lori E. Dodd Nancy Roach Daniel J. Sargent
+	Biomarkers and surrogate end points—the challenge of statistical validation	2010	Marc Buyse Daniel J. Sargent Axel Grothey Alastair Matheson Aimery de Gramont
+ PDF Chat	The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee	2010	Lesley Seymour S. Percy Ivy Daniel J. Sargent David R. Spriggs Laurence Baker Larry Rubinstein Mark J. Ratain M Blanc David B. Stewart John Crowley
+ PDF Chat	Comparison of Error Rates in Single-Arm Versus Randomized Phase II Cancer Clinical Trials	2010	Hui Tang Nathan R. Foster Axel Grothey Stephen M. Ansell Richard M. Goldberg Daniel J. Sargent
+ PDF Chat	What Constitutes Reasonable Evidence of Efficacy and Effectiveness to Guide Oncology Treatment Decisions?	2010	Daniel J. Sargent
+	Careers in statistics: Getting a job: What distinguishes you?	2010	Jeffrey Larson Keller Daniel J. Sargent
+	Meta-analysis for surrogacy: accelerated failure time models and semicompeting risks modelling	2010	Debashis Ghosh Jeremy M. G. Taylor Daniel J. Sargent
+ PDF Chat	Comparison of Error Rates in Single-Arm Versus Randomized Phase II Cancer Clinical Trials	2010	Hui Tang Nathan R. Foster Axel Grothey Stephen M. Ansell Richard M. Goldberg Daniel J. Sargent
+	Abstract C53: Dose-finding designs for combination therapies involving molecularly targeted agents	2009	Sumithra J. Mandrekar Rui Qin Daniel J. Sargent
+ PDF Chat	Role of Sensitivity Analyses in Assessing Progression-Free Survival in Late-Stage Oncology Trials	2009	Suman Bhattacharya Gwen Fyfe Robert J. Gray Daniel J. Sargent
+ PDF Chat	Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges	2009	Sumithra J. Mandrekar Daniel J. Sargent
+	Excessive false-positive errors in single-arm phase II trials: A simulation-based analysis	2009	Huayu Tang Nathan R. Foster Axel Grothey Steve Ansell Daniel J. Sargent
+	Challenges to accrual predictions to phase III cancer clinical trials: A survey of study chairs and lead statisticians of 248 NCI-sponsored trials	2009	Anneke T. Schroen Gina R. Petroni H. Wang Benjamin Djulbegović Craig L. Slingluff X. F. Wang Robert J. Gray Daniel J. Sargent Walter M. Cronin Jacqueline Benedetti
+ PDF Chat	Current Issues in Oncology Drug Development, with a Focus on Phase II Trials	2009	Daniel J. Sargent Jeremy M. G. Taylor
+ PDF Chat	Clinical Trial Designs for Predictive Biomarker Validation: One Size Does Not Fit All	2009	Sumithra J. Mandrekar Daniel J. Sargent
+	Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials	2009	Qian Shi Daniel J. Sargent
+ PDF Chat	Randomized Phase II Designs	2009	Larry Rubinstein John Crowley Percy Ivy Michael LeBlanc Daniel J. Sargent
+ PDF Chat	Alternate Endpoints for Screening Phase II Studies	2009	Neesha C. Dhani Dongsheng Tu Daniel J. Sargent Lesley Seymour Malcolm J. Moore
+	Early Stopping for Benefit in National Cancer Institute–Sponsored Randomized Phase III Trials: The System Is Working	2009	Daniel J. Sargent
+ PDF Chat	Bayesian Variable Selection with Joint Modeling of Categorical and Survival Outcomes: An Application to Individualizing Chemotherapy Treatment in Advanced Colorectal Cancer	2009	Wei Chen Debashis Ghosh Trivellore E. Raghunathan Daniel J. Sargent
+ PDF Chat	Genomic advances and their impact on clinical trial design	2009	Sumithra J. Mandrekar Daniel J. Sargent
+	Individual patient data analysis to assess modifications to the RECIST criteria	2008	Jan Bogaerts Robert Ford Daniel J. Sargent Lawrence H. Schwartz Larry Rubinstein Denis Lacombe Elizabeth A. Eisenhauer Jaap Verweij Patrick Therasse
+ PDF Chat	Validation of novel imaging methodologies for use as cancer clinical trial end-points	2008	Daniel J. Sargent Larry Rubinstein Lawrence H. Schwartz Janet Dancey Constantine Gatsonis Lori E. Dodd Lalitha Shankar
