Biostatistics Calendar 2:
This Biostatistics course is scheduled to have classes every Monday through Thursday from 5:30 pm to 8:30 pm Eastern Standard Time (EST), starting on February 1 and ending on April 25.
Week 1: Tables, Listings, and Figures (TLFs)
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Overview of TLFs
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Adverse events (by System Organ Class and Preferred Term)
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Clinical laboratory tables
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Swimlane plots
Week 2: Tables, Listings, and Figures (TLFs) II
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Efficacy tables
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Waterfall plots
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Spider plots for oncology
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Disposition and demographics
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RECIST v1.1 efficacy endpoints
Week 3: Sample Size/Power calculations
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Overview of sample size and power calculations
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Continuous and count endpoints
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Binary and proportional endpoints
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Time-to-event endpoints
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Group sequential trials
Week 4: Efficacy signal detect and Bayesian Statistics
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Simon's Two Stage Designs
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Fleming's Two Stage Designs
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Introduction to Bayesian statistics
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Sample size calculation for Bayesian trials
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Bayesian futility and toxicity gating
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Bayesian hierarchical models
Week 5: Dose Escalation/Finding
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Overview of dose escalation/finding methods
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3+3 design
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BOIN
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MCP
Week 6: Statistical Analysis Plan Writing
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Overview of statistical analysis plans (SAP)
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Writing a SAP
Week 7: MMRM
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Overview of MMRM
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Common covariance structures
Week 8: Controlling FWER and FDR for multiple hypothesis testing
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Controlling FWER and FDR for multiple hypothesis testing
Week 9: Analyzing Simulated Data from Clinical Trials
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Introduction to simulated data analysis
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Analyzing simulated data from a gene therapy clinical trial
Week 10: Analyzing Simulated Data from Clinical Trials II
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Analyzing simulated data from a medical device trial
Week 11: SDTM/ADaM Data Sets and Development of a Clinical R Shiny Application
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SDTM/ADaM Data Sets
Week 12: Development of a Clinical R Shiny Application
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R Shiny Application
