The Division of Pediatric and Maternal Health at the FDA in collaboration with the Division of Psychiatry is seeking a fellow who is interested in working on a regulatory science project.
Up to 42% of recently completed pediatric trials have failed to establish either safety or efficacy, with the majority failing to establish efficacy, leading to an inability to label the product for use in children. The project is a retrospective review and analysis of patient level data (adult and pediatric) from new drug applications (NDAs) to explore trial design elements or conduct that may contribute to the negative findings and provide a framework for optimizing trial design for future pediatric drug development. Under the guidance of mentors with clinical, regulatory and statistical expertise, the participant will gain knowledge in trial design considerations that can impact response in drug development. In addition, the participant will learn about methodological features of studies, data curation and database building, data analysis, dissemination of results (presentations, publications), etc. Opportunities are available for current students in a Ph.D. or other professional doctorate program and graduates with a doctoral degree in statistics, pharmacometrics, etc. Interested applicants should apply directly using the link below: https://www.zintellect.com/Opportunity/Details/FDA-CDER-2020-0575 Lily Mulugeta, PharmD [email protected]<mailto:[email protected]> Associate Director, Policy and Research Division of Pediatric and Maternal Health Office of New Drugs, CDER, FDA
