Leonor Saldanha
Leonor Saldanha MSc PhD is Regulatory Affairs Manager at the PPD™ clinical research business of Thermo Fisher Scientific, Portugal
JournalClinical trial diversity and regulatory decision-making: Implications for dosing, safety and global alignment
Through selected case studies, this article explores how evidence gaps related to sex, ethnicity and representative trial populations have shaped regulatory outcomes across different therapeutic areas and discusses strategies for more robust evidence generation.