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ICH Consults On Harmonized Standards For Choosing Estimands In Clinical Trials

 
• By Vibha Sharma

An addendum to the International Council for Harmonisation's guideline on statistical principles for clinical trials proposes a new framework on how the concept of estimands can be used to help clearly describe the effects of a medicine.

Clinical trial
ICH Addendum Introduces Concept Of Estimands In Clinical Trials • Source: Shutterstock

The International Council for Harmonisation is seeking feedback on its proposal to introduce a new structured framework that seeks to make it possible to describe the effects of medicines undergoing clinical trials more clearly by linking the objectives of the trial to a suitable trial design and tools for estimation and hypothesis testing.

Specifically, the proposed framework introduces the concept of an estimand for translating the objective of the trial into a precise definition of the treatment effect that is to be estimated, the ICH says in a

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