*Applications will be reviewed on a rolling-basis.
Two research opportunities are available in the Office of New Drugs/ Office of Immunology and Inflammation (OII), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The goal of this project is to: (i) characterize in detail (~ 50 features such as type of primary endpoint, effect size, and prevalence of the disease) all original NDA/BLA approvals in non-oncological rare diseases in CDER between 2007 and 2019 that relied solely upon externally-controlled clinical trials (~ 20 applications) and (ii) identify (from a descriptive analysis of these data) common themes in a standardized fashion that justified the sole reliance on externally-controlled trials (e.g., ethical reasons, large treatment effect, etc.). A compilation and analysis of this historical information may help FDA to develop recommendations to industry regarding the appropriate use and design of external control arms.
The participant will learn regulatory, clinical trial, and drug development concepts and terminology as the participant extracts pertinent features of externally-controlled trials from review documents for non-oncological rare disease original NDA/BLA approvals; features of various rare diseases (pathophysiology, epidemiology, diagnostic methods, and current standard therapies); as well as research methods and descriptive analyses.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment can be full-time or part-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0607) in your email.