Causal Inference

Purpose

  • Apply advances in causal inference methodology to address industry applications in RCT’s, while taking into account the framework of ICH, e.g. E9(R1), as well as guidelines from health authorities; 
  • Promote a causal perspective on the data generating mechanisms in RCTs to facilitate selection of the appropriate methodology that best addresses the scientific question of interest;
  • Promote careful selection of estimators for the estimand of interest;
  • Promote the evaluation of assumptions of causal inference techniques with sensitivity analyses;
  • Foster discussion on the practical implications of non-collapsibility, accounting for baseline covariate (including marginal versus conditional estimands), selection bias, etc., on addressing the scientific question of interest

Objectives

  • Create a community of best practices for the application of causal inference thinking and application;
  • Propose invited sessions to the scientific conferences and invited seminars throughout the year;
  • Development a white paper on the implementation and application of causal inference methodology and thinking in the analysis of RCT data

Who we are

Core team: Alex Ocampo, Jesper Madsen, Tim Morris, Sanne Roels and Kelly Van Lancker.
SIG members: To be added - please see below if you would like to join us!

Interested in joining?

While imposing a limit of at most 2 people per company, the working group is open for all interested who are working in clinical trials and are willing to actively contribute to this ESIG: i.e. who are willing to contribute to prepare materials, sharing experience for exemplary use.

Applications including a brief biography and short description on motivation will be considered. Please send applications as per the 'How to apply' section below.

How to apply

If you are interested in joining the Causal Inference SIG, or alternatively you just have a general query, please reach out to Sanne Roels and Kelly Van Lancker.

Upcoming Events

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Webinar: Drug Development in Women's Health

The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.

PSI Webinar: Surrogacy

This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.

PSI Career Young Virtual Event (Q2 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations

This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.

PSI Career Young Virtual Event (Q3 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

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