This chapter focuses on the impact of the ICH E9(R1) guideline on the documentation of estimands in clinical trial documents and on the planning and reporting of clinical trial results. Throughout the chapter, these aspects are illustrated through a generic example. Points to consider regarding the documentation of the estimand and analysis methods in the trial protocol are described. The impact of the estimand on the statistical analysis plan is also discussed, and considerations are described that will facilitate clinical study report writing. Recommendations are given for reporting the frequency of intercurrent events and the way to a clear presentation of the link between the estimands, the analysis sets, and the statistical analysis methods, and key assumptions underpinning the methods in the clinical study report are discussed. Emerging practices regarding the description of results in the prescribing information and publications are also mentioned.

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Documentation of Estimands and Reporting of Results

  • Hongying Li,
  • Melanie Wright,
  • Christine Fletcher

摘要

This chapter focuses on the impact of the ICH E9(R1) guideline on the documentation of estimands in clinical trial documents and on the planning and reporting of clinical trial results. Throughout the chapter, these aspects are illustrated through a generic example. Points to consider regarding the documentation of the estimand and analysis methods in the trial protocol are described. The impact of the estimand on the statistical analysis plan is also discussed, and considerations are described that will facilitate clinical study report writing. Recommendations are given for reporting the frequency of intercurrent events and the way to a clear presentation of the link between the estimands, the analysis sets, and the statistical analysis methods, and key assumptions underpinning the methods in the clinical study report are discussed. Emerging practices regarding the description of results in the prescribing information and publications are also mentioned.