Oncology
The Highest Stakes and the Greatest Rewards
No matter which area of medicine you are drawn to, there is an oncology specialty for you to consider.
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Internal Medicine, subspecialty of Medical Oncology
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Pediatrics, subspecialty of Pediatric Hematology/Oncology
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OB/GYN, subspecialty of Gynecologic Oncology
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Radiation Oncology specialty
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Surgery, specialization in Surgical Oncology
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Urology, specialization in Urologic Oncology
The areas listed above range from specialties to subspecialties to specializations that don’t include a board examination. Depending on which area you pursue, training (including residency) will range from 5-8 years.
A career in oncology provides the opportunity to be involved in relatively young but rapidly evolving specialties, which are continuing to deliver new developments for cancer patients. Oncology blends important health care advances in a setting of committed cancer nursing, psychology and modality specialists. It is the model of multidisciplinary care where the oncologist plays an increasing leadership role in managing the cancer research and care team. And as such, oncologists have the opportunity to form the most intense, personal relationships with patients of any field of medicine.
In 2007 ASCO published a report on the Oncology workforce which predicted a shortage of up to 4100 oncologists by 2020, when an aging population and increased cancer survivorship will increase the demand for oncology visits by 48%.
As a medical student considering oncology, what should you look for in a residency program?
Ideally you will find a residency that affords ample opportunity for hands on clinical training along with a supportive environment that allows and encourages continued learning and performance improvement.
Consider a program at a Cancer Center with well developed multidisciplinary programs and specialists who focus on specific diseases. If you are interested in academics, then you should find a program in which the oncologists are actively involved in clinical or translational research that you might participate in during their residency. Academically oriented students should also be encouraged to explore taking time during medical school to participate in summer research programs or even full-year research programs, such as are available at NCI.
What are some of the practice settings you can pursue?
Oncology practice can be applied in three general arenas: academic practice, community practice, or practice in industry or government.
Academic practice is a practice closely aligned with a university or medical school, whose stated goals are generally three: education, research, and patient care. Academic physicians, in their professional lives, may emphasize one of these areas over the other two, but always endeavor to carry out the tripartite academic mission.
Community practice generally refers to either “private practice” or practice within large organizations for which care of patients is the primary goal. This includes multispecialty medical groups, staff-model HMO’s, and employment by government agencies (federal, state, county, or city) in positions where day-to-day care of patients is the primary occupation.
Industry or government practice is closely tied to the overall mission of the organization. Many industrial firms view their mission as performing research to expand knowledge and create new products as much as any academic organization. However, such firms tend to be organized to develop or support a commercial product, so it’s fair to differentiate practice within their structure. Physicians who practice in government generally work to develop or support the development of public policy primarily through implementing or developing regulations, or by supporting lawmakers.
What is the American Society of Clinical Oncology (ASCO)?
More than 25,000 oncology practitioners belong to ASCO, representing all oncology disciplines (medical, radiological, and surgical oncology) and subspecialties. Members include physicians and health-care professionals participating in approved oncology training programs, oncology nurses, and other practitioners with a predominant interest in oncology.
As the world’s leading professional organization representing physicians who treat people with cancer, ASCO is committed to advancing the education of oncologists and other oncology professionals, to advocating for policies that provide access to high-quality cancer care, and to supporting the clinical trials system and the need for increased clinical and translational research.
We invite you to explore our web site as you explore a career in oncology. Please contact ASCO (training@asco.org or asco@asco.org) for information about participating in ASCO or attending ASCO meetings.
Special Opportunity for Medical Students
ASCO has partnered with the Susan G. Komen for the Cure Foundation to offer the Susan G. Komen for the Cure/ASCO Medical Student Rotation award to U.S. medical students who are from populations currently underrepresented in medicine. Students complete an 8-10 week clinical or clinical research oncology rotation and are also paired with a mentor. The award offers a $5,000 stipend and $1,500 for travel to ASCO’s Annual Meeting. An additional $2,000 will be provided to the student's mentor. Learn more.
A Day in the Life of An Academic Oncologist
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
The specific career path you choose within academia will determine how much time (if any) you will spend on any given activity. Daily activities in academic oncology are tremendously variable. Moreover, how you spend your time over your career will change as well. Many academic oncologists travel a great deal as part of their work. As you develop greater expertise, you will be invited to speak at other institutions and to serve on national committees. Let’s look at the activities an academic hematologist/oncologist might be involved in on a daily basis.
Designing research studies and interpreting results.
