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Assessing the impact of ICH E9.

David Brown¹, Simon Day, Rob Hemmings

¹Medicines and Healthcare Products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK.

Pharmaceutical Statistics

|April 29, 2008

Summary

The International Council for Harmonisation E9 guideline (ICH E9) standardized statistical principles for clinical trials across the EU, Japan, and USA in 1998. This paper reviews its impact on trial design, conduct, and analysis in EU regulatory submissions over a decade.

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Area of Science:

Clinical Trials
Biostatistics
Regulatory Science

Background:

The International Council for Harmonisation (ICH) E9 guideline, 'Statistical Principles for Clinical Trials', was adopted in 1998.
It unified statistical guidance across the European Union, Japan, and the USA.
This provided consistent principles for clinical trial conduct and review.

Purpose of the Study:

To evaluate the influence of the ICH E9 guideline on clinical trial practices.
To assess changes in trial design, conduct, and analysis within the EU regulatory context.
To provide a perspective on the guideline's impact ten years after its adoption.

Main Methods:

Review of regulatory submissions within the European Union.
Analysis of changes in statistical approaches over a ten-year period post-ICH E9 adoption.
Perspective-based discussion on the guideline's influence.

Main Results:

ICH E9 established a unified framework for statistical methodology in clinical trials.
Significant evolution in approaches to clinical trial design, conduct, and analysis observed.
The guideline facilitated consistent statistical principles in regulatory submissions.

Conclusions:

The ICH E9 guideline has been instrumental in harmonizing statistical principles for clinical trials.
It has demonstrably influenced and improved statistical practices in regulatory submissions.
The guideline's adoption marked a significant advancement in international clinical trial standards.