+	Optimising the design of phase II oncology trials: The importance of randomisation	2008	Mark J. Ratain Daniel J. Sargent
+	The value of preliminary data in power specifications based upon 64 NCCTG phase II/III treatment trials	2008	Xiaoyan Zhao Jeffrey A. Sloan Anita Hartung Jan C. Buckner Daniel J. Sargent Philip J. Stella
+	Surrogate endpoint validation: statistical elegance versus clinical relevance	2008	EM Green Greg Yothers Daniel J. Sargent
+ PDF Chat	Exploring and validating surrogate endpoints in colorectal cancer	2008	Tomasz Burzykowski Marc Buyse Greg Yothers Junichi Sakamoto Daniel J. Sargent
+	Clinical Trials of Novel and Targeted Therapies: Endpoints, Trial Design, and Analysis	2008	Vera J. Suman Amylou C. Dueck Daniel J. Sargent
+ PDF Chat	A false‐discovery‐rate‐based loss framework for selection of interactions	2007	Wei Chen Debashis Ghosh Trivellore E. Raghunathan Daniel J. Sargent
+ PDF Chat	Sound Footing or Slippery Slope? The Value of Secondary Analyses of Randomized Trials	2007	Daniel J. Sargent Axel Grothey
+	Questionable value of attribution when interpreting adverse event data: A joint evaluation by North Central Cancer Treatment Group (NCCTG) and American College of Surgeons Oncology Group (ACOSOG)	2007	Shauna L. Hillman Daniel J. Sargent Brian M. Bot Ronald P. DeMatteo Edith A. Perez Karla V. Ballman Sumithra J. Mandrekar
+ PDF Chat	Method for evaluating prediction models that apply the results of randomized trials to individual patients	2007	Andrew J. Vickers Michael W. Kattan Daniel J. Sargent
+	Clinical Trials of Novel and Targeted Therapies: Endpoints, Trial Design, and Analysis	2007	Vera J. Suman Amylou C. Dueck Daniel J. Sargent
+	Handbook of Statistics in Clinical Oncology, 2nd edition Edited by Crowley, J. and Ankerst, D. P.	2006	Daniel J. Sargent Sumithra J. Mandrekar Ann L. Oberg
+	Duffy-Santner Confidence Intervals for the Two-Stage Three-Outcome Design	2006	Alfred Furth Daniel J. Sargent
+	134 POSTER An adaptive phase I design for identifying a dose-outcome region for two drug combinations	2006	Daniel J. Sargent S. J. Mandrekar Y. Cui
+	An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations	2006	Sumithra J. Mandrekar Yue Cui Daniel J. Sargent
+	Should attribution be considered when interpreting adverse event data: A North Central Cancer Treatment Group (NCCTG) evaluation of a phase III placebo controlled trial	2006	Shauna L. Hillman Sumithra J. Mandrekar Brian M. Bot Edith A. Perez J. W. Kugler Alex A. Adjei Jan C. Buckner Daniel J. Sargent
+	General and statistical hierarchy of appropriate biologic endpoints.	2006	Daniel J. Sargent
+ PDF Chat	Pick the Winner Designs in Phase II Cancer Clinical Trials	2006	Sumithra J. Mandrekar Daniel J. Sargent
+	Pick the Winner Designs in Phase II Cancer Clinical Trials	2006	Sumithra J. Mandrekar Daniel J. Sargent
+ PDF Chat	Dealing With a Deluge of Data: An Assessment of Adverse Event Data on North Central Cancer Treatment Group Trials	2005	Michelle R. Mahoney Daniel J. Sargent Michael J. O’Connell Richard M. Goldberg Paul Schaefer Jan C. Buckner
+	An adaptive dose-finding design incorporating both toxicity and efficacy	2005	Wei Zhang Daniel J. Sargent Sumithra J. Mandrekar
+	How many new treatments are “breakthroughs”? Evaluation of innovations in cancer	2005	Amanika Kumar Heloisa P. Soares Fadila Serdarević Iztok Hozo Jan C. Buckner Robert J. Wells James V. Fiorica Suzanne K. Swan Daniel J. Sargent Benjamin Djulbegović
+	Clinical Trial Designs for Predictive Marker Validation in Cancer Treatment Trials	2005	Daniel J. Sargent Barbara A. Conley Carmen J. Allegra Laurence Collette
+	Random effects survival models gave a better understanding of heterogeneity in individual patient data meta-analyses	2005	Stefan Michiels B. Baujat C Mahé Daniel J. Sargent Jean‐Pierre Pignon
