{"product_id":"clinical-trials-a-methodologic-perspective-wiley-series-in-prob-statistics-see-1345-6-6214-5","title":"Clinical Trials: A Methodologic Perspective (WILEY SERIES IN PROB \u0026 STATISTICS\/see 1345\/6,6214\/5)","description":"\u003cdiv id=\"bookDescription_feature_div\" class=\"celwidget\" data-feature-name=\"bookDescription\" data-csa-c-type=\"widget\" data-csa-c-content-id=\"bookDescription\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-asin=\"0993745598\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-id=\"7y9w7h-rgk3d4-2xixgp-6jetc1\" data-cel-widget=\"bookDescription_feature_div\"\u003e\n\u003cdiv data-a-expander-name=\"book_description_expander\" data-a-expander-collapsed-height=\"280\" class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\"\u003e\n\u003cdiv aria-expanded=\"false\" class=\"a-expander-content a-expander-partial-collapse-content\"\u003e\n\u003cdiv data-cel-widget=\"bookDescription_feature_div\" data-csa-c-id=\"3xu427-hdulpm-xey1d9-kajk0v\" data-csa-c-is-in-initial-active-row=\"false\" data-csa-c-asin=\"1975136373\" data-csa-c-slot-id=\"bookDescription_feature_div\" data-csa-c-content-id=\"bookDescription\" data-csa-c-type=\"widget\" data-feature-name=\"bookDescription\" class=\"celwidget\" id=\"bookDescription_feature_div\"\u003e\n\u003cdiv class=\"a-expander-collapsed-height a-row a-expander-container a-spacing-base a-expander-partial-collapse-container\" data-a-expander-collapsed-height=\"280\" data-a-expander-name=\"book_description_expander\"\u003e\n\u003cdiv class=\"a-expander-content a-expander-partial-collapse-content\" aria-expanded=\"false\"\u003e\n\u003cp\u003e\u003cspan class=\"a-text-bold\"\u003eComprehensive resource presenting methods essential in planning, designing, conducting, analyzing, and interpreting clinical trials\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe Fourth Edition of \u003c\/span\u003e\u003cspan class=\"a-text-italic\"\u003eClinical Trials\u003cspan\u003e \u003c\/span\u003e\u003c\/span\u003e\u003cspan\u003ebuilds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials, discussing principles of design for various types of clinical trials and elements of planning the experiment, assembling a study cohort, assessing data, and reporting results.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eEach chapter contains an introduction and summary to reinforce key points. Discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eWritten by a highly qualified author with significant experience in the field, the Fourth Edition of \u003c\/span\u003e\u003cspan class=\"a-text-italic\"\u003eClinical Trials\u003cspan\u003e \u003c\/span\u003e\u003c\/span\u003e\u003cspan\u003eapproaches the topic with:\u003c\/span\u003e\u003c\/p\u003e\n\u003cul class=\"a-unordered-list a-vertical\"\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eProblems that may arise during a trial, and accompanying common sense