The European Medicines Agency has released for public consultation following guidance document:
The E9(R1) addendum aims to clarify and extend ICH E9 by elaborating on the choice of estimand and sensitivity analysis in clinical trials, providing a framework to align its planning, design, conduct, analysis and interpretation. Having clarity in the trial objectives and accounting explicitly for intercurrent events when describing the treatment effect of interest at the planning stage of a clinical trial are crucial for a clear description of the effects of a medicine.
The proposed framework aims to facilitate dialogue for the disciplines involved at the planning level of the trial and also between sponsors and regulators regarding the treatment effects of interest that a clinical trial should address. The statistical analysis, aligned to the estimand, will be associated with assumptions and data limitations, the impact of which can be investigated through sensitivity analysis, whose definition and role are clarified in this addendum.
Deadline for comments will be 28 February 2018.
Please for more information please click on the link below:
European regulatory system for medicinesr brochure
