{"product_id":"randomised-clinical-trials-isbn-9781119524649","title":"Randomised Clinical Trials","description":"\u003cp\u003e\u003ci\u003eRandomised Clinical Trials: Design, Practice and Reporting\u003c\/i\u003e provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process.\u003c\/p\u003e \u003cp\u003eThis \u003ci\u003esecond edition\u003c\/i\u003e contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eProvides comprehensive coverage of randomised clinical trials, ranging from basic to advanced\u003c\/li\u003e \u003cli\u003eFeatures several new chapters, updated case studies and examples, and references to changes in regulations\u003c\/li\u003e \u003cli\u003eExplains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure\u003c\/li\u003e \u003cli\u003eCovers paired trial designs and trials with more than two interventions\u003c\/li\u003e \u003cli\u003eIncludes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eRandomised Clinical Trials\u003c\/i\u003e is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.\u003c\/p\u003e \u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Basic Considerations 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction 3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 3\u003c\/p\u003e \u003cp\u003e1.2 Some completed trials 4\u003c\/p\u003e \u003cp\u003e1.3 Choice of design 13\u003c\/p\u003e \u003cp\u003e1.4 Practical constraints 18\u003c\/p\u003e \u003cp\u003e1.5 Influencing clinical practice 20\u003c\/p\u003e \u003cp\u003e1.6 History 20\u003c\/p\u003e \u003cp\u003e1.7 How do trials arise? 22\u003c\/p\u003e \u003cp\u003e1.8 Ethical considerations 24\u003c\/p\u003e \u003cp\u003e1.9 Regulatory requirements 24\u003c\/p\u003e \u003cp\u003e1.10 Focus 25\u003c\/p\u003e \u003cp\u003e1.11 Further reading 25\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Design Features 27\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 27\u003c\/p\u003e \u003cp\u003e2.2 The research question 29\u003c\/p\u003e \u003cp\u003e2.3 Patient selection 30\u003c\/p\u003e \u003cp\u003e2.4 The consent process 32\u003c\/p\u003e \u003cp\u003e2.5 Choice of interventions 33\u003c\/p\u003e \u003cp\u003e2.6 Choice of design 35\u003c\/p\u003e \u003cp\u003e2.7 Assigning the interventions 37\u003c\/p\u003e \u003cp\u003e2.8 Making the assessments 38\u003c\/p\u003e \u003cp\u003e2.9 Analysis and reporting 38\u003c\/p\u003e \u003cp\u003e2.10 Technical details 42\u003c\/p\u003e \u003cp\u003e2.11 Guidelines 43\u003c\/p\u003e \u003cp\u003e2.12 Further reading 44\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 The Trial Protocol 45\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 45\u003c\/p\u003e \u003cp\u003e3.2 Abstract 47\u003c\/p\u003e \u003cp\u003e3.3 Background 49\u003c\/p\u003e \u003cp\u003e3.4 Research objectives 49\u003c\/p\u003e \u003cp\u003e3.5 Design 52\u003c\/p\u003e \u003cp\u003e3.6 Intervention details 53\u003c\/p\u003e \u003cp\u003e3.7 Eligibility 56\u003c\/p\u003e \u003cp\u003e3.8 Randomisation 58\u003c\/p\u003e \u003cp\u003e3.9 Assessment and data collection 61\u003c\/p\u003e \u003cp\u003e3.10 Statistical considerations 63\u003c\/p\u003e \u003cp\u003e3.11 Ethical issues 66\u003c\/p\u003e \u003cp\u003e3.12 Organisational structure 69\u003c\/p\u003e \u003cp\u003e3.13 Publication policy 69\u003c\/p\u003e \u003cp\u003e3.14 Trial forms 70\u003c\/p\u003e \u003cp\u003e3.15 Appendices 71\u003c\/p\u003e \u003cp\u003e3.16 Regulatory requirements 72\u003c\/p\u003e \u003cp\u003e3.17 Guidelines 74\u003c\/p\u003e \u003cp\u003e3.18 Protocols 