solutions\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eDesign alternatives for addressing many questions in therapeutic development\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eStatistical principles with new and provocative topics, such as generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and more\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eAlternative medicine, ethics, middle development, comparative studies, adaptive designs, and clinical trials using point of care data\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cspan class=\"a-list-item\"\u003e\u003cspan\u003eRevamped exercise sets, updated and extensive references, new material on endpoints and the developmental pipeline, and revisions of numerous sections, tables, and figures\u003c\/span\u003e\u003c\/span\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cspan\u003eStanding out due to its accessible and broad coverage of statistical design methods which are the building blocks of clinical trials and medical research, \u003c\/span\u003e\u003cspan class=\"a-text-italic\"\u003eClinical Trials\u003cspan\u003e \u003c\/span\u003e\u003c\/span\u003e\u003cspan\u003eis an essential learning aid on the subject for undergraduate and graduate clinical trials courses.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eAbout the Author\u003cbr\u003eSteven Piantadosi, MD, PhD, is Professor in Residence at Brigham and Women’s Hospital and Harvard Medical School. He is one of the world’s leading experts on the design and analysis of clinical trials. Dr. Piantadosi has been engaged with clinical trials for over 4 decades and taught the subject for more than 30 years. His research has focused on cancer but has involved many other therapeutic areas as well. He has published over 275 papers on research results, clinical applications, and trial methodology. Dr. Piantadosi has held leadership roles with national cooperative oncology groups, including the Alliance, a National Clinical Trials Network collaboration. He has also served as a member of numerous advisory and clinical trial monitoring committees.\u003c\/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003cstrong\u003eTable of Contents\u003c\/strong\u003e\u003cbr\u003ePreface xxi\u003c\/p\u003e\n\u003cp\u003eAbout the Companion website xxv\u003c\/p\u003e\n\u003cp\u003e1 Preliminaries 1\u003c\/p\u003e\n\u003cp\u003e1.1 Introduction 1\u003c\/p\u003e\n\u003cp\u003e1.2 Deconstruction 2\u003c\/p\u003e\n\u003cp\u003e1.3 A Clinical Trial is a Test of Treatment Under Controlled Conditions 3\u003c\/p\u003e\n\u003cp\u003e1.4 Audience 3\u003c\/p\u003e\n\u003cp\u003e1.5 Scope 4\u003c\/p\u003e\n\u003cp\u003e1.6 Other Sources of Knowledge 5\u003c\/p\u003e\n\u003cp\u003e1.8 Programs Examples and Data 8\u003c\/p\u003e\n\u003cp\u003e1.9 Summary 9\u003c\/p\u003e\n\u003cp\u003e2 Clinical Trials as Research 10\u003c\/p\u003e\n\u003cp\u003e2.1 Introduction 10\u003c\/p\u003e\n\u003cp\u003e2.2 Research 