Principles and Practice of Clinical Trials

Table of Contents

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   Book Overview
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   Chapter 29 Investigator Responsibilities
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   Chapter 30 Centers Participating in Multicenter Trials
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   Chapter 32 Principles of Protocol Development
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   Chapter 34 Procurement and Distribution of Study Medicines
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   Chapter 35 Selection of Study Centers and Investigators
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   Chapter 36 Design and Development of the Study Data System
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   Chapter 37 Implementing the Trial Protocol
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   Chapter 38 Participant Recruitment, Screening, and Enrollment
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    Chapter 39 Administration of Study Treatments and Participant Follow-Up
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    Chapter 40 Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials
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    Chapter 41 End of Trial and Close Out of Data Collection
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    Chapter 44 International Trials
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    Chapter 45 Documentation: Essential Documents and Standard Operating Procedures
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    Chapter 46 Consent Forms and Procedures
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    Chapter 47 Contracts and Budgets
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    Chapter 51 Regulatory Requirements in Clinical Trials
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    Chapter 55 Funding Models and Proposals
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    Chapter 56 Trial Organization and Governance
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    Chapter 57 Advocacy and Patient Involvement in Clinical Trials
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    Chapter 61 Efficient Management of a Publicly Funded Cancer Clinical Trials Portfolio
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    Chapter 62 Archiving Records and Materials
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    Chapter 64 Good Clinical Practice
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    Chapter 65 Institutional Review Boards and Ethics Committees
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    Chapter 69 Use of Historical Data in Design
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    Chapter 70 Outcomes in Clinical Trials
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    Chapter 76 Translational Clinical Trials
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    Chapter 77 Dose-Finding and Dose-Ranging Studies
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    Chapter 80 Dose Finding for Drug Combinations
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    Chapter 81 Middle Development Trials
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    Chapter 82 Randomized Selection Designs
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    Chapter 83 Futility Designs
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    Chapter 84 Interim Analysis in Clinical Trials
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    Chapter 92 Bayesian Adaptive Designs for Phase I Trials
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    Chapter 93 Designs to Detect Disease Modification
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    Chapter 95 Screening Trials
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    Chapter 96 Prevention Trials: Challenges in Design, Analysis, and Interpretation of Prevention Trials
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    Chapter 97 N-of-1 Randomized Trials
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    Chapter 98 Noninferiority Trials
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    Chapter 100 Factorial Trials
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    Chapter 101 Within Person Randomized Trials
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    Chapter 102 Device Trials
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    Chapter 104 Randomized Discontinuation Trials
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    Chapter 107 Platform Trial Designs
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    Chapter 108 Cluster Randomized Trials
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    Chapter 110 Multi-arm Multi-stage (MAMS) Platform Randomized Clinical Trials
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    Chapter 112 Preview of Counting and Analysis Principles
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    Chapter 113 Intention to Treat and Alternative Approaches
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    Chapter 114 Estimation and Hypothesis Testing
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    Chapter 115 Estimands and Sensitivity Analyses
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    Chapter 116 Confident Statistical Inference with Multiple Outcomes, Subgroups, and Other Issues of Multiplicity
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    Chapter 117 Missing Data
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    Chapter 118 Essential Statistical Tests
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    Chapter 119 Nonparametric Survival Analysis
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    Chapter 120 Survival Analysis II
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    Chapter 121 Prognostic Factor Analyses
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    Chapter 122 Logistic Regression and Related Methods
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    Chapter 123 Statistical Analysis of Patient-Reported Outcomes in Clinical Trials
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    Chapter 124 Adherence Adjusted Estimates in Randomized Clinical Trials
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    Chapter 129 Randomization and Permutation Tests
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    Chapter 130 Use of Resampling Procedures to Investigate Issues of Model Building and Its Stability
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    Chapter 131 Joint Analysis of Longitudinal and Time-to-Event Data
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    Chapter 136 Safety and Risk Benefit Analyses
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    Chapter 137 Causal Inference: Efficacy and Mechanism Evaluation
