In-Person Course: Regulatory-Grade Causal Inference in Health Research

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This workshop is hosted by RTI Health Solutions and CAUSALab.

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Learn to Use Target Trial Emulation for Regulatory Real-World Evidence Generation
Presented by RTI Health Solutions and CAUSALab.

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.

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. 

 

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Who Should Attend

Professionals involved in the design, analysis, and interpretation of causal regulatory studies of drugs, devices, or vaccines using real-world data that can face any of the following challenges:

  • Baseline confounding: for example, if the exposure was not randomised 
  • Time-varying confounding: for example, if the exposure is sustained in time (receiving multiple doses of a vaccine or a drug for a period of time) and if adherence is incomplete and could be affected by prior exposure 
  • Incomplete follow-up 
  • Uncertainty in the assignment of time zero: for example, if one of the exposures consists of not being treated or of not changing treatment 
  • Treatment strategy considers events that happen after the beginning of follow-up: for example, if treatment can be stopped if toxicity occurs or if the treatment should not be initiated until a future event occurs

Registration Fees

€1,000*

*plus VAT/IVA where applicable

Fees include Thursday lunch, break refreshments, and evening social. Lodging not included. A limited number of fee waivers are available for predoctoral students. Indicate your interest via the registration form.

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