12\u003c\/p\u003e\n\u003cp\u003e2.3 Defining Clinical Trials 17\u003c\/p\u003e\n\u003cp\u003e2.4 Practicalities of Usage 24\u003c\/p\u003e\n\u003cp\u003e2.5 Non-Experimental Designs 30\u003c\/p\u003e\n\u003cp\u003e2.6 Summary 34\u003c\/p\u003e\n\u003cp\u003e2.7 Questions for Discussion 34\u003c\/p\u003e\n\u003cp\u003e3 Why Clinical Trials Are Ethical 35\u003c\/p\u003e\n\u003cp\u003e3.1 Introduction 35\u003c\/p\u003e\n\u003cp\u003e3.2 Duality is Ever Present 38\u003c\/p\u003e\n\u003cp\u003e3.3 Historically Derived Principles of Ethics 46\u003c\/p\u003e\n\u003cp\u003e3.4 Contemporary Foundational Principles 52\u003c\/p\u003e\n\u003cp\u003e3.5 Methodologic Reflections 57\u003c\/p\u003e\n\u003cp\u003e3.6 Professional Conduct 62\u003c\/p\u003e\n\u003cp\u003e3.7 Summary 67\u003c\/p\u003e\n\u003cp\u003e3.8 Questions for Discussion 67\u003c\/p\u003e\n\u003cp\u003e4 Contexts for Clinical Trials 69\u003c\/p\u003e\n\u003cp\u003e4.1 Introduction 69\u003c\/p\u003e\n\u003cp\u003e4.2 Drugs 72\u003c\/p\u003e\n\u003cp\u003e4.3 Devices 75\u003c\/p\u003e\n\u003cp\u003e4.4 Prevention 77\u003c\/p\u003e\n\u003cp\u003e4.5 Complementary and Alternative Medicine 83\u003c\/p\u003e\n\u003cp\u003e4.6 Surgery and Skill-Dependent Therapies 90\u003c\/p\u003e\n\u003cp\u003e4.7 A Brief View of Some Other Contexts 100\u003c\/p\u003e\n\u003cp\u003e4.8 Summary 103\u003c\/p\u003e\n\u003cp\u003e4.9 Questions for Discussion 104\u003c\/p\u003e\n\u003cp\u003e5 Measurement 105\u003c\/p\u003e\n\u003cp\u003e5.1 Introduction 105\u003c\/p\u003e\n\u003cp\u003e5.2 Objectives 107\u003c\/p\u003e\n\u003cp\u003e5.3 Measurement Design 109\u003c\/p\u003e\n\u003cp\u003e5.4 Surrogate Outcomes 126\u003c\/p\u003e\n\u003cp\u003e5.5 Summary 132\u003c\/p\u003e\n\u003cp\u003e5.6 Questions for Discussion 132\u003c\/p\u003e\n\u003cp\u003e6 Random Error and Bias 133\u003c\/p\u003e\n\u003cp\u003e6.1 Introduction 133\u003c\/p\u003e\n\u003cp\u003e6.2 Bias in Clinical Trials 140\u003c\/p\u003e\n\u003cp\u003e6.3 Statistical Bias 145\u003c\/p\u003e\n\u003cp\u003e6.4 Summary 149\u003c\/p\u003e\n\u003cp\u003e6.5 Questions for Discussion 150\u003c\/p\u003e\n\u003cp\u003e7 Statistical Perspectives 151\u003c\/p\u003e\n\u003cp\u003e7.1 Introduction 151\u003c\/p\u003e\n\u003cp\u003e7.2 Differences in Statistical Perspectives 152\u003c\/p\u003e\n\u003cp\u003e7.3 Frequentist 155\u003c\/p\u003e\n\u003cp\u003e7.4 Bayesian 157\u003c\/p\u003e\n\u003cp\u003e7.5 Likelihood 161\u003c\/p\u003e\n\u003cp\u003e7.6 Statistics Issues 164\u003c\/p\u003e\n\u003cp\u003e7.7 Summary 165\u003c\/p\u003e\n\u003cp\u003e7.8 Questions for Discussion 166\u003c\/p\u003e\n\u003cp\u003e8 Experiment Design in Clinical Trials 167\u003c\/p\u003e\n\u003cp\u003e8.1 Introduction 167\u003c\/p\u003e\n\u003cp\u003e8.2 Trials as Simple Experiment Designs 168\u003c\/p\u003e\n\u003cp\u003e8.3 Goals of Experiment Design 171\u003c\/p\u003e\n\u003cp\u003e8.4 Design Concepts 173\u003c\/p\u003e\n\u003cp\u003e8.5 Design Features 