Career Options for Graduating Oncology Fellows at the NIH and FDA

Peter J. DeMaria, MD

The first Wednesday of December is a significant date for eager physicians seeking fellowship positions via the National Resident Matching Program. On this day in 2019, 567 successful candidates representing 75% of total applicants were selected as hematology and oncology fellows across 143 programs registered with the Accreditation Council for Graduate Medical Education.¹

Program-level data show that approximately half of new fellows will train at private hospital systems and half at government-affiliated institutions.² Most government-affiliated training programs operate in conjunction with state universities or county hospitals. Although many fellows will rotate through US Department of Veterans Affairs facilities, only 3 combined hematology and oncology programs are administered directly through the federal government: the National Institutes of Health (NIH) Clinical Center (CC), the National Capital Consortium at Walter Reed National Military Medical Center, and the San Antonio Uniformed Services Health Education Consortium. Part of the US Department of Health and Human Services, the NIH offers civilian fellowship positions; the others exclusively train commissioned military officers.

Jennifer J. Gao, MD

The NIH program is unique among fellowship programs, with roughly 1 in 3 NIH oncology fellows electing to continue federal employment beyond training. Given the limited exposure of most trainees to the significant role of the federal government in cancer research and drug development, it is important to consider how to attract talented new graduates to civilian careers in government service.

From 1950 to 1973—and corresponding to the wartime periods in Korea and Vietnam—an amendment to the Selective Service Act colloquially known as the Doctor Draft brought the best and brightest to the NIH CC to train as physician-scientists through the NIH Associate Training Program (ATP).³ The ATP produced a generation of faculty who later spread across the country as leaders in their respective fields. The majority of ATP affiliates entered academic medicine and were more likely to achieve professional success as full professor, department chair, or dean relative to their nonaffiliate peers.⁴ ATP affiliates accounted for 9 Nobel laureates and 10 recipients of the National Medal of Science between 1985 and 2007.⁵ The “Doctor Draft” was suspended in 1973, and the ATP closed in 1992 following a shift in NIH funding to a system of extramural grants.

Today, the NIH Intramural Research Program (IRP) remains fertile ground for investigators to launch a professional career. The modern IRP is a sprawling biomedical science institution and employs approximately 1200 principal investigators across the 27 institutes and centers that comprise the NIH. The National Cancer Institute (NCI) is the largest NIH member and employs approximately 79 medical oncologists.

Located within a 310-acre campus in Bethesda, Maryland, the NIH CC is the world’s largest clinical research hospital and provides care gratis to patients with cancer via research protocols funded by the NCI and National Heart, Lung, and Blood Institute. Of the more than 600 oncology-related studies that are currently active at the CC, many are first-in-human trials of investigational anticancer therapies.⁶

Housed at the CC, the NCI’s Center for Cancer Research seeks to attract ambitious junior investigators through the Physician-Scientist Early Investigator Program (formerly the Clinical Investigator Development Program) and the Lasker Clinical Research Scholars Program. The Early Investigator Program provides 3 to 5 years of funding, lab space, and mentoring to support early career independent research.⁷ Lasker scholars receive tenure-track appointments with the potential for 10 years of funding.⁸ The federal government offers generous benefits to recruit and retain talent including comprehensive health care, employermatched retirement contributions, and a defined-benefit pension program. Up to $50,000 of annual student loan debt forgiveness is available through the NIH Loan Repayment Program.⁹ The NIH also supports a work-life balance with programs promoting wellness, continuing education, and family care.¹⁰

Part of the NCI’s extramural program, the Cancer Therapy Evaluation Program (CTEP) funds and organizes an extensive network of cancer research and clinical trials to evaluate new anticancer agents.¹¹ CTEP physicians oversee both the Experimental Therapeutics Clinical Trials Network and the National Clinical Trials Network Program.^12,13 At CTEP’s Investigational Drug Branch, medical officers work as a conduit between academic investigators and pharmaceutical companies to produce clinical development plans for CTEP agents.¹⁴ Medical officers review letters of intent for proposed clinical trials, prioritize the proposals, and supervise the protocol writing process. CTEP, not the study investigator or pharmaceutical company, assumes regulatory responsibility for each trial.

Located at NCI’s Shady Grove campus in Rockville, Maryland, CTEP employs oncologists in all stages of their career. CTEP staff are afforded protected professional development time, and many participate in patient care and fellow education at the NIH CC.

