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Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA.

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Title: Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA.
Authors: Storm NE; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. nstorm@amgen.com.; Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California (USC), 1540 Alcazar Street, CHP 140, Los Angeles, CA, 90089-9014, USA. nstorm@amgen.com., Kubik C; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Priem G; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Kim M; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Lin TC; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Lange J; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., O'Connell C; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Glennane A; Global Development, General Medicine, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Bradbury BD; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Taisey MJ; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Source: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2026 Jun 19. Date of Electronic Publication: 2026 Jun 19.
Publication Type: Journal Article
Journal Info: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMA.
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  Data: <searchLink fieldCode="AU" term="%22Storm+NE%22">Storm NE</searchLink>; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. nstorm@amgen.com.; Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California (USC), 1540 Alcazar Street, CHP 140, Los Angeles, CA, 90089-9014, USA. nstorm@amgen.com.<br /><searchLink fieldCode="AU" term="%22Kubik+C%22">Kubik C</searchLink>; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22Priem+G%22">Priem G</searchLink>; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22Kim+M%22">Kim M</searchLink>; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22Lin+TC%22">Lin TC</searchLink>; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22Lange+J%22">Lange J</searchLink>; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22O'Connell+C%22">O'Connell C</searchLink>; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22Glennane+A%22">Glennane A</searchLink>; Global Development, General Medicine, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22Bradbury+BD%22">Bradbury BD</searchLink>; Center for Observational Research, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.<br /><searchLink fieldCode="AU" term="%22Taisey+MJ%22">Taisey MJ</searchLink>; Global Regulatory Affairs and Strategy, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
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  Data: <searchLink fieldCode="JN" term="%22101597411%22">Therapeutic innovation & regulatory science</searchLink> [Ther Innov Regul Sci] 2026 Jun 19. <i>Date of Electronic Publication: </i>2026 Jun 19.
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              Text: 2026 Jun 19
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