176\u003c\/p\u003e\n\u003cp\u003e8.6 Special Design Issues 181\u003c\/p\u003e\n\u003cp\u003e8.7 Importance of Protocol Documents 186\u003c\/p\u003e\n\u003cp\u003e8.8 Summary 193\u003c\/p\u003e\n\u003cp\u003e8.9 Questions for Discussion 193\u003c\/p\u003e\n\u003cp\u003e9 Trial Cohorts 195\u003c\/p\u003e\n\u003cp\u003e9.1 Introduction 195\u003c\/p\u003e\n\u003cp\u003e9.2 Cohort Definition and Selection 196\u003c\/p\u003e\n\u003cp\u003e9.3 Modeling Accrual 202\u003c\/p\u003e\n\u003cp\u003e9.4 Inclusiveness Representation and Interactions 205\u003c\/p\u003e\n\u003cp\u003e9.5 Summary 211\u003c\/p\u003e\n\u003cp\u003e9.6 Questions for Discussion 211\u003c\/p\u003e\n\u003cp\u003e10 Development Paradigms 213\u003c\/p\u003e\n\u003cp\u003e10.1 Introduction 213\u003c\/p\u003e\n\u003cp\u003e10.2 Pipeline Principles and Problems 216\u003c\/p\u003e\n\u003cp\u003e10.3 A Simple Quantitative Pipeline 219\u003c\/p\u003e\n\u003cp\u003e10.4 Late Failures 224\u003c\/p\u003e\n\u003cp\u003e10.5 Summary 230\u003c\/p\u003e\n\u003cp\u003e10.6 Questions for Discussion 231\u003c\/p\u003e\n\u003cp\u003e11 Translational Clinical Trials 232\u003c\/p\u003e\n\u003cp\u003e11.1 Introduction 232\u003c\/p\u003e\n\u003cp\u003e11.2 Inferential Paradigms 236\u003c\/p\u003e\n\u003cp\u003e11.3 Evidence and Theory 239\u003c\/p\u003e\n\u003cp\u003e11.4 Translational Trials Defined 241\u003c\/p\u003e\n\u003cp\u003e11.5 Information from Translational Trials 244\u003c\/p\u003e\n\u003cp\u003e11.6 Summary 252\u003c\/p\u003e\n\u003cp\u003e11.7 Questions for Discussion 252\u003c\/p\u003e\n\u003cp\u003e12 Early Development and Dose Finding 253\u003c\/p\u003e\n\u003cp\u003e12.1 Introduction 253\u003c\/p\u003e\n\u003cp\u003e12.2 Essential Concepts 254\u003c\/p\u003e\n\u003cp\u003e12.3 Dose Ranging 260\u003c\/p\u003e\n\u003cp\u003e12.4 Bayesian Optimal Interval (BOIN) Design 266\u003c\/p\u003e\n\u003cp\u003e12.5 Model-Guided Dose Finding 267\u003c\/p\u003e\n\u003cp\u003e12.6 General Dose-Finding Issues 276\u003c\/p\u003e\n\u003cp\u003e12.7 Summary 284\u003c\/p\u003e\n\u003cp\u003e12.8 Questions for Discussion 286\u003c\/p\u003e\n\u003cp\u003e13 Middle Development 287\u003c\/p\u003e\n\u003cp\u003e13.1 Introduction 287\u003c\/p\u003e\n\u003cp\u003e13.2 Characteristics of Middle Development 289\u003c\/p\u003e\n\u003cp\u003e13.3 Design Issues 291\u003c\/p\u003e\n\u003cp\u003e13.4 Middle Development Distills True Positives 293\u003c\/p\u003e\n\u003cp\u003e13.5 Futility and Non-superiority Designs 295\u003c\/p\u003e\n\u003cp\u003e13.6 Dose Efficacy Questions 298\u003c\/p\u003e\n\u003cp\u003e13.7 Randomized Comparisons 299\u003c\/p\u003e\n\u003cp\u003e13.8 Cohort Mixtures 304\u003c\/p\u003e\n\u003cp\u003e13.9 Summary 306\u003c\/p\u003e\n\u003cp\u003e13.10 Questions for Discussion 307\u003c\/p\u003e\n\u003cp\u003e14 Comparative Trials 308\u003c\/p\u003e\n\u003cp\u003e14.1 Introduction 308\u003c\/p\u003e\n\u003cp\u003e14.2 Elements of Reliability 309\u003c\/p\u003e\n\u003cp\u003e14.3 