In-Person Course: Regulatory-Grade Causal Research in Pharmacoepidemiology

Learn to Use Target Trial Emulation for Regulatory Real-World Evidence Generation

This in-person course will give you the resources to understand and implement the target trial emulation framework in regulatory studies that use real-world data (RWD). We will review tools for causal thinking, such as causal diagrams, and will provide the resources for design, analysis, and interpretation of causal regulatory studies using the target trial emulation framework.

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Learning objectives 

• Understand how causal inference is different from prediction and description, and what the identifying conditions are. 
• Design causal regulatory RWE studies using the target trial emulation framework. 
• Interpret the results of target trial emulation studies and understand limitations of this approach. 
• Review applications of target trial emulations, including regulatory applications. 

Key topics 

• Beyond controlling for confounding: design strategies to avoid selection bias and improve efficiency 
• Static and dynamic exposure strategies: implications for study design and analysis 
• Target trial emulation and external comparators 

This workshop is hosted by RTI Health Solutions, with the support of SIGMA Consortium.