An academic oncologist who devotes a substantial proportion of time to research will spend much of each day designing, conducting, interpreting, presenting, and publishing research studies. A productive researcher will have a well-conceived set of research projects that are related one to another but diversified enough to allow for continuous productivity and to prevent “dead ends” in the research program. Developing relationships with other researchers will increase the breadth and depth of your research.
Conducting research requires many things: applying for grants; working in the laboratory (either your own or that of a supervising mentor or colleague); training research staff, fellows, and junior colleagues; meeting with colleagues and the research team to review results and design experiments; presenting your research findings at weekly lab meetings and in educational conferences; and publishing your findings. Preparing a grant application requires not only time for writing the scientific portions of the proposal but also time to manage administrative issues like the budget and budget justification and supporting statements from collaborators.
Clinical investigators who conduct clinical trials or do epidemiologic or health services research are said to have a “dry lab” and need to create a schedule that allows for the same sort of time commitment as those who have a “wet lab.”
You will have opportunities (and, in fact, will be expected) to present your research findings to your colleagues in forums such as grand rounds and other conferences. It is also important for you to disseminate your research findings by publishing your work. As your expertise develops, you will also be invited to speak at other universities.
As your career progresses and you add junior faculty to your research team, your day-to-day research activities will likely be replaced with supervisory activities and mentoring. Retaining methodologic expertise and familiarity with the scientific aspects of your research program will maintain the quality and integrity of your research and will likely enhance your personal satisfaction as well.
Successfully applying for and obtaining grant funding for your research and developing a strong publication record of papers in high-quality journals are both required for advancement in an academic path with a research emphasis. It is critical for your academic success that you select an area of research and a mentoring team that will help you achieve these two equally important goals.
Patient care
An academic oncologist will often have a specific area of clinical expertise, usually specific to a disease or set of diseases. Most academic divisions include physicians board certified in oncology, hematology, or both subspecialty areas. Note that an academic hematologist may specialize in nonmalignant diseases, such as disorders of the coagulation system or other benign hematologic conditions.
Patient care includes providing inpatient and outpatient consultative services, caring for inpatients, and seeing patients during and after systemic or multimodality treatment. If you are at a specialized center, you may spend a large portion of your clinical time seeing patients for a second opinion. Outpatient care is usually partitioned into half-days of clinic. Depending on your academic career path, you will generally see patients between one half-day and five half-days a week. Inpatient care is usually rotated between faculty members for blocks of time that range from a weekend to a four-week stretch. Some academic institutions employ hospitalists who specialize in the care of inpatients, but many oncologists will try to stay involved in important decision-making when their patients are hospitalized.
Teaching
Academic oncologists have opportunities to teach medical students, residents, and hematology/oncology and other fellows. Teaching occurs in a variety of settings—classroom lectures and case-based discussions, teaching at the bedside in the inpatient setting, resident conferences such as Morning Report, and teaching while seeing patients in the office. The field of oncology advances so quickly that lectures usually require substantial revisions each year.
Some faculty members choose to lead courses for medical students or electives for residents and fellows. Such courses require a tremendous time commitment but yield tremendous satisfaction. An approachable and energetic faculty member may spend a considerable amount of time mentoring medical students and residents and may write a dozen or so recommendation letters a year.
You may choose to involve students, residents, and fellows in your research projects and will thus be training, supervising, and mentoring in the research setting as well as the clinical setting.
Administrative activities
Participation in the life of the division, the department, the medical school, and the institution is a consistent responsibility of academic oncologists. Regular attendance at faculty meetings and service on committees such as the pharmacy and therapeutics committee or protocol review committees (usually for two or three years) are expected and even required for academic advancement in many institutions.
Academic service
Academic oncologists will be called on to review submitted manuscripts for journals and to serve on local, regional, and national grant review committees. You may also serve on expert panels. Although conference calls and e-mail may reduce the amount of travel required, many senior faculty members spend a great deal of time away from their university.
Community service
As a member of a university, you will have opportunities to give lectures to community groups such as support groups and church groups and to serve on the boards of health and other community organizations. This is particularly the case if you have a larger patient practice and an area of clinical expertise.
A Day in the Life of a Community Practitioner
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
Life in the office
Care of the cancer patient in the modern era occurs almost exclusively in the outpatient setting. Consequently, the outpatient setting-whether the classic physician office, the cluster of exam rooms serving a large group practice, or the hospital outpatient department-is organized to deliver customer-friendly patient care and to make the function of the most expensive member of the team-the oncologist-most efficient. The core services delivered by the oncologist are usually delivered onsite: evaluation and management services (including new-patient consultations, return patient visits, telephone calls from patients or family for questions and for symptom management) and usually chemotherapy delivery. The office can be in a professional office building adjacent to or near a hospital or in a large medical complex, but more recently medical oncologists are seeing patients in a free-standing cancer center. These individual cancer centers feature work spaces for other members of the cancer care team, including radiation oncologists, chemotherapy infusion nurses and pharmacists, and other support personnel including dietitians, social workers and data managers and clinical trial coordinators. For most community practitioners, the day is organized around the office.
