- From www.edx.org
CERTaIN: Pragmatic Clinical Trials and Healthcare Delivery Evaluations
- Self-paced
- Free Access
- Fee-based Certificate
- 3 Sequences
- Introductive Level
Course details
Syllabus
Overview of Design Options for Pragmatic Clinical Trials
- Types of trial designs including randomized clinical trials
- Sources of errors that could lead to erroneous trial results
Outcome Measures in Clinical Trials
- Measuring health status and disease
- Characteristics of a good outcome measure
- Types of outcome measures in clinical trials
Non-inferiority Trials
- Non-inferiority trial designs and how they differ from other designs
- Interpretation and reporting of results
Basic Analytic Methods
- Matching research questions with statistical analysis methods
- Interpreting results
- Distinguishing intent to treat from per protocol analyses
- Problems with missing data
Basic Power and Sample Size Calculations
- Relevant issues to estimate sample size in clinical trials
- Interpreting study power
- Calculating sample size using online calculators
SMART: Adaptive Treatment Strategies
- Research questions which can benefit from an adaptive design
- Analytic methods for adaptive designs
- Interpreting results of adaptive designs
Introduction to Bayesian Methods
- Statistical inference
- Comparison of frequentist and Bayesian approaches and inference
Bayesian Designs
- Bayesian method and adaptive design introduction
- Adaptive randomization and predictive probability
- Bayesian design trial interpretation
- Software tools for conducting Bayesian designs
Quasi-Experiment in Health Services Research
- Need for quasi-experiments and their limitations
- Difference-in-Differences (DID) estimators and models
Adaptive Trial Design
- Limitations of randomized traditional trials
- Common adaptive approaches and their challenges
- Covariate and outcome adaptive randomization
Logistics of Clinical Trials
- Assessing impact, feasibility and funding
- Scientific review process
- Study initiation, continuing review and audits
- Working with sponsors
Prerequisite
Introduction course (CERTaIN.1x) recommended, but not required.
Instructors
Maria E. Suarez-Almazor, MD, PhD
Barnts Family Distinguished Professor
The University of Texas MD Anderson Cancer Center
Barry R. Davis, MD, PhD
Professor and Interim Chair
The University of Texas Health Science Center at Houston, School of Public Health
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