Module232025

12/05/2025

Sponsor’s Common Concerns about Risks when Including Adolescents in Adult Clinical Trials

Reasons for the Concern

Reasons for Considering

− Regulatory Risk − Scientific Complexity − Delay in Completion Adult Trial − Investor Perception

− Regulatory Mandates (PIPs, PSPs, etc.) − Scientific Rational (MoA) − Early Alignment with regulatory expectations − Commercial Advantage

The Organisation for Professionals in Regulatory Affairs

45

M Dehlinger-Kremer, 14 May 2025

45

Insights and Outcomes from Combined Adolescent-Adult Clinical Trials

The Organisation for Professionals in Regulatory Affairs

46

M Dehlinger-Kremer, 14 May 2025

46