Application of estimand framework in ICH E9 (R1) to vaccine trials

Area of Science:

• Vaccinology
• Clinical Trial Design
• Biostatistics

Background:

• Traditional vaccine evaluation prioritizes efficacy and immunogenicity.
• Vaccine safety is critical due to widespread use in healthy populations.
• Existing frameworks may not fully address nuanced clinical questions.

Purpose of the Study:

• To apply the International Council for Harmonisation E9 (R1) estimand framework to vaccine clinical trials.
• To clarify clinical questions related to vaccine efficacy, immunogenicity, and safety.
• To enhance risk assessment for vaccine development and deployment.

Main Methods:

• Utilized the ICH E9 (R1) estimand framework.
• Applied the framework to common clinical questions in vaccine trials.
• Focused on efficacy, immunogenicity, and safety endpoints.

Main Results:

• Demonstrated the framework's utility in defining estimands for vaccine trials.
• Provided a structured approach to address complex clinical questions.
• Facilitated clearer communication of treatment effects.

Conclusions:

• The estimand framework offers a robust approach for vaccine trial design and analysis.
• Improved clarity in defining clinical questions enhances vaccine safety and efficacy evaluation.
• This methodology supports better risk-benefit assessments for vaccines.