Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis (Chapman & Hall/CRC Biostatistics Series)

Cancer Clinical Trials: Current And Controversial Issues In Design And Analysis Provides Statisticians With An Understanding Of The Critical Challenges Currently Encountered In Oncology Trials. Well-known Statisticians From Academic Institutions, Regulatory And Government Agencies (such As The U.s. Fda And National Cancer Institute), And The Pharmaceutical Industry Share Their Extensive Experiences In Cancer Clinical Trials And Present Examples Taken From Actual Trials. The Book Covers Topics That Are Often Perplexing And Sometimes Controversial In Cancer Clinical Trials. Most Of The Issues Addressed Are Also Important For Clinical Trials In Other Settings. After Discussing General Topics, The Book Focuses On Aspects Of Early And Late Phase Clinical Trials. It Also Explores Personalized Medicine, Including Biomarker-based Clinical Trials, Adaptive Clinical Trial Designs, And Dynamic Treatment Regimes.--- Features: *presents State-of-the-art Approaches To The Design And Analysis Of Cancer Clinical Trials, Such As Adaptive Designs, Biomarker-based Trials, And Dynamic Treatment Regimes; *explains The Importance Of Selection Of Endpoints, Use Of Historical Data, Multiplicity, Analysis Of Safety Data, Discovery And Validation Of Predictive Signatures, Dose-finding, Sample Size, And Non-inferiority Designs; *includes Contributions From Top Researchers In Academia, Government, And The Industry; *contains Many Examples Drawn From Real Cancer Clinical Trials --- Text From Back Of Book Preface -- Editors -- I General Issues -- 1 Endpoints For Cancer Clinical Trials -- 2 Use Of Historical Data -- 3 Multiplicity -- 4 Analysis Of Safety Data -- Ii Early Phase Clinical Trials -- 5 Development And Validation Of Predictive Signatures -- 6 Phase I Trials And Dose-finding -- 7 Design And Analysis Of Phase Ii Cancer Clinical Trials -- Iii Late Phase Clinical Trials -- 8 Sample Size For Survival Trials In Cancer -- 9 Non-inferiority Trials -- 10 Quality Of Life -- Iv Personalized Medicine -- 11 Biomarker-based Clinical Trials -- 12 Adaptive Clinical Trial Designs In Oncology -- 13 Dynamic Treatment Regimes -- Index Edited By Stephen L. George, Xiaofei Wang, Herbert Pang. Includes Bibliographical References And Index. "Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.-- Features: *Presents state-of-the-art approaches to the design and analysis of cancer clinical trials, such as adaptive designs, biomarker-based trials, and dynamic treatment regimes; *Explains the importance of selection of endpoints, use of historical data, multiplicity, analysis of safety data, discovery and validation of predictive signatures, dose-finding, sample size, and non-inferiority designs; *Includes contributions from top researchers in academia, government, and the industry; *Contains many examples drawn from real cancer clinical trials" -- Provided by publisher Content: General Issues Endpoints for Cancer Clinical Trials Stephen L. George, Xiaofei Wang, and Herbert PangUse of Historical Data Simon Wandel, Heinz Schmidli, and Beat NeuenschwanderMultiplicity Dong Xi, Ekkehard Glimm, and Frank BretzAnalysis of Safety Data Steven Snapinn and Qi JiangEarly Phase Clinical Trials Development and Validation of Predictive Signatures Michael C. Sachs and Lisa M. McShanePhase I Trials and Dose-Finding Mark R. Conaway and Nolan A. WagesDesign and Analysis of Phase II Cancer Clinical Trials Sin-Ho JungLate Phase Clinical TrialsSample Size for Survival Trials in CancerEdward LakatosNon-Inferiority Trials Rajeshwari Sridhara and Thomas GwiseQuality of Life Diane FaircloughPersonalized Medicine Biomarker-Based Clinical Trials Edward L. Korn and Boris FreidlinAdaptive Clinical Trial Designs in Oncology J. Jack Lee and Lorenzo TrippaDynamic Treatment Regimes Marie Davidian, Anastasios (Butch) Tsiatis, and Eric LaberIndex This book provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. The book covers state-of-the-art approaches to the design and analysis of cancer clinical trials, such as adaptive designs, biomarker-based trials, and dynamic treatment regimes.