Biomarker-Based Comparative Designs 313\u003c\/p\u003e\n\u003cp\u003e14.4 Other Comparative Designs 317\u003c\/p\u003e\n\u003cp\u003e14.5 Summary 320\u003c\/p\u003e\n\u003cp\u003e14.6 Questions for Discussion 321\u003c\/p\u003e\n\u003cp\u003e15 Adaptive Design Features 322\u003c\/p\u003e\n\u003cp\u003e15.1 Introduction 322\u003c\/p\u003e\n\u003cp\u003e15.2 Some Familiar Adaptations 325\u003c\/p\u003e\n\u003cp\u003e15.3 Biomarker Adaptive Trials 330\u003c\/p\u003e\n\u003cp\u003e15.4 Re-Designs 331\u003c\/p\u003e\n\u003cp\u003e15.5 Seamless Designs 332\u003c\/p\u003e\n\u003cp\u003e15.6 Barriers to AD 333\u003c\/p\u003e\n\u003cp\u003e15.7 Adaptive Design Case Study 333\u003c\/p\u003e\n\u003cp\u003e15.8 Summary 334\u003c\/p\u003e\n\u003cp\u003e15.9 Questions for Discussion 334\u003c\/p\u003e\n\u003cp\u003e16 Precision Sample Size and Power 335\u003c\/p\u003e\n\u003cp\u003e16.1 Introduction 335\u003c\/p\u003e\n\u003cp\u003e16.2 Principles 336\u003c\/p\u003e\n\u003cp\u003e16.3 Early Developmental Trials 339\u003c\/p\u003e\n\u003cp\u003e16.4 Simple Estimation Designs 341\u003c\/p\u003e\n\u003cp\u003e16.5 Event Rates 352\u003c\/p\u003e\n\u003cp\u003e16.6 Stages 355\u003c\/p\u003e\n\u003cp\u003e16.7 Comparative Trials 358\u003c\/p\u003e\n\u003cp\u003e16.8 Expanded Safety Trials 377\u003c\/p\u003e\n\u003cp\u003e16.9 Other Considerations 380\u003c\/p\u003e\n\u003cp\u003e16.10 Summary 386\u003c\/p\u003e\n\u003cp\u003e16.11 Questions for Discussion 387\u003c\/p\u003e\n\u003cp\u003e17 Treatment Allocation 389\u003c\/p\u003e\n\u003cp\u003e17.1 Introduction 389\u003c\/p\u003e\n\u003cp\u003e17.2 Randomization 390\u003c\/p\u003e\n\u003cp\u003e17.3 Constrained Randomization 395\u003c\/p\u003e\n\u003cp\u003e17.4 Adaptive Allocation 398\u003c\/p\u003e\n\u003cp\u003e17.5 Other Issues Regarding Randomization 401\u003c\/p\u003e\n\u003cp\u003e17.6 Unequal Treatment Allocation 406\u003c\/p\u003e\n\u003cp\u003e17.7 Randomization Before Consent 410\u003c\/p\u003e\n\u003cp\u003e17.8 Summary 410\u003c\/p\u003e\n\u003cp\u003e17.9 Questions for Discussion 411\u003c\/p\u003e\n\u003cp\u003e18 Monitoring Treatment Effects 412\u003c\/p\u003e\n\u003cp\u003e18.1 Introduction 412\u003c\/p\u003e\n\u003cp\u003e18.2 Administrative Issues in Trial Monitoring 415\u003c\/p\u003e\n\u003cp\u003e18.3 Organizational Issues Related to Monitoring 422\u003c\/p\u003e\n\u003cp\u003e18.4 Statistical Methods for Monitoring 428\u003c\/p\u003e\n\u003cp\u003e18.5 Summary 447\u003c\/p\u003e\n\u003cp\u003e18.6 Questions for Discussion 448\u003c\/p\u003e\n\u003cp\u003e19 Counting Subjects and Events 450\u003c\/p\u003e\n\u003cp\u003e19.1 Introduction 450\u003c\/p\u003e\n\u003cp\u003e19.2 Imperfection and Validity 451\u003c\/p\u003e\n\u003cp\u003e19.3 Treatment Nonadherence 452\u003c\/p\u003e\n\u003cp\u003e19.4 Protocol Nonadherence 455\u003c\/p\u003e\n\u003cp\u003e19.5 Data Imperfections 457\u003c\/p\u003e\n\u003cp\u003e19.6 Summary 461\u003c\/p\u003e\n\u003cp\u003e19.7 