Located in Silver Spring, Maryland, the FDA is the executive agency responsible for the oversight of more than 20,000 FDA-approved prescription drug products, 400 FDA-licensed biologics products, and 6500 medical device product categories.¹⁵

At the FDA’s Center for Drug Evaluation and Research (CDER), 33% of the agency’s $5.7 billion budget is dedicated to the regulation of human drugs.15 As part of CDER’s Office of New Drugs, the Office of Oncologic Diseases (OOD) oversees development, approval, and regulation of drug and biologic treatments for cancer and hematologic malignancies. OOD is currently staffed by more than 130 physicians, scientists, and regulatory project managers across 3 solid tumor divisions and 2 malignant hematology divisions.¹⁶ FDA physicians work collaboratively within disease-focused teams to review investigational new drug applications, new drug applications, and biologic licensing applications required to safely conduct clinical trials and bring new therapies to market.^17-19

FDA physicians work in a multidisciplinary setting with experts from chemistry, manufacturing, pharmacology, toxicology, statistics, labeling, safety, and many others to evaluate each new drug’s potential benefits and risks. In the postmarket setting, the FDA continues to provide ongoing safety oversight for drugs following the initial approval process.²⁰

The Oncology Center of Excellence (OCE) was authorized by the 21st Century Cures Act, signed into law on December 13, 2016.^21,22 Officially established in January 2017, the OCE leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices. The OCE works with centers and offices across the FDA to expedite the development of oncology and hematology medical products and supports an integrated approach in the clinical evaluation of new cancer therapies. With a mission to achieve patient-centered regulatory decision-making through innovation and collaboration, the OCE has launched many new initiatives, including Project Socrates, Project Facilitate, Project Community, Project Orbis, and Project Renewal.^23-27

The FDA seeks motivated graduating fellows interested in cutting-edge hematology/oncology, clinical trial design, and the regulatory science of drug development.²⁸ Richard Pazdur, MD, the director of OCE, encourages a culture of academic leadership and professional development. Physicians at the FDA publish original research and present at national conferences.²⁹ They organize workshops and symposia where thought leaders and regulators work together to engage the community and incorporate the voices of patients and physicians into trial design. Those interested in continuing clinical practice can do so as part of their professional development. The FDA also offers a strong federal benefits package for qualified candidates.³⁰

Excluding government employees, the current US hematologist/oncologist workforce is estimated at more than 12,000 physicians providing care across 2200 practices.³¹ Although the number of oncologists employed in federal agencies is small in comparison, the impact of their work is significant. Benefits like insurance, retirement, and leave are relatively standardized across these federal jobs, and compensation is variable but generally in line with academic university employment.³²

A starting position in the federal government does not mean closing the door on clinical medicine. Oncologists at the NIH and FDA continue to see patients and have successfully returned to patient care–focused roles after starting their careers in government. For those who choose to develop their career at the NCI or FDA, they will gain experience in clinical trials and drug development, which is highly desired by academic cancer centers and the pharmaceutical industry.

Graduating fellows seeking a rewarding and intellectually challenging career on the frontier of cancer drug development would be well served to consider a position of federal service at the NIH or FDA.

Conflict of Interest Disclosures:

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional Contributions:

The authors acknowledge the Intramural Research Program of the Center for Cancer Research, the National Cancer Institute, the National Institutes of Health, and the Oncology Center of Excellence at the FDA for support in the production of this article. The authors also acknowledge the editing contributions of Bonnie L. Casey.

References:

