Pharma Companies Ask for More Clarity in ICH E9 Addendum

In comments to the European Medicines Agency, leading drugmakers requested more clarification, simpler language and various other revisions for the International Conference on Harmonisation’s draft addendum to its E9 guidelines.

The E9 guidelines, which provide statistical principles for clinical trials, include an ICH draft addendum on estimands — an increasingly used term in clinical trials to identify the target of a study’s estimation, including populations of interest, variables and endpoints — and sensitivity analysis in clinical trials.

Teva, who believed the addendum’s focus was on pivotal studies, suggested its intention be stated more clearly in its scope. The addendum’s expectations for other phases of trials is unclear, it stated, such as the objectives of proof-of-concept and pivotal studies.