FDA Real World Evidence Fellowship

A research opportunity is available with the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. 

This project with the Office of Medical Policy seeks to support the agency’s efforts to meet the mandates required by the 21st Century Cures Act and the Prescription Drug User Fee Act (PDUFA) VI Commitment Letter, by establishing a program to evaluate the potential use of real-world evidence (RWE) (1) to help support the approval of a new indication for a drug approved under section 505(c) and (2) to help to support or satisfy post approval study requirements. While the FDA has had some experience in the use of real-world data (RWD) to generate RWE, the landscape is large. As a result, stakeholders and regulatory authority are challenged to (1) understand the sources of real-world evidence, (2) identify all gaps in data collection, (3) describe standards, methods to analyze real-world evidence.

Under the guidance of a mentor, the participant will be trained to conduct relevant research, evaluations, and analyses, including but are not limited to: literature reviews of clinical studies that utilize RWD to generate RWE; collecting and analyzing data and studies relevant to understanding the potential use of RWE in regulatory decision-making; forecasting and anticipating potential policy opportunities and challenges related to RWD/RWE, and help identify potential solutions and approaches to address the challenges and to fill knowledge gaps. The learning objectives of this project include reports of reviewed clinical studies and analyzed data, presentations of findings, and concept papers to support the potential development of draft guidance documents.

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 is full-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.

The qualified candidate should have received a master's or doctoral degree in one of the relevant fields, or be currently pursuing a doctoral degree. Degree must have been received within five years of the appointment start date.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0528) in your email.