FDA Fellowship in CGM-Based Metrics: Diabetes Progression & Treatment
A research opportunity is available in the Office of Translational Sciences/ Office of Biostatistics (OB),Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines.
Under the guidance of a mentor, the participant will support the development of new methodologies and programming codes to address the analytical approaches necessary for evaluating multidimensional data derived from Continuous Glucose Monitoring (CGM) devices, by identifying regulatory submissions [New Drug Applications (NDAs) and Biologics License Applications (BLAs)] with CGM data. The participant will develop guidelines on how to collect, provide, analyze, and appropriately interpret CGM data and summary measures to enable the utilization of these data for regulatory purposes.
The participant’s training will include:
- Develop a database of CGM trial data.
- Compare formats across NDAs/BLAs and consider how to harmonize for common analytics.
- Develop and validate statistical analysis methods.
- Provide description of missing data patterns.
- Conduct graphical exploration comparing CGM-derived and traditional glycemic parameters.
- Develop, standardize and validate tabular and graphical summaries of descriptive statistics of patient level epoch and summary CGM data, by study and pertinent patient subgroup (diabetes type, age, gender, BMI etc.).
- Provide examination of CGM metrics in the context of efficacy endpoints.
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 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.
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 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.