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

Share on: 
-

AC Hotel Victoria Suites
Carrer de Beltrán i Rózpide, 7-9, Les Corts
08034 Barcelona Barcelona
Spain

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

Registration for this event is now closed. You can use the form below to contact our team.

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. 

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 

SIGMA character on green background

 

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

 

 

Confirmed Faculty

headshot of Vaness Didelez

Vanessa Didelez

Professor of Statistics, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen

headshot of Jaume Aguado

Jaume Aguado, PhD

Director, Biostatistics

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

Commercial/Pharma: €1000*

Non-commercial/Partners: €800*

*plus VAT/IVA where applicable

Fees include Thursday lunch, break refreshments, and evening social. Lodging not included. Academics wishing to receive the non-commercial rate must register with a valid educational email. A limited number of fee waivers are available for predoctoral students. Indicate your interest via the registration form.

Course Program

Wednesday, March 6, 2024 | 3pm - 6pm

Session 1. Data Science Tasks: Description, Prediction, Causal Inference (Xabier Garcia de Albeniz, RTI-HS)

Session 2. Confounding and Selection Biases (Xabier)

Coffee break

Session 3. Target Trial Emulation Introduction (Xabier)

Thursday, March 7, 2024 | 9am - 5pm

Session 4. Target Trial Emulation: a case study (Xabier)

Session 5. Beyond Controlling for Confounding: time zero and immortal time (Xabier)

Coffee break

Session 6. How to study the duration of treatment (Jaume Aguado, RTI-HS)

Session 7. Evaluation of dynamic strategies of treatment (Xabier)

Lunch

Session 8. Target trial emulation in a regulatory study: lessons learned (Xabier)

Session 9. Target Trial Emulation and external comparators (Xabier)

Social Hour

Friday, March 8, 2024 | 9am - 1pm

Session 10. Target Trial Emulation and COVID vaccines (Xabier)

Session 11a. Mediation analysis (Vanessa Didelez, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen)

Session 11b. Checking assumptions – negative controls, etc. (Vanessa)

Coffee break

Session 12. Competing events (Vanessa)

Session 13. What can go wrong. Round discussion (all)

Contact Us

Registration for this event is now closed. You can use the form below to contact our team.

Each document must be under 2 MB.
Maximum 3 files.
2 MB limit.
Allowed types: pdf doc docx xls xlsx.

By submitting this form, you accept the RTI-HS privacy policy.

How Can We Help You?