Often the professional day starts with hospital rounds. There may have been a patient admitted with a complication of cancer or its therapy during the night. Usually this will be a patient known to you or to one of your colleagues, so the visit can be short. If it's a new patient to the practice, often the visit is short and introductory, and a more formal consultation can be arranged later in the day after you have reviewed the pathology material and the radiologic images. Many hospitals serve a breakfast in a private area for the medical staff. It is a good idea to make a practice of checking in for coffee for "face time"-to make contact with other members of the medical staff, to bring them up to date on mutual patients, to review medical staff activities and new treatment methods, and, especially for new physicians, to get to know other members of the medical staff who may refer patients to the practice. For hospitals still using paper records, a stop in the medical record room can be a convenience. A stop to review images and slides with the pathologist and the radiologist can often be done at this time.
Arriving on time at the office-whether it is near or far from the home or hospital-gives the oncologist time to preview patients on the schedule, instruct the staff how to work into the day the patients who called overnight with an urgent problem, and to prepare for the patient who will need extra time that day -the patient whose cancer is relapsing, who is newly diagnosed, whose family is coming from out of town, or any of the myriad other problems that will need solving. It is also time to divide up the patients with nurse practitioner or physician assistant, if you have one.
The office is usually one patient after another. It's actually enjoyable to meet new patients, to follow up on patients who are doing well, and to exercise your diagnostic and therapeutic skills on life-threatening problems and see the results unfold. One of our colleagues, who has practiced general pediatrics for thirty years, often reminds us that "behind every door there's a story." The stories are not only about illness and cancer, but also about our patient's lives. Most people have interesting stories to share, and hearing them is one of the daily satisfiers of practice.
Some oncologists reserve time to see new patients either early or late in the office session. Most see twelve to sixteen return visits each half-day and allocate 30-60 minutes for each new patient. Although this sounds like a short time, there is always pre-appointment and post-visit work to be done when the office is not in session-reviewing reports and images, documenting the interaction, and discussing with colleagues. Much of the time patients are in the office they are interacting with other members of the staff, learning about side effects of treatment or discussing financial, social, or psychosocial issues. Well-run offices are organized to assure that the oncologist delivers maximum value to the patient during the face-to-face interaction; other tasks should be delegated to easily available specialists in their areas of expertise.
Lunchtime can be used to answer telephone calls from the morning session, to eat lunch with professional colleagues (more "face time"), to catch up on documentation tasks from the morning clinic session, or to make hospital rounds. The rhythm of the day, for a specialist, is that new inpatient consultations often come in in the afternoon hours, after the pathology reports have been posted and the surgeons, internists, family practitioners, hospitalists, and pulmonologists have made their morning rounds and decided that an oncology consultation will be helpful.
Midday is also a popular time for hospital medical staff committee meetings. Medical staff have governance structures composed of physicians whose staff work (notification of meeting time and place, publishing the agenda and minutes, and arranging for attendance) is usually accomplished by hospital employees. Physician participation and oversight is necessary for credentialing new members of the medical staff, for establishing and reviewing quality of care indicators, for advising the hospital's lay governing bodies (the board of directors), and for discipline and other sanctions of members. Service on hospital committees is a duty of self-governance, can be rewarding in and of itself, and is also a way to meet new physicians who might be referral sources. If one practices in a satellite office, or one has several offices or hospitals, midday can also be travel time. The afternoon can be a repeat of the morning, seeing office patients, or can be set aside for hospital rounds and consultation.
Most oncologists develop some open time, down time, or "office time" in their day and in their week. Early in the career, the open time can be for business development: meeting new physicians, reviewing operations, or reading about challenging cases. Mid-career practitioners use this time for honing office operations, for interviewing new personnel, or for developing new skills or hobbies. Unscheduled or office time is also used for catching up on professional obligations: charting, reading medical journals, or writing. Family and personal time should also be built into the day. Some practitioners use lunchtime as a personal time, exercise time, or nap time. Afternoons are often the time for children's sports or other activities, or for being home with children after school. Meetings to begin new projects, to work on performance improvement, investment or other projects can be planned during nonscheduled afternoons. Evenings can either be family time, or a time for meetings, or a combination of both.
