Skip to main content

Course Schedule

Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMIntroduction to Emulated Trials & RWERationale, definition, features, when to consider an emulated trial, explanatory vs. pragmatic trials, planning a hypothetical target trial and its emulation, comparisons of baseline covariates; examplesSean Hennessy, PharmD, PhD
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMR Lab 1: Introduction to RDownloading and installing R and RStudio; working in the RStudio environment; importing data; data manipulation and visualization; descriptive statistics (mean, SD, median interquartile range, relative frequency)Peter Yang, PhD
Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMHealthcare Data for Emulated Trials and RWE; Measures of AssociationSources of healthcare data (claims, electronic health records, registries); identifying exposures, outcomes, and confounders; validation studies; measures of association (risk, risk ratio, risk difference, rate, rate ratio, rate difference); examplesSean Hennessy, PharmD, PhD
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMR Computer Lab #2Generating “Table 1” with standardized differences; tabulating a 2×2 contingency table; calculating risk, rate, risk difference, risk ratio, odds ratio, rate difference, rate ratio with 95% CIsPeter Yang, PhD
Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMBias in Emulated Trials & RWEIntroduction to directed acyclic graphs; prevalent user bias; collider stratification bias; depletion of susceptibles; immortal time bias; examplesTodd A. Miano, PharmD, PhD
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMJournal Club #1Applied Example of an Emulated TrialTodd A. Miano, PharmD, PhD
Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMConfoundingDefinition, illustration, approaches to dealing with (restriction, matching, multivariable models, weighting, negative control outcomes, instrumental variables), examplesCharles E. Leonard, PharmD, MSCE, MPH
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMJournal Club #2Applied Example of a Study Using Traditional Confounding Adjustment Charles E. Leonard, PharmD, MSCE, MPH
Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMPropensity ScoresRationale, definitions, construction, diagnostics; use (adjustment, matching, weighting); examplesTodd A. Miano, PharmD, PhD
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMR Computer Lab #3Generating, diagnosing and using propensity scoresPeter Yang, PhD
Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMWeighting by probability of treatment and censoringMotivation, definition, approach, examples of inverse probability of treatment weighting, overlap weighting, and inverse probability of censoring weighting, examplesTodd A. Miano, PharmD, PhD
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMR Computer Lab #4Implementing inverse probability of treatment weightsPeter Yang, PhD
Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMExternal Control ArmsRationale, definition, selection, challenges in eligibility matching, endpoint harmonization, follow-up alignment, analysis, examplesSean Hennessy, PharmD, PhD
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMJournal Club #3Applied Example of a Study Using an External Control ArmSean Hennessy, PharmD, PhD
Time (US Eastern Time)TitleTopicsInstructor
9:00 – 10:30 AMSequential Nested Trials and Clone-Censor-WeightingMotivation, approach, examplesEllen Caniglia, ScD
10:30 – 10:45 AM15-Minute break
10:45 – 12:15 PMJournal Club #4Applied Example of a Study Using Clone-Censor-WeightingEllen Caniglia, ScD