Questions for Discussion 461\u003c\/p\u003e\n\u003cp\u003e20 Estimating Clinical Effects 462\u003c\/p\u003e\n\u003cp\u003e20.1 Introduction 462\u003c\/p\u003e\n\u003cp\u003e20.2 Dose-Finding and Pharmacokinetic Trials 465\u003c\/p\u003e\n\u003cp\u003e20.3 Middle Development Studies 470\u003c\/p\u003e\n\u003cp\u003e20.4 Randomized Comparative Trials 475\u003c\/p\u003e\n\u003cp\u003e20.5 Problems With P-Values 483\u003c\/p\u003e\n\u003cp\u003e20.6 Strength of Evidence Through Support Intervals 487\u003c\/p\u003e\n\u003cp\u003e20.7 Special Methods of Analysis 488\u003c\/p\u003e\n\u003cp\u003e20.8 Vaccine Trials 494\u003c\/p\u003e\n\u003cp\u003e20.9 Exploratory Analyses 496\u003c\/p\u003e\n\u003cp\u003e20.10 Summary 504\u003c\/p\u003e\n\u003cp\u003e20.11 Questions for Discussion 504\u003c\/p\u003e\n\u003cp\u003e21 Generalizing Results From Clinical Trials 508\u003c\/p\u003e\n\u003cp\u003e21.1 Introduction 508\u003c\/p\u003e\n\u003cp\u003e21.2 Laboratory Lessons 510\u003c\/p\u003e\n\u003cp\u003e21.3 Sample-Based Generalization 510\u003c\/p\u003e\n\u003cp\u003e21.4 Reconciling New Findings with Old Data 512\u003c\/p\u003e\n\u003cp\u003e21.5 Fit for Purpose Data 513\u003c\/p\u003e\n\u003cp\u003e21.6 Shared Biology 514\u003c\/p\u003e\n\u003cp\u003e21.7 Learning from Harmful Effects 515\u003c\/p\u003e\n\u003cp\u003e21.8 Pandemic 516\u003c\/p\u003e\n\u003cp\u003e21.9 Summary 517\u003c\/p\u003e\n\u003cp\u003e21.10 Questions for Discussion 517\u003c\/p\u003e\n\u003cp\u003e22 Prognostic Factor Analyses 518\u003c\/p\u003e\n\u003cp\u003e22.1 Introduction 518\u003c\/p\u003e\n\u003cp\u003e22.2 Model-Based Methods 520\u003c\/p\u003e\n\u003cp\u003e22.3 Adjusted Analyses of Comparative Trials 531\u003c\/p\u003e\n\u003cp\u003e22.4 Pfas Without Models 534\u003c\/p\u003e\n\u003cp\u003e22.5 Summary 538\u003c\/p\u003e\n\u003cp\u003e22.6 Questions for Discussion 538\u003c\/p\u003e\n\u003cp\u003e23 Factorial Designs 539\u003c\/p\u003e\n\u003cp\u003e23.1 Introduction 539\u003c\/p\u003e\n\u003cp\u003e23.2 Characteristics of Factorial Designs 540\u003c\/p\u003e\n\u003cp\u003e23.3 Treatment Interactions 542\u003c\/p\u003e\n\u003cp\u003e23.4 Examples of Factorial Designs 546\u003c\/p\u003e\n\u003cp\u003e23.5 Partial Fractional and Incomplete Factorials 547\u003c\/p\u003e\n\u003cp\u003e23.6 Summary 548\u003c\/p\u003e\n\u003cp\u003e23.7 Questions for Discussion 548\u003c\/p\u003e\n\u003cp\u003e24 Crossover Designs 550\u003c\/p\u003e\n\u003cp\u003e24.1 Introduction 550\u003c\/p\u003e\n\u003cp\u003e24.2 Advantages and Disadvantages 552\u003c\/p\u003e\n\u003cp\u003e24.3 Analysis 555\u003c\/p\u003e\n\u003cp\u003e24.4 Crossover Case Study 559\u003c\/p\u003e\n\u003cp\u003e24.5 Summary 559\u003c\/p\u003e\n\u003cp\u003e24.6 Questions for Discussion 560\u003c\/p\u003e\n\u003cp\u003e25 Operating Characteristics 561\u003c\/p\u003e\n\u003cp\u003e25.1 Introduction 561\u003c\/p\u003e\n\u003cp\u003e25.2 Calculated Operating Characteristics 562\u003c\/p\u003e\n\u003cp\u003e25.3 