Night call, often one of the loathsome parts of medical training, remains a necessary component of community practice. Call is usually taken in some sort of rotation. Calls come from patients, from hospitals, and from hospital emergency rooms. Some practices will have a triage system, with nurses as the first point of contact. Others will use the physician members in rotation. Patients are usually reluctant to disturb physicians at home at night. Hospitals usually have some form of triage as well, so repeated calls about the same patient are rare. Calls from hospital emergency rooms still occur, and may necessitate a trip to the hospital.
Community Service
At some point, you should plan on being a prominent member of some aspect of the community in which you live or practice. Community service is a very satisfying part of community practice. It's a good way to meet other members of the town where you practice, of keeping in contact with business, social and political developments outside of the practice or medical community, and as a break from the sometimes difficult aspects of oncology practice. Community service can draw on your medical training (e.g., volunteering for athletic physical examinations, at a "free clinic," or on a foreign mission) or it can be completely unrelated (e.g., roles in your religious institution, your child's school or sports team, local civic organizations or government). Some oncologists find great satisfaction in organizations devoted to their hobbies. Community involvement of this type may help your practice grow. But keep in mind that, in contrast to primary care specialties, most oncology specialists find their practices growing through professional referrals, not through community or family contacts.
Recognize that this involvement may come in stages and in varying intensity as the demands of practice and family life change. By virtue of your education and experience, and the people's lives you touch daily, you will be viewed as a potential leader; often a philanthropic leadership as well as a personal leadership role will be expected. Volunteer involvement and leadership is a great way to evaluate whether a philanthropic role is likely to be valuable. You'll have an opportunity to asses the soundness and effectiveness of an organization before committing funds to it.
Service to the medical community
One way to partially fulfill your mission to become a local or regional expert is to serve your local or regional medical community. Hospital medical staff membership, leadership of hospital committees, and membership and leadership of local, regional, or national professional organizations are all available and can be a source of personal and professional satisfaction. In contrast to community activities, local hospital medical staff committees and leadership are good ways to cultivate referral of patients and to get to know the specialists to whom you may refer patients for assistance in management. Involvement in local, regional, or national oncology or medical organizations is a great way to potentially influence policy and practice, and to continually reassess your own skills and knowledge.
Teaching physician, mid-level provider, and paramedical trainees
Teaching physician, mid-level provider, and paramedical trainees is possible in a community practice. Trainees may be taught in your own office (particularly mid-level and paramedical trainees) and often with minimal involvement from the physician. (The fully trained members of those professions can often provide the minute-by-minute training and supervision required.) Not only can this be satisfying, but a training program is a useful way to spot emerging talent and can be a source of new hires who are already familiar with the practice and the work environment. Teaching physician trainees can also be done in the outpatient practice setting, in your own hospital (if it has a training program), and as a visiting or voluntary faculty member of a local training program. Satisfaction comes from dealing with new people with fresh ideas (particularly the trainees, but also faculty members of the program) and from an opportunity to assess and recruit new physicians for the practice.
A Day in the Life of an Industry Oncologist
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 really two industry universes one can consider: large pharmaceutical companies or small biotech firms. The worlds are quite different and there is actually considerable intra-company variation within each sector.
Recently, The Scientist reviewed what they considered the top 30 pharmaceutical and biotech companies.¹ The total number of employees varied from fewer than 100 to more than 20,000. There is considerable variability between companies regarding factors such as management, the research environment, remuneration and benefits, policies and practices, communication, job satisfaction, and integrity. Each company's "culture" will shape the environment in which you will work.
The size of the company will also dictate the role of the oncologist on the team. In smaller companies, the oncologist may have additional responsibilities in study conduct, regulatory, commercial or other areas of decision-making. While this may allow the chance to assume more of a managerial role than in a large pharmaceutical company, one needs to counterbalance this with the fact that, by and large, a small company with one or two products in development faces more uncertainties and restrictions in research budget than a large company.
A large company with several cancer agents at different stages in development may offer an opportunity to learn about different agents at different stages of their life cycle. Also, in a large company, your focus may change quickly depending on business needs. In a small company, your experience will depend on where a smaller number of agents stand in development. Individual entrepreneurism and risk tolerance are especially valued in these smaller companies. It is also obvious that the medical skill set, clinical trial design and study endpoints, and development strategies are quite different for targeted therapy using small compounds versus biological agents or tumor vaccines.
Collaboration with government and other agencies
Industry oncologists commonly deal with regulatory colleagues in the United States (the FDA), the European Union (the European Medicines Agency), and in countries around the world, to discuss new drug approval strategies and new indications for approved drugs. Equally important, in the future, