FDA Using Real-World Data to Identify Total Knee Arthroplasties (TKA) with Higher Revision Rates Fellowship

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) located in Silver Spring, Maryland.

Research Project: The FDA has authorized hundreds of knee replacement devices (TKA) available for the American doctors and patients; however, some of them have performed poorly after some years with increased risks, such as having higher than expected revision rates (RR) and especially for certain patient populations. However, it’s almost impossible to identify them based on the American Joint Replacement Registry (AJRR) due to its inherent limitations. There is a significant gap in the scientific and clinical understanding of the long-term health outcomes of all TKAs in the US market. Thereby, it increases the level of uncertainty and inability of FDA to provide timely feedback to industry, patients, and the public. 

The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) collects data from almost 100% of all total joint arthroplasty surgeries conducted in Australia, including detailed data pertaining to patients, surgical procedures, and the prothesis combinations. Given the TKAs are almost identical in design in the US and Australia, and are the mostly conducted joint procedures in the US, we plan to use long-term AOANJRR data collected from Jan 2003 up to Dec 2021 for all this study while referencing the AJRR), to identify TKAs with higher-than-expected RRs proactively.

The OHT6 has recently reviewed complex data reported in Australian and UK national joint registries and identified two TKAs that had safety signals, i.e. significantly higher than expected RRs. We were the first country to identify and communicate these safety signals with other international regulators, which both resulted in over a half million of device recalls in the US alone and subsequent recalls in multiple countries (e.g. UK, EU, Australia). We have also issued an FDA safety communication to the public, including an online searchable tool so that patients can find out if their devices are affected.

This would be FDA’s first efforts to systematically compare patients’ demographics and clinical outcomes among international joint registries. This study aligns with FDA’s mission to protect and promote the public health proactively and enhances CDRH strategic priority “Advance Health Equity” by putting patients first and ensuring the development of safe and effective technologies. Additionally, it directly supports “CDRH Strategic Priorities 2022-2025" which is to identify and act on significant safety signals related to US marketed devices first or in coordination with other regulatory agencies.

Learning Objectives: The ORISE fellow would be able to apply his/her statistical skills to solve a real-world question raised by staff at CDRH, which may have significant impact to the medical device field in the US as well as world-wide. He/she would collaborate with a group of dedicated staff in medical device field and focus on analyzing real-world data from national joint registries to identify medical devices with higher increased risks and determine if those risks are associate with certain patient populations. Once those are identified, the fellow would be able to learn how the FDA may take appropriate actions to achieve FDA’s mission of protecting and promoting public health.

Anticipated Appointment Start Date: May 5, 2024.  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 part time or full time.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields (e.g. Biostatistics or Epidemiology). Degree must have been received within the past five years.

Preferred skills:

• Strong statistical analysis skills
• Statistical analysis knowledge using R, SAS, or Python (experience with other software may be considered)
• Hands on research experience, especially with real-world data/evidence
• Good interpersonal and communication skills
• Scientific writing skills

Eligibility Requirements

• Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.