A Day in the Life of an Oncologist in Government
Excerpt from Achieving Career Success in Oncology: A Practical Guide, Chapter 2, by Jennifer J. Griggs, MD, MPH, Gregory A. Curt, MD, Kathleen A. Cooney, MD, and Douglas W. Blayney, MD
There are five distinct agencies of the U.S. government in which oncologists can pursue a career
- the NCI,
- the CDC,
- the FDA,
- the Department of Defense (DOD), and
- Veterans' Affairs (VA) Research and Development.
Each has a distinct and essential mission to progress in cancer medicine. Here we'll use the NCI and FDA as examples in exploring a day in the life of an oncologist working in government. (Information on other the programs can be accessed at their respective websites.)
The National Cancer Institute
By far the largest government investment in cancer research, at approximately $5 billion per year, is the NCI. There are many roles for oncologists within the Institute.
The career path of an intramural NCI investigator is most similar to that an academic oncologist. NCI's intramural clinical program is housed within the NIH Clinical Research Center in Bethesda, Maryland. NCI clinical research and training programs in surgical, radiation, pediatric and medical oncology are led by some of the most outstanding investigators in the field.
Several factors make the intramural program unique. One is the fact that all of the patients in the program are on protocol, so that investigators can focus more intently on their clinical research without clinical service or consultation responsibilities. In addition, NCI does not charge for care and pays for patient travel, both of which can be important to accessing specific patient populations in a timely way.
As would be expected from such a special resource, the emphasis is on translational research using functional imaging and biomarkers.
Approximately 10% of the NCI budget funds intramural research, but the balance of the budget goes to the extramural world in the form of grants, contracts, and cooperative agreements with cancer centers, hospitals, and universities around the world. Managing this portfolio often requires the special skills of the oncologist.
Another unique aspect of the NCI is that it has the drug development infrastructure of a drug company within government, with the capacity to screen, synthesize, formulate, and perform preclinical toxicology and pharmacokinetic studies, and implement phase I-III studies. The Monoclonal Antibody and Recombinant Peptide (MARP) facility in Frederick, Maryland, also has the capacity to create clinical grade biologic agents.
Functionally, the NCI phase I-II program is run by the Investigational Drug Branch. Here, medical oncologists place and oversee phase I and II clinical trials at some of the leading institutions in the United States and Canada.
Each oncologist is responsible for a given area of drug development: anti-angiogenic agents, signal transduction inhibitors, vaccines, monoclonal antibodies, etc. Agents can be derived from NCI's own research or through collaborations with biotech companies or the pharmaceutical industry under Collaborative Research and Development Agreements (CRADAs), Material CRADAs (M-CRADAs) Clinical Trial Agreements (CTAs), or Material Transfer Agreements (MTAs).
NCI's phase III program resides in the Cooperative Groups, which are organized with either a multimodality or specialty focus. These groups, which place approximately 25,000 new patients on study each year, are funded by the Clinical Investigations Branch.
Oncologists in the Clinical Investigations Branch are organized largely by disease specialty, and have the opportunity to work with some of the leading clinical investigators in the United States and abroad.
In addition, as discussed earlier, the NCI has an important clinical trials program in cancer prevention. The oversight of this portfolio of studies requires a different set of clinical skills by NCI oncologists as compared with treatment trials.
In particular, the potential toxicity of preventative therapy needs to be assessed in the context of a healthy patient population at increased risk for developing cancer. By their very nature, cancer prevention trials tend to be large and long-term investments.
However, prevention trials may be particularly important to public health. Despite this potential, prevention trials are less appealing as an investment for industry because of potential safety issues in a healthy patient population, the large patient population required, and the time such trials take when measured against existing product patent life. For all these reasons, NCI- sponsored trials in cancer prevention occupy a special niche.
It is important to note here that intramural scientists and physicians, like their colleagues elsewhere in the government, are prohibited from consulting for industry for remuneration and are restricted in their holding of stock in pharmaceutical or biotech industries. The salaries in government are also generally lower than those in the private sector.
The Food and Drug Administration
The importance of the FDA in bringing safe and effective cancer treatments to patients cannot be overstated. For this reason, it is critical that FDA be able to recruit and retain outstanding oncologists. One newer mechanism for recruitment is the NCI/FDA Research and Regulatory Review Fellowship Program, which seeks to train a cadre of scientists in research and research-related regulatory review so that they can develop skill sets that bridge the two distinct processes.
Fellows will learn to build awareness of regulatory requirements into the early stages of medical product development and will devise strategies to improve planning throughout the research and regulatory review phases. There are specialized programs for both oncology fellows and board certified oncologists, as well as a program that considers the real challenge of the development of cancer prevention interventions.
At more senior levels, FDA oncologists proactively develop guidance to inform industry on requirements for drug approval. The most recent guidance covers such important topics as regulatory requirements for effectiveness, endpoints based on tumor assessments, endpoints based on symptom assessment, and clinical trial design considerations.
This guidance sets the expectations for what is necessary for new drug approval to be used by FDA and its advisors on the Oncology Drug Advisory Committee.
Because cancer drug development is a complex and iterative process, FDA oncologists spend considerable time meeting with sponsors from industry articulating how the guidance applies to a particular development plan. As in the private sector, FDA oncologists work closely with colleagues in allied fields, particularly biostatisticians.
The relationship between the FDA and NCI is particularly robust and has been formalized in an Interagency Agreement intended to streamline cancer drug development. An NCI/FDA Interagency Oncology Task Force, which involves senior staff from both agencies, oversees the direction of the collaboration.
Among the highest priorities are developing biomarkers for drug development, establishing an integrated cancer bioinformatics infrastructure, and thinking through strategies for the successful development of cancer prevention.