Overview
*Applications will be reviewed on a rolling-basis.
This project is located in The Office of New Drugs (OND), Immediate Office (IO). This methods study aims to understand if real-world evidence (RWE) can accurately estimate long-term medication safety and effectiveness in a simulated dataset where the “true” estimates are known. Knowledge of long-term medication safety and effectiveness from randomized controlled trials (RCTs) is often limited at the time of drug approval–especially in typically underrepresented populations–but may be evaluated with postmarket real-world data (RWD) by emulating an RCT that compares treatment durations. However, confounding is still possible with RWD. We aim to understand if positive control outcomes (i.e., adverse drug reaction) and negative control outcomes (i.e., with expected null association) can identify unconfounded comparisons for valid estimation of real-world long-term medication safety and effectiveness by using plasmode simulations developed from RWD.
Under the guidance of a mentor, the participant will learn about using administrative health claims data for RWE, including how treatment duration is measured from prescription claims data. The participant will also learn how to apply plasmode simulations with RWD to estimate hypothetical “true” unconfounded treatment effects. The participant will also be trained on how to apply marginal structural models to RWD in order to emulate RCTs, as well as how positive and negative control outcomes can be used to assess assumptions of no unmeasured confounding.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
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 appointment is for 12 months. 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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA Ethics Requirements
If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
Non-employee nature of the ORISE appointment;
Prohibition on ORISE Fellows performing inherently governmental functions;
Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
The fact that research materials and laboratory notebooks are the property of the FDA;
ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications
The candidate should have received or currently be pursuing a doctoral degree (PhD or equivalent) in one of the relevant fields (epidemiology, data science, mathematics, statistics) with anticipated completion by August 31, 2024. Candidates with a clinical doctorate (e.g., PharmD, MD) and relevant experience will also be considered. Degree must have been received within five years of the appointment start date.
Preferred Skills/ Knowledge:
Proficient in programming with R or Python
Experience creating research datasets from administrative health claims data or other complex relational databases
Experience simulating research datasets
