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 is 28 February 2018.
The document is also available by clicking here.
Comments should be provided using this template and sent to ich@ema.europa.eu.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please consult our brochure.
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With kind regards,
Ivan Sebest
Stakeholders and Communication Division
European Medicines Agency
30 Churchill Place
London, E14 5EU
United Kingdom
ivan.sebest@ema.europa.eu