+	Clinical Trial Designs for Prospective Validation of Biomarkers	2005	Sumithra J. Mandrekar Axel Grothey Matthew P. Goetz Daniel J. Sargent
+	Gastrointestinal Cancers	2004	Daniel J. Sargent Rich Goldberg Paul J. Limburg
+	A new strategy for speeding Markov chain Monte Carlo algorithms	2003	Antonietta Mira Daniel J. Sargent
+	Early Detection of Toxicity and Adjustment of Ongoing Clinical Trials: The History and Performance of the North Central Cancer Treatment Group’s Real-Time Toxicity Monitoring Program	2002	Richard M. Goldberg Daniel J. Sargent Roscoe F. Morton Michelle R. Mahoney James E. Krook Michael J. O’Connell
+	A new graphic for quality adjusted life years (Q-TWiST) survival analysis: the Q-TWiST plot.	2002	Jeff A. Sloan Daniel J. Sargent Jed Lindman Cristine Allmer Delfino Vargas Chanes Edward T. Creagan James A. Bonner Michael J. O’Connell Robert J. Dalton Kendrith M. Rowland
+	Heterogeneity in an individual patient data meta-analysis: contribution of random effect survival models	2001	B. Baujat Cedric Mahé Daniel J. Sargent Jean‐Pierre Pignon
+	A flexible design for multiple armed screening trials	2001	Daniel J. Sargent Richard M. Goldberg
+	A Three-Outcome Design for Phase II Clinical Trials	2001	Daniel J. Sargent Victor K. Y. Chan Richard M. Goldberg
+	Comparison of artificial neural networks with other statistical approaches	2001	Daniel J. Sargent
+	Structured Markov Chain Monte Carlo	2000	Daniel J. Sargent James S. Hodges Bradley P. Carlin
+	Statistical Issues in Tumor Marker Studies	2000	Thomas F. Pajak Gary M. Clark Daniel J. Sargent Lisa M. McShane M. Elizabeth H. Hammond
+	Structured Markov Chain Monte Carlo	2000	Daniel J. Sargent James S. Hodges Bradley P. Carlin
+	Statistical methods frequently used in cancer research	1999	Georgene Schroeder Ayalew Tefferi Daniel J. Sargent
+	Sample Size and Design Considerations for Phase II Clinical Trials with Correlated Observations	1999	Daniel J. Sargent Jeff A. Sloan Sebastian Steven
+	A General Framework for Random Effects Survival Analysis in the Cox Proportional Hazards Setting	1998	Daniel J. Sargent
+ PDF Chat	CORRECTION: Robust Bayesian Approaches for Clinical Trial Monitoring, by Bradley P. Carlin and Daniel J. Sargent,Statistics in Medicine,15, 1093-1106 (1996)	1997	Bradley P. Carlin Daniel J. Sargent
+	CORRECTION: Robust Bayesian Approaches for Clinical Trial Monitoring, by Bradley P. Carlin and Daniel J. Sargent, Statistics in Medicine, 15, 1093–1106 (1996)	1997	Bradley P. Carlin Daniel J. Sargent
+	51 Sample size and design considerations for phase II clinical trials with correlated observations	1997	Daniel J. Sargent Jeff A. Sloan S. Stephen
+	A flexible approach to time-varying coefficients in the Cox regression setting.	1997	Daniel J. Sargent
+	ROBUST BAYESIAN APPROACHES FOR CLINICAL TRIAL MONITORING	1996	Bradley P. Carlin Daniel J. Sargent
+ PDF Chat	Robust Bayesian design and analysis of clinical trials via prior partitioning	1996	Daniel J. Sargent Bradley P. Carlin

Common Coauthors

Coauthor	Papers Together
Sumithra J. Mandrekar	43
Richard M. Goldberg	14
Bradley P. Carlin	12
Qian Shi	12
Shauna L. Hillman	11
Alex A. Adjei	9
Ming-Wen An	9
Megan E. Branda	8
Benjamin Djulbegović	8
Jeremy M. G. Taylor	8
Henry C. Pitot	8
Lindsay A. Renfro	8
Wenting Wu	7
Ming‐Wen An	7
Anneke T. Schroen	7
Axel Grothey	6
Jan C. Buckner	6
Jacqueline Benedetti	6
Jeff A. Sloan	6
Craig L. Slingluff	6
Walter M. Cronin	6
Axel Grothey	5
Monika J. Thielen	5
Brian M. Bot	5
Xiaofei F. Wang	5
Larry Rubinstein	5
D. Lawrence Wickerham	5
Gina R. Petroni	4
Marc Buyse	4
Greg Yothers	4
Michael J. OʼConnell	4
Jun Yin	4
Amylou C. Dueck	4
Debashis Ghosh	4
Brian P. Hobbs	4
Robert Gray	4
Edith A. Perez	3
Tomasz Burzykowski	3
Stuart G. Baker	3
Stefan Michiels	3
Trivellore E. Raghunathan	3
Randolph S. Marks	3
Nathan R. Foster	3
Hongkun Wang	3
Anna S. C. Conlon	3
Lesley Seymour	3
