Maertins, Katja (2025) JAS Case Studies:Weight of Evidence Approach with Different Feedback from Health Authorities. JAS Case Studies:�Weight of Evidence Approach with Different Feedback from Health Authorities.

Abstract

Case studies for ICH S11 application is presented on two compounds: Compound A, an immunomodulator, and Compound B, an anti-cancer drug. Presented for each compound are the rationales and strategies submitted to the health authorities to support the inclusion of pediatric patients in clinical trials. The strategies for both compounds were similar by using a weight of evidence approach that included preclinical safety data to support not conducting a JAS. Feedback from the health authorities differed in the need for a JAS for both compounds and lowering the age group for Compound B. Additionally, significant modifications were made to the proposed JAS protocol by the Health Authority without explanation. These case studies together highlight differences in Health Authority feedback despite using a similar weight of evidence approach to request a waiver. Finally, sponsors should be prepared to run a JAS in the case of disparate Health Authority feedback.

Item Type:	Article
Date Deposited:	20 May 2025 00:46
Last Modified:	20 May 2025 00:46
URI:	https://oak.novartis.com/id/eprint/56839