Standardization and Outreach Subteam
Published July 2026
The Standardization and Outreach Subteam has published a practical, cross-industry template to support the consistent and transparent use of covariate adjustment in clinical trial protocols and statistical analysis plans.
The template provides adaptable language and guidance for:
- Continuous, binary, and time-to-event endpoints
- Conditional and marginal estimands
- Primary, sensitivity, and supplementary analyses
- Covariate selection, missing baseline covariates, and variance estimation
Aim and Plan
The Standardization and Outreach Subteam advances consistent, rigorous use of covariate adjustment in clinical trials. Our work focuses on methodological guidance, harmonized terminology, practical templates, and outreach to the broader statistical and clinical research community.
[Methodological Guidance]
Collaborate with other subteams to recommend appropriate covariate-adjusted analysis approaches for a range of endpoint types, aligned with the defined estimand framework. Develop comprehensive procedures and implementation best practices.
- 1.1 Continuous endpoints
- 1.2 Binary endpoints
- 1.3 Categorical endpoints
- 1.4 Time-to-event endpoints
2. Standardization
Promote harmonized language for covariate adjustment in clinical trial documentation. Develop a standardized lexicon to support consistent terminology and definitions, along with practical templates for:
- 2.1 Protocols
- 2.2 Statistical Analysis Plans
- 2.3 Clinical Study Reports
3. Outreach and Engagement
Raise awareness of appropriate covariate adjustment in clinical trial analyses and promote the working group’s resources and outputs.
- 3.1 Digital platforms: Establish dedicated channels (e.g., LinkedIn and X) to share insights, best practices, and working-group updates.
- 3.2 Content calendar: Develop a regular schedule of posts covering key topics, recent research, and highlights from relevant industry conferences.
- 3.3 Community engagement: Engage the wider statistical and clinical community by sharing relevant work, hosting webinars, and participating in conferences and discussions.
People
Co-leaders: Yu Du (Eli Lilly) and Daniel Backenroth (Johnson & Johnson)
Members: Helena Chang, Leiya Han, Victoria Johnson, Kelly Van Lancker, Hongfei Li, Sarwar Mozumder, Satrajit Roychoudhury, Jiawei Wei, Alan Wu, Dong Xi, Yanyao Yi