Marie‐Cécile Le Deley	3
Heidi Nelson	3
Robert J. Gray	3
Karla V. Ballman	3

Commonly Cited References

Action	Title	Year	Authors	# of times referenced
+	Clinical Trial Designs for Predictive Marker Validation in Cancer Treatment Trials	2005	Daniel J. Sargent Barbara A. Conley Carmen J. Allegra Laurence Collette	19
+	Design Issues of Randomized Phase II Trials and a Proposal for Phase II Screening Trials	2005	Larry Rubinstein Edward L. Korn Boris Freidlin Sally Hunsberger S. Percy Ivy Malcolm A. Smith	17
+ PDF Chat	Optimal two-stage designs for phase II clinical trials	1989	Richard Simon	14
+ PDF Chat	Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges	2009	Sumithra J. Mandrekar Daniel J. Sargent	13
+ PDF Chat	Evaluating the Efficiency of Targeted Designs for Randomized Clinical Trials	2004	Richard Simon Aboubakar Maitournam	13
+	A flexible design for multiple armed screening trials	2001	Daniel J. Sargent Richard M. Goldberg	13
+	Randomized phase II clinical trials.	1985	Richard Simon R. Wittes Susan S. Ellenberg	13
+ PDF Chat	Bayesian adaptive design for targeted therapy development in lung cancer — a step toward personalized medicine	2008	Xian Zhou Suyu Liu Edward S. Kim Roy S. Herbst J. Jack Lee	12
+	I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy	2009	AD Barker C C Sigman Kelloff Gj NM Hylton DA Berry L. Esserman	12
+	Surrogate endpoints in clinical trials: Definition and operational criteria	1989	Ross L. Prentice	12
+	Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer	1990	John O’Quigley Margaret S. Pepe Lloyd D. Fisher	11
+	Criteria for the Validation of Surrogate Endpoints in Randomized Experiments	1998	Marc Buyse Geert Molenberghs	11
+ PDF Chat	The validation of surrogate endpoints in meta-analyses of randomized experiments	2000	Marc Buyse Geert Molenberghs Tomasz Burzykowski Didier Renard Helena Geys	10
+ PDF Chat	Validation of Surrogate end Points in Multiple Randomized Clinical Trials with Failure Time end Points	2001	Tomasz Burzykowski Geert Molenberghs Marc Buyse Helena Geys Didier Renard	10
+	Dose‐Finding Based on Efficacy–Toxicity Trade‐Offs	2004	Peter F. Thall John D. Cook	10
+	Statistical validation of intermediate endpoints for chronic diseases	1992	Laurence S. Freedman Barry I. Graubard Arthur Schatzkin	9
+ PDF Chat	Biomarker-Adaptive Threshold Design: A Procedure for Evaluating Treatment With Possible Biomarker-Defined Subset Effect	2007	Wei Jiang Boris Freidlin Richard H. Simon	9
+	Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework	2001	Arthur J. Atkinson Wayne A. Colburn Victor G. DeGruttola David L. DeMets Gregory J. Downing Daniel F. Hoth John A. Oates Carl C. Peck Robert T. Schooley Bert Spilker	9
+ PDF Chat	On the efficiency of targeted clinical trials	2004	A. Maitournam Richard Simon	9
+	Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset	2007	Sue‐Jane Wang Robert T. O’Neill Hung Hung	8
+	One-Sample Multiple Testing Procedure for Phase II Clinical Trials	1982	Thomas R. Fleming	8
+	Review of Phase II Trial Designs Used in Studies of Molecular Targeted Agents: Outcomes and Predictors of Success in Phase III	2008	Robert H. El-Maraghi Elizabeth A. Eisenhauer	7
+ PDF Chat	Effective Incorporation of Biomarkers into Phase II Trials	2009	Lisa M. McShane Sally Hunsberger Alex A. Adjei	7
+ PDF Chat	Principal Stratification in Causal Inference	2002	Constantine Frangakis Donald B. Rubin	6
+ PDF Chat	Design of Phase II Cancer Trials Using a Continuous Endpoint of Change in Tumor Size: Application to a Study of Sorafenib and Erlotinib in Non Small-Cell Lung Cancer	2007	Theodore Karrison Michael L. Maitland Walter M. Stadler Mark J. Ratain	6
+	Surrogate threshold effect: an alternative measure for meta‐analytic surrogate endpoint validation	2006	Tomasz Burzykowski Marc Buyse	6