1. Results and data: specialties matching service 2019 appointment year. National Resident Matching Program; 2019. Accessed May 12, 2020. https://www.nrmp.org/fellowship-match-data/
2. Accreditation Council for Graduate Medical Education (ACGME) – Public. Accreditation Council for Graduate Medical Education. Accessed January 22, 2020. bit.ly/2A2Ardf
3. Park BS. The development of the intramural research program at the National Institutes of Health after World War II. Perspect Biol Med. 2003;46(3):383-402. doi:10.1353/pbm.2003.0042
4. Khot S, Park BS, Longstreth WT Jr. The Vietnam War and medical research: untold legacy of the U.S. Doctor Draft and the NIH “Yellow Berets.” Acad Med. 2011;86(4):502-508. doi:10.1097/ACM.0b013e31820f1ed7
5. NobelPrize.org. All Nobel Prizes in physiology or medicine. Accessed May 12, 2020. https://www.nobelprize.org/prizes/lists/all-nobel-laureates-in-physiology-or-medicine
6. Clinicaltrials.gov. Accessed May 12, 2020. https://clinicaltrials.gov/
7. Physician-scientist early investigator program at CCR. Center for Cancer Research. Accessed May 12, 2020. https://ccr.cancer.gov/careers/research_faculty/ccr_physician_scientist_early_career_program
8. Lasker clinical research scholars. National Institutes of Health. Accessed May 12, 2020. https://www.nih.gov/research-training/lasker-clinical-research-scholars
9. Supporting scientific discovery. National Institutes of Health. Accessed May 12, 2020. https://www.lrp.nih.gov/
10. Work/life balance. Center for Cancer Research. Accessed May 12, 2020. https://ccr.cancer.gov/careers/benefits/work-life
11. CTEP cancer therapy evaluation program. Accessed May 12, 2020. https://ctep.cancer.gov
12. NCI Experimental Therapeutics Clinical Trials Network (ETCTN). CTEP Cancer Therapy Evaluation Program. Accessed May 12, 2020. https://ctep.cancer.gov/initiativesPrograms/etctn.htm
13. An overview of NCI’s National Clinical Trials Network. CTEP Cancer Therapy Evaluation Program. Accessed May 12, 2020. https://ctep.cancer.gov/initiativesPrograms/nctn.htm
14. Investigational Drug Branch (IDB). CTEP Cancer Therapy Evaluation Program. Accessed May 12, 2020. https://ctep.cancer.gov/branches/idb/default.htm
15. Fact sheet: FDA at a glance. FDA. Updated October 18, 2019. Accessed May 12, 2020. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
16. Office of Oncologic Diseases (OOD). FDA. Updated November 4, 2019. Accessed May 12, 2020. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-oncologic-diseases-ood
17. Investigational new drug (IND) application. FDA. Updated May 12, 2020. Accessed May 12, 2020. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application#Introduction
18. New drug application (NDA). FDA. Updated June 10, 2019. Accessed May 12, 2020. https://www.fda.gov/drugs/types-applications/new-drug-application-nda
19. Therapeutic biologics applications (BLA). FDA. Updated February 24, 2020. Accessed May 12, 2020. https://www.fda.gov/drugs/types-applications/therapeutic-biologics-applications-bla
20. IND application reporting: safety reports. FDA. Updated October 9, 2015. Accessed May 12, 2020. https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-safety-reports
21. Oncology Center of Excellence. FDA. Updated March 23, 2020. Accessed May 12, 2020. https://www.fda.gov/about-fda/fda-organization/oncology-center-excellence
22. OCE annual report. FDA. https://www.fda.gov/about-fda/oncology-center-excellence/oce-annual-report. Updated February 4, 2020. Accessed May 12, 2020.
23. Project Socrates. FDA. Updated January 29, 2020. Accessed May 12, 2020. https://www.fda.gov/about-fda/oncology-center-excellence/project-socrates
24. Project Facilitate. FDA. Updated April 27, 2020. Accessed May 12, 2020. https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate
25. FDA’s external engagement and patient advocacy: a dialogue to better inform FDA of needs and priorities. FDA. March 15, 2019. Accessed May 12, 2020. https://www.fda.gov/media/122690/download
26. Project Orbis. FDA. Updated September 17, 2019. Accessed May 12, 2020. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
27. Project Renewal. FDA. Updated February 6, 2020. Accessed May 12, 2020. https://www.fda.gov/about-fda/oncology-center-excellence/project-renewal
28. Jobs at CDER: cutting-edge hematology/oncology opportunities. FDA. Updated November 15, 2019. Accessed May 12, 2020. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/jobs-cder-cutting-edge-hematologyoncology-opportunities
29. Gao JJ, Cheng J, Bloomquist E, et al. Benefit of CDK 4/6 inhibition in less common breast cancer subsets: a U.S. Food and Drug Administration pooled analysis. J Clin Oncol. 2018;36(suppl 15):1024-1024. doi:10.1200/jco.2018.36.15_suppl.1024
30. Jobs and training at FDA. FDA. Updated November 19, 2019. Accessed May 12, 2020. https://www.fda.gov/about-fda/jobs-and-training-fda
31. Kirkwood MK, Hanley A, Bruinooge SS, et al. The state of oncology practice in America, 2018: results of the ASCO practice census survey. J Oncol Pract. 2018;14(7):e412-e420. doi:10.1200/JOP.18.00149
32. Physician. USAJOBS. Accessed May 12, 2020. https://www.usajobs.gov/GetJob/ViewDetails/544721600