FDA Fellowship - Evaluating Approaches for Synthetic Data Generation and Evaluation in Regulatory Submissions

Research Project

The primary goals of this research fellowship project include:

• Carry out a systematic literature and tools review on synthetic data generation models and their published applications in clinical research, including their context of use.
• Identify, operationalize, and empirically apply quantitative metrics for evaluating synthetic data quality across three dimensions: fidelity, utility, and privacy preservation.
• Synthesize and communicate research findings through internal technical reports, including technical memos, annotated bibliographies, and presentations for FDA staff.

Learning Objectives

Under the guidance of a mentor, you will:

• Acquire foundational knowledge of the regulatory scientific landscape surrounding synthetic data by exploring emerging computational challenges and methodological gaps relevant to the development of FDA-regulated products.
• Develop proficiency in systematically reviewing and comparing state-of-the-art synthetic clinical data generation approaches across fidelity, utility, and privacy dimensions, with a focus on their published applications in clinical research contexts.
• Gain hands-on experience designing and applying a reproducible evaluation framework using quantitative metrics — such as Jensen-Shannon divergence, Wasserstein distance — to assess synthetic clinical data quality using publicly available datasets.
• Build scientific communication and knowledge translation skills through translating complex computational and methodological findings into accessible findings — including technical memos, annotated bibliographies, and staff presentations — to support awareness and readiness around synthetic data evaluation in regulatory contexts.

Mentor

The mentor for this opportunity is Hussein Ezzeldin (hussein.ezzeldin@fda.hhs.gov).

Anticipated Appointment Start Date

October 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation

The appointment is full-time.

Participant Stipend

The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements

This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

Qualification Requirements

• The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the relevant fields.
• I am a U.S. Citizen; or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
• I have read the FDA Ethics Requirements.