+	An adaptive dose-finding design incorporating both toxicity and efficacy	2005	Wei Zhang Daniel J. Sargent Sumithra J. Mandrekar	6
+	Meta-analysis for the evaluation of potential surrogate markers	1997	Michael J. Daniels Michael D. Hughes	6
+	Optimising the design of phase II oncology trials: The importance of randomisation	2008	Mark J. Ratain Daniel J. Sargent	6
+ PDF Chat	Comparison of Error Rates in Single-Arm Versus Randomized Phase II Cancer Clinical Trials	2010	Hui Tang Nathan R. Foster Axel Grothey Stephen M. Ansell Richard M. Goldberg Daniel J. Sargent	6
+ PDF Chat	A 2-Stage Phase II Design with Direct Assignment Option in Stage II for Initial Marker Validation	2012	Ming-Wen An Sumithra J. Mandrekar Daniel J. Sargent	6
+ PDF Chat	Adaptive Signature Design: An Adaptive Clinical Trial Design for Generating and Prospectively Testing A Gene Expression Signature for Sensitive Patients	2005	Boris Freidlin Richard Simon	5
+	Randomized Discontinuation Design: Application to Cytostatic Antineoplastic Agents	2002	Gary L. Rosner Walter M. Stadler Mark J. Ratain	5
+ PDF Chat	Randomized Phase II Designs	2009	Larry Rubinstein John Crowley Percy Ivy Michael LeBlanc Daniel J. Sargent	5
+	Bayesian Adaptive Methods for Clinical Trials	2010	Scott Berry Bradley P. Carlin J. Jack Lee Peter Müller	5
+	Comparing an experimental agent to a standard agent: relative merits of a one-arm or randomized two-arm Phase II design	2006	Jeremy M. G. Taylor Thomas M. Braun Zhiguo Li	5
+	Randomized Phase II Trials: What Does Randomization Gain?	2005	H. Samuel Wieand	5
+	A model for association in bivariate life tables and its application in epidemiological studies of familial tendency in chronic disease incidence	1978	David Clayton	5
+ PDF Chat	Clinical Trial Designs for Predictive Biomarker Validation: One Size Does Not Fit All	2009	Sumithra J. Mandrekar Daniel J. Sargent	5
+	Clinical trial methods to discover and validate predictive markers for treatment response in cancer	2003	Soonmyung Paik	5
+ PDF Chat	The Cross-Validated Adaptive Signature Design	2010	Boris Freidlin Wenyu Jiang Richard Simon	5
+	Some practical improvements in the continual reassessment method for phase I studies	1995	Steven N. Goodman Marianna Zahurak Steven Piantadosi	5
+	A Two-Stage Design for Choosing among Several Experimental Treatments and a Control in Clinical Trials	1989	Peter F. Thall Richard Simon Susan S. Ellenberg	5
+ PDF Chat	Blinded Independent Central Review of Progression-Free Survival in Phase III Clinical Trials: Important Design Element or Unnecessary Expense?	2008	Lori E. Dodd Edward L. Korn Boris Freidlin C. Carl Jaffe Larry Rubinstein Janet Dancey Margaret Mooney	5
+	Surrogate Marker Evaluation from an Information Theory Perspective	2006	Ariel Alonso Geert Molenberghs	5
+	Clinical Trial Designs for Prospective Validation of Biomarkers	2005	Sumithra J. Mandrekar Axel Grothey Matthew P. Goetz Daniel J. Sargent	5
+ PDF Chat	Statistical challenges in the evaluation of surrogate endpoints in randomized trials	2002	Geert Molenberghs Marc Buyse Helena Geys Didier Renard Tomasz Burzykowski Ariel Alonso	5
+ PDF Chat	Meta-Analysis of Phase II Cooperative Group Trials in Metastatic Stage IV Melanoma to Determine Progression-Free and Overall Survival Benchmarks for Future Phase II Trials	2008	Edward L. Korn Ping-Yu Liu Sandra J. Lee J. W. Chapman Donna Niedzwiecki Vera J. Suman James Moon Vernon K. Sondak Michael B. Atkins Elizabeth A. Eisenhauer	5
+ PDF Chat	Treatment Success in Cancer<subtitle>New Cancer Treatment Successes Identified in Phase 3 Randomized Controlled Trials Conducted by the National Cancer Institute–Sponsored Cooperative Oncology Groups, 1955 to 2006</subtitle>	2008	Benjamin Djulbegović	5
+	Randomized Phase II Designs in Cancer Clinical Trials: Current Status and Future Directions	2005	J. Jack Lee Lei Feng	4