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    Chapter 138 Development and Validation of Risk Prediction Models
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    Chapter 161 Leveraging “Big Data” for the Design and Execution of Clinical Trials
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    Chapter 162 Trials in Complementary and Integrative Health Interventions
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    Chapter 163 Fraud in Clinical Trials
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    Chapter 164 Clinical Trials on Trial: Lawsuits Stemming from Clinical Research
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    Chapter 168 Biomarker-Guided Trials
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    Chapter 171 Trials in Minority Populations
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    Chapter 172 Expanded Access to Drug and Device Products for Clinical Treatment
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    Chapter 175 A Perspective on the Process of Designing and Conducting Clinical Trials
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    Chapter 182 Paper Writing
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    Chapter 183 Reporting Biases
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    Chapter 184 Publications from Clinical Trials
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    Chapter 187 Study Name, Authorship, Titling, and Credits
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    Chapter 188 CONSORT and Its Extensions for Reporting Clinical Trials
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    Chapter 190 Data Sharing and Reuse
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    Chapter 191 De-identifying Clinical Trial Data
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    Chapter 194 Introduction to Systematic Reviews
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    Chapter 195 Reading and Interpreting the Literature on Randomized Controlled Trials
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    Chapter 196 Social and Scientific History of Randomized Controlled Trials
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    Chapter 198 Evolution of Clinical Trials Science
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    Chapter 200 Terminology: Conventions and Recommendations
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    Chapter 208 History of the Society for Clinical Trials
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    Chapter 209 Data and Safety Monitoring and Reporting
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    Chapter 210 Controlling for Multiplicity, Eligibility, and Exclusions
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    Chapter 211 Principles of Clinical Trials: Bias and Precision Control
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    Chapter 213 Power and Sample Size
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    Chapter 214 Controlling Bias in Randomized Clinical Trials
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    Chapter 215 Masking of Trial Investigators
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    Chapter 216 Masking Study Participants
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    Chapter 217 Issues for Masked Data Monitoring
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    Chapter 218 Variance Control Procedures
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    Chapter 219 Bias Control in Randomized Controlled Clinical Trials
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    Chapter 233 Ascertainment and Classification of Outcomes
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    Chapter 236 Issues in Generalizing Results from Clinical Trials
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    Chapter 238 Clinical Trials, Ethics, and Human Protections Policies
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     Chapter 240 Training the Investigatorship
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     Chapter 241 Patient-Reported Outcomes
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     Chapter 243 Cross-over Trials
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     Chapter 245 Complex Intervention Trials
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     Chapter 251 Monte Carlo Simulation for Trial Design Tool
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     Chapter 253 Orphan Drugs and Rare Diseases
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     Chapter 256 Post-Approval Regulatory Requirements
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     Chapter 259 Clinical Trials in Children
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     Chapter 260 Trials in Older Adults
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     Chapter 266 ClinicalTrials.gov
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     Chapter 267 Financial Compliance in Clinical Trials
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     Chapter 268 Trials Can Inform or Misinform: “The Story of Vitamin A Deficiency and Childhood Mortality”
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     Chapter 270 Pragmatic Randomized Trials Using Claims or Electronic Health Record Data
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     Chapter 271 Inferential Frameworks for Clinical Trials
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     Chapter 272 Biosimilar Drug Development
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     Chapter 274 Responsibilities and Management of the Clinical Coordinating Center
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     Chapter 275 Financial Conflicts of Interest in Clinical Trials
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     Chapter 276 Adaptive Phase II Trials
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     Chapter 277 Generalized Pairwise Comparisons for Prioritized Outcomes
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     Chapter 279 Biomarker-Driven Adaptive Phase III Clinical Trials
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     Chapter 280 Sequential, Multiple Assignment, Randomized Trials (SMART)
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     Chapter 281 Diagnostic Trials
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     Chapter 282 Multicenter and Network Trials
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     Chapter 283 Qualifications of the Research Staff
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     Chapter 284 Pharmacokinetic and Pharmacodynamic Modeling
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     Chapter 286 Long-Term Management of Data and Secondary Use
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     Chapter 287 Introduction to Meta-Analysis