Biostatistics

  1. Clinical Trial Methodology
    1. Trial Phases and Design
      1. Phase I Trials
        1. Dose-Finding Studies
          1. Safety and Toxicity Assessment
            1. Escalation Designs
            2. Phase II Trials
              1. Efficacy Screening
                1. Single-Arm vs Randomized Designs
                  1. Futility Monitoring
                  2. Phase III Trials
                    1. Confirmatory Studies
                      1. Superiority vs Non-Inferiority
                        1. Equivalence Trials
                        2. Phase IV Trials
                          1. Post-Marketing Surveillance
                            1. Long-Term Safety
                              1. Real-World Evidence
                            2. Randomization in Clinical Trials
                              1. Simple Randomization
                                1. Implementation and Properties
                                  1. Advantages and Limitations
                                  2. Restricted Randomization
                                    1. Block Randomization
                                      1. Stratified Randomization
                                        1. Minimization
                                        2. Adaptive Randomization
                                          1. Response-Adaptive Designs
                                            1. Covariate-Adaptive Designs
                                          2. Blinding and Control Strategies
                                            1. Single-Blind Design
                                              1. Implementation and Applications
                                                1. Limitations
                                                2. Double-Blind Design
                                                  1. Patient and Investigator Blinding
                                                    1. Outcome Assessor Blinding
                                                    2. Placebo Controls
                                                      1. Ethical Considerations
                                                        1. Placebo Design
                                                        2. Active Controls
                                                          1. Non-Inferiority Margins
                                                            1. Assay Sensitivity
                                                          2. Endpoints and Outcomes
                                                            1. Primary Endpoints
                                                              1. Selection Criteria
                                                                1. Clinical Relevance
                                                                  1. Regulatory Considerations
                                                                  2. Secondary Endpoints
                                                                    1. Supportive Evidence
                                                                      1. Multiple Endpoints
                                                                      2. Surrogate Endpoints
                                                                        1. Validation Requirements
                                                                          1. Regulatory Acceptance
                                                                          2. Composite Endpoints
                                                                            1. Component Selection
                                                                              1. Interpretation Challenges
                                                                              2. Time-to-Event Endpoints
                                                                                1. Event Definition
                                                                                  1. Censoring Considerations
                                                                                2. Interim Analysis and Monitoring
                                                                                  1. Data and Safety Monitoring Boards
                                                                                    1. Composition and Responsibilities
                                                                                      1. Independence Requirements
                                                                                      2. Efficacy Monitoring
                                                                                        1. Group Sequential Methods
                                                                                          1. Alpha Spending Functions
                                                                                            1. Stopping Boundaries
                                                                                            2. Futility Monitoring
                                                                                              1. Conditional Power
                                                                                                1. Predictive Probability
                                                                                                2. Safety Monitoring
                                                                                                  1. Adverse Event Reporting
                                                                                                    1. Benefit-Risk Assessment
                                                                                                  2. Analysis Principles
                                                                                                    1. Intention-to-Treat Analysis
                                                                                                      1. Definition and Rationale
                                                                                                        1. Handling Protocol Deviations
                                                                                                          1. Missing Data Considerations
                                                                                                          2. Per-Protocol Analysis
                                                                                                            1. Definition and Applications
                                                                                                              1. Sensitivity Analysis Role
                                                                                                              2. As-Treated Analysis
                                                                                                                1. Definition and Limitations
                                                                                                                  1. Bias Considerations
                                                                                                                  2. Missing Data Handling
                                                                                                                    1. Missing Data Mechanisms
                                                                                                                      1. Imputation Methods
                                                                                                                        1. Sensitivity Analysis

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                                                                                                                    18. Epidemiological Measures