Drug Evaluation Committee Causal Reasoning for Understanding ICH E9(R1)
There is a growing awareness of the importance of understanding the concept of causal inference when establishing an estimand for a clinical trial.
Moreover, discussing estimand using the framework of causal inference will deepen our understanding of ICH E9(R1) and lead to the planning and analysis of clinical trials that implement ICH E9(R1).
Therefore, we, the Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Data Science Subcommittee 2020 Continuing Task Force 1 Causal Inference Subteam, explained the basics of causal inference and each analysis method, and then described examples of the application of causal inference to clinical trial data.
The subteam also touched on the relationship between estimand and causal inference in clinical trials, including the impact of COVID-19 on estimand as a recent topic.
We hope that this document will help you to understand ICH-E9(R1) and to plan, conduct, and interpret the results of clinical trials.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
DS Subcommittee 2020 Ongoing Issues Team 1