74\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Measurement and Data Capture 77\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 77\u003c\/p\u003e \u003cp\u003e4.2 Types of measures 78\u003c\/p\u003e \u003cp\u003e4.3 Measures and endpoints 80\u003c\/p\u003e \u003cp\u003e4.4 Making the observations 91\u003c\/p\u003e \u003cp\u003e4.5 Baseline measures 92\u003c\/p\u003e \u003cp\u003e4.6 Data recording 93\u003c\/p\u003e \u003cp\u003e4.7 Technical notes 101\u003c\/p\u003e \u003cp\u003e4.8 Guidelines 101\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Randomisation 103\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 103\u003c\/p\u003e \u003cp\u003e5.2 Rationale 104\u003c\/p\u003e \u003cp\u003e5.3 Mechanics 104\u003c\/p\u003e \u003cp\u003e5.4 Application 113\u003c\/p\u003e \u003cp\u003e5.5 Carrying out randomisation 115\u003c\/p\u003e \u003cp\u003e5.6 Documentation 119\u003c\/p\u003e \u003cp\u003e5.7 Unacceptable methods 120\u003c\/p\u003e \u003cp\u003e5.8 Guidelines 120\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Trial Initiation 121\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 121\u003c\/p\u003e \u003cp\u003e6.2 Trial organisation 122\u003c\/p\u003e \u003cp\u003e6.3 Data collection and processing 130\u003c\/p\u003e \u003cp\u003e6.4 Internal data monitoring 132\u003c\/p\u003e \u003cp\u003e6.5 Ethical and regulatory requirements 133\u003c\/p\u003e \u003cp\u003e6.6 Launching the trial 134\u003c\/p\u003e \u003cp\u003e6.7 Trial registries 134\u003c\/p\u003e \u003cp\u003e6.8 Guidelines 135\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Trial Conduct and Completion 137\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 137\u003c\/p\u003e \u003cp\u003e7.2 Regular feedback 137\u003c\/p\u003e \u003cp\u003e7.3 Publicity 141\u003c\/p\u003e \u003cp\u003e7.4 Protocol modifications 142\u003c\/p\u003e \u003cp\u003e7.5 Preparing the publication(s) 142\u003c\/p\u003e \u003cp\u003e7.6 The next trial? 145\u003c\/p\u003e \u003cp\u003e7.7 Protocol 146\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Basics for Analysis 147\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 147\u003c\/p\u003e \u003cp\u003e8.2 The standard Normal distribution 148\u003c\/p\u003e \u003cp\u003e8.3 Confidence intervals 149\u003c\/p\u003e \u003cp\u003e8.4 Statistical tests 150\u003c\/p\u003e \u003cp\u003e8.5 Examples of analysis 152\u003c\/p\u003e \u003cp\u003e8.6 Regression methods 169\u003c\/p\u003e \u003cp\u003e8.7 Other issues 179\u003c\/p\u003e \u003cp\u003e8.8 Practice 182\u003c\/p\u003e \u003cp\u003e8.9 Technical details 183\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Trial Size 185\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 185\u003c\/p\u003e \u003cp\u003e9.2 Significance level and power 186\u003c\/p\u003e \u003cp\u003e9.3 The fundamental equation 188\u003c\/p\u003e \u003cp\u003e9.4 Specific situations 190\u003c\/p\u003e \u003cp\u003e9.5 Practical considerations 198\u003c\/p\u003e \u003cp\u003e9.6 Further topics 203\u003c\/p\u003e \u003cp\u003e9.7 Guideline 206\u003c\/p\u003e \u003cp\u003e9.8 Software 206\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Data and Safety Monitoring 209\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 209\u003c\/p\u003e \u003cp\u003e10.2 The DSMB 211\u003c\/p\u003e \u003cp\u003e10.3 Early reviews 214\u003c\/p\u003e \u003cp\u003e10.4 Interim reviews 219\u003c\/p\u003e \u003cp\u003e10.5 Protocols 228\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Reporting 229\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 229\u003c\/p\u003e \u003cp\u003e11.2 Publication 230\u003c\/p\u003e \u003cp\u003e11.3 Responsibilities 233\u003c\/p\u003e \u003cp\u003e11.4 Background 235\u003c\/p\u003e \u003cp\u003e11.5 Methods 236\u003c\/p\u003e \u003cp\u003e11.6 Findings 248\u003c\/p\u003e \u003cp\u003e11.7 When things go wrong 258\u003c\/p\u003e \u003cp\u003e11.8 Conclusions 259\u003c\/p\u003e \u003cp\u003e11.9 Guidelines 260\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Adaptions of the Basic Design 263\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 More Than Two Interventions 265\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 265\u003c\/p\u003e \u003cp\u003e12.2 Unstructured comparisons 266\u003c\/p\u003e \u003cp\u003e12.3 Comparisons with placebo (or standard) 270\u003c\/p\u003e \u003cp\u003e12.4 Dose-response designs 275\u003c\/p\u003e \u003cp\u003e12.5 Factorial trials 280\u003c\/p\u003e \u003cp\u003e12.6 Complex structure comparisons 289\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Paired and Matched Designs 293\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Matched-pair trials 293\u003c\/p\u003e \u003cp\u003e13.2 Cross-over trials 305\u003c\/p\u003e \u003cp\u003e13.3 Split-mouth designs 311\u003c\/p\u003e \u003cp\u003e13.4 Guidelines 317\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Repeated Measures Design 319\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 319\u003c\/p\u003e \u003cp\u003e14.2 Simplified analysis 322\u003c\/p\u003e \u003cp\u003e14.3 Regression models 329\u003c\/p\u003e \u003cp\u003e14.4 Auto-correlation 331\u003c\/p\u003e \u003cp\u003e14.5 Accounting for auto-correlation 334\u003c\/p\u003e \u003cp\u003e14.6 The design effect (DE) 338\u003c\/p\u003e \u003cp\u003e14.7 Trial size 344\u003c\/p\u003e \u003cp\u003e14.8 Practicalities 347\u003c\/p\u003e \u003cp\u003e14.9 Reporting 350\u003c\/p\u003e \u003cp\u003e14.10 Matched organs receiving the same intervention 354\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Non-Inferiority and Equivalence Trials 357\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 357\u003c\/p\u003e \u003cp\u003e15.2 Non-inferiority 358\u003c\/p\u003e \u003cp\u003e15.3 Analysis 361\u003c\/p\u003e \u003cp\u003e15.4 Trial size 366\u003c\/p\u003e \u003cp\u003e15.5 Equivalence 370\u003c\/p\u003e \u003cp\u003e15.6 Reporting 373\u003c\/p\u003e \u003cp\u003e15.7 Practical Issues 373\u003c\/p\u003e \u003cp\u003e15.8 Guidelines 373\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Cluster Designs 375\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16.1 Design features 375\u003c\/p\u003e \u003cp\u003e16.2 Procedures 376\u003c\/p\u003e \u003cp\u003e16.3 Regression models 379\u003c\/p\u003e \u003cp\u003e16.4 Intra-class correlation 380\u003c\/p\u003e \u003cp\u003e16.5 Trial size 381\u003c\/p\u003e \u003cp\u003e16.6 Analysis 386\u003c\/p\u003e \u003cp\u003e16.7 Practicalities 388\u003c\/p\u003e \u003cp\u003e16.8 Reporting 388\u003c\/p\u003e \u003cp\u003e16.9 Further reading 389\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Stepped Wedge Designs 391\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 391\u003c\/p\u003e \u003cp\u003e17.2 Notation 392\u003c\/p\u003e \u003cp\u003e17.3 Basic structure 396\u003c\/p\u003e \u003cp\u003e17.4 Randomisation 398\u003c\/p\u003e \u003cp\u003e17.5 Cross-sectional design 398\u003c\/p\u003e \u003cp\u003e17.6 Closed cohort design 408\u003c\/p\u003e \u003cp\u003e17.7 Practicalities 413\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Further Topics 415\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Genomic