ICH adopts E11A guideline to spur pediatric drug development
The International Council for Harmonisation (ICH) on Wednesday announced that its ICH E11A guideline, which establishes a harmonized framework for extrapolating drug development data from adult trials to pediatric populations, has reached Step 4 of the ICH process and is ready for regulators to implement in their local jurisdictions.The adopted guideline does not differ significantly from the Step 2 version, rather sections were reordered to improve the document’s flow, Lynne Yao, director of FDA’s Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research (CDER), and the rapporteur for the ICH E11A guideline, told Focus.
The guideline aims to align the various terminology and approaches related to pediatric extrapolation worldwide to expedite the approval of new drugs for the pediatric population. According to the ICH E11A concept paper, there is a gap of 7-10 years between the approval of a drug for the adult population and the inclusion of pediatric information in product labeling because of these differing extrapolation principles.
ICH released the draft guidance for public consultation in April 2022. (RELATED: ICH draft guideline on pediatric extrapolation in drug development, Regulatory Focus 6 April 2022)
Yao reviewed some of the changes in the final version with Focus. She said the draft version received more than 2,000 comments from stakeholders. Some of the changes that made it to the adopted include the revision of Figure 1 to illustrate the concept that pediatric extrapolation is a continuum and not a fixed process. This figure “was changed and helped to set up what the guideline was all about.” Figure 2, which details the pediatric extrapolation framework, was also revised.
Other changes include the addition of a new section 3.6 on the integration of evidence and development of the pediatric extrapolation concept; additional details on the use of modeling approaches for extrapolation, and the incorporations of new study approaches, such as Bayesian statistical approaches, for extrapolating data.
The guideline “describes an iterative process for understanding the existing information available, the gaps in information needed to inform development, and ways to generate additional information when required and recommends approaches to assessing factors that influence the determination of similarity of disease, drug pharmacology, and response to treatment between a reference and paediatric target population,” said ICH.
The guideline covers the development of a pediatric extrapolation concept and the development of a pediatric extrapolation plan and discusses statistical and modeling methods that can be used to support a pediatric extrapolation concept and plan. Also covered are safety considerations in the pediatric extrapolation and the timing of adolescent patient enrollment in the extrapolation plan.
The E11A guidance is meant to complement the ICH E11(R1) guidance on the clinical investigation of medicinal products in the pediatric population.
ICH E11A
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