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ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study

As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline that establishes a framework for extrapolating drug development data from adult trials to pediatric use.

Pediatric extrapolation is defined in the ICH E11(R1) guideline as “an approach to providing evidence in support of effective and safe use of drugs in the pediatric population when it can be assumed that the course of the disease and the expected response to a medicinal product would be sufficiently similar in the pediatric [target] and reference (adult or other pediatric) population".

Pediatric extrapolation can extend what is known about the reference population (e.g., efficacy, safety, and/or dosing) to the target population based on an assessment of the relevant similarities of disease and response to therapy of the two populations.

The purpose of this guideline is to provide recommendations for and promote international harmonization of pediatric extrapolation for the purpose of supporting the development and authorization of pediatric medicines.

A standardized approach to pediatric extrapolation should reduce the likelihood of significant regional differences.

The harmonization of pediatric medicines should also reduce exposure to unnecessary clinical trials for pediatric populations, allowing for more timely access to pediatric medicines worldwide.

According to ICH, the guidance will be finalized by the second quarter of 2024.

Click this LINK to know more about the draft guideline and LINK for the Presentation.

This document provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.

This E8(R1) guidance is intended to:

(1) Describe internationally accepted principles and practices in the design and conduct of clinical studies that will ensure the protection of study participants and facilitate acceptance of data and results by regulatory authorities (

2) Provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification, during study planning, of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct

(3) Provide an overview of the types of clinical studies performed during the product lifecycle, and describe study design elements that support the identification of quality factors critical to ensuring the protection of study participants, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives

(4) Provide references to the ICH efficacy documents to facilitate the user's access to them

Click this LINK to know more about the finalized guideline.


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