Targets 417\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 417\u003c\/p\u003e \u003cp\u003e18.2 Predictive markers 418\u003c\/p\u003e \u003cp\u003e18.3 Enrichment design 420\u003c\/p\u003e \u003cp\u003e18.4 Biomarker-Stratified Designs 422\u003c\/p\u003e \u003cp\u003e18.5 Adaptive threshold designs 431\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Feasibility and Pilot Studies 435\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction 435\u003c\/p\u003e \u003cp\u003e19.2 Feasibility studies 436\u003c\/p\u003e \u003cp\u003e19.3 External-pilot studies 437\u003c\/p\u003e \u003cp\u003e19.4 Considerations across external-pilot and main trial 444\u003c\/p\u003e \u003cp\u003e19.5 Internal-pilot studies 445\u003c\/p\u003e \u003cp\u003e19.6 Other preliminary studies 447\u003c\/p\u003e \u003cp\u003e19.7 Reporting 449\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Further Topics 451\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction 451\u003c\/p\u003e \u003cp\u003e20.2 Adaptive approaches 452\u003c\/p\u003e \u003cp\u003e20.3 Large simple trials 461\u003c\/p\u003e \u003cp\u003e20.4 Bayesian methods 463\u003c\/p\u003e \u003cp\u003e20.5 Interim analyses 467\u003c\/p\u003e \u003cp\u003e20.6 Zelen randomised consent designs 472\u003c\/p\u003e \u003cp\u003e20.7 Systematic overviews 476\u003c\/p\u003e \u003cp\u003eStatistical Tables 483\u003c\/p\u003e \u003cp\u003eGlossary 493\u003c\/p\u003e \u003cp\u003eReferences 503\u003c\/p\u003e \u003cp\u003eIndex 523\u003c\/p\u003e \u003cp\u003e\u003cb\u003eDavid Machin\u003c\/b\u003e, Leicester Cancer Research Group, University of Leicester, UK; and Medical Statistics Group, School of Health and Related Research, University of Sheffield, UK.\u003c\/p\u003e\u003cp\u003e\u003cb\u003ePeter M. Fayers\u003c\/b\u003e, Institute of Applied Health, University of Aberdeen, UK.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eBee Choo Tai\u003c\/b\u003e, Saw Swee Hock School of Public Health, National University of Singapore, and National University Health System, Singapore; and Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, Singapore. \u003c\/p\u003e  \u003cp\u003e\u003ci\u003eRandomised Clinical Trials: Design, Practice and Reporting\u003c\/i\u003e provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process. \u003c\/p\u003e\u003cp\u003eThis second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book:\u003c\/p\u003e\u003cli\u003e\u003cbl\u003eProvides comprehensive coverage of randomised clinical trials, ranging from basic to advanced\u003c\/bl\u003e\u003c\/li\u003e\u003cli\u003e\u003cbl\u003eFeatures several new chapters, updated case studies and examples, and references to changes in regulations\u003c\/bl\u003e\u003c\/li\u003e\u003cli\u003e\u003cbl\u003eExplains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure\u003c\/bl\u003e\u003c\/li\u003e\u003cli\u003e\u003cbl\u003eCovers paired trial designs and trials with more than two interventions\u003c\/bl\u003e\u003c\/li\u003e\u003cli\u003e\u003cbl\u003eIncludes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test\u003c\/bl\u003e\u003c\/li\u003e\u003cp\u003e\u003ci\u003eRandomised Clinical Trials\u003c\/i\u003e is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":47989911847141,"sku":"NP9781119524649","price":107.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119524649.jpg?v=1761785880","url":"https:\/\/k12savings.com\/es\/products\/randomised-clinical-trials-isbn-9781119524649","provider":"K12savings","version":"1.0","type":"link"}