Operating Characteristics by Simulation 565\u003c\/p\u003e\n\u003cp\u003e25.4 Summary 571\u003c\/p\u003e\n\u003cp\u003e25.5 Questions for Discussion 572\u003c\/p\u003e\n\u003cp\u003e26 Meta-Analyses 573\u003c\/p\u003e\n\u003cp\u003e26.1 Introduction 573\u003c\/p\u003e\n\u003cp\u003e26.2 A Sketch of Meta-Analysis Methods 575\u003c\/p\u003e\n\u003cp\u003e26.3 Other Issues 579\u003c\/p\u003e\n\u003cp\u003e26.4 Summary 580\u003c\/p\u003e\n\u003cp\u003e26.5 Questions for Discussion 580\u003c\/p\u003e\n\u003cp\u003e27 Reporting and Authorship 581\u003c\/p\u003e\n\u003cp\u003e27.1 Introduction 581\u003c\/p\u003e\n\u003cp\u003e27.2 General Issues in Reporting 582\u003c\/p\u003e\n\u003cp\u003e27.3 Clinical Trial Reports 585\u003c\/p\u003e\n\u003cp\u003e27.4 Authorship 593\u003c\/p\u003e\n\u003cp\u003e27.5 Other Issues in Disseminating Results 596\u003c\/p\u003e\n\u003cp\u003e27.6 Summary 597\u003c\/p\u003e\n\u003cp\u003e27.7 Questions for Discussion 598\u003c\/p\u003e\n\u003cp\u003e28 Misconduct and Fraud in Clinical Research 599\u003c\/p\u003e\n\u003cp\u003e28.1 Introduction 599\u003c\/p\u003e\n\u003cp\u003e28.2 Research Practices 604\u003c\/p\u003e\n\u003cp\u003e28.3 Approach to Allegations of Misconduct 606\u003c\/p\u003e\n\u003cp\u003e28.4 Characteristics of Some Misconduct Cases 608\u003c\/p\u003e\n\u003cp\u003e28.5 Lessons 615\u003c\/p\u003e\n\u003cp\u003e28.6 Clinical Investigator Responsibilities 616\u003c\/p\u003e\n\u003cp\u003e28.7 Summary 618\u003c\/p\u003e\n\u003cp\u003e28.8 Questions for Discussion 619\u003c\/p\u003e\n\u003cp\u003e29 Clinical Trials in the COVID-19 Pandemic 620\u003c\/p\u003e\n\u003cp\u003e29.1 Introduction 620\u003c\/p\u003e\n\u003cp\u003e29.2 Epidemic Models 622\u003c\/p\u003e\n\u003cp\u003e29.3 Testing 624\u003c\/p\u003e\n\u003cp\u003e29.4 Useless Well-Liked Drugs 626\u003c\/p\u003e\n\u003cp\u003e29.5 Impact of Covid-19 on Clinical Trials 627\u003c\/p\u003e\n\u003cp\u003e29.6 Designing Trials to Test Covid-19 Treatments 628\u003c\/p\u003e\n\u003cp\u003e29.7 Ethics Takes a Detour 631\u003c\/p\u003e\n\u003cp\u003e29.8 Vaccine Trials 637\u003c\/p\u003e\n\u003cp\u003e29.9 Summary 641\u003c\/p\u003e\n\u003cp\u003e29.10 Questions for Discussion 641\u003c\/p\u003e\n\u003cp\u003e30 Real-World Clinical Trials 642\u003c\/p\u003e\n\u003cp\u003e30.1 Introduction 642\u003c\/p\u003e\n\u003cp\u003e30.2 Point-of-Care Data 643\u003c\/p\u003e\n\u003cp\u003e30.3 Whither Clinical Trials? 646\u003c\/p\u003e\n\u003cp\u003e30.4 Summary 647\u003c\/p\u003e\n\u003cp\u003e30.5 Questions for Discussion 647\u003c\/p\u003e\n\u003cp\u003eAppendix A Notation and Terminology 648\u003c\/p\u003e\n\u003cp\u003eReferences 662\u003c\/p\u003e\n\u003cp\u003eIndex 741\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cb\u003eBOOKREAD™ 5-STEP SATISFACTION GUARANTEE\u003c\/b\u003e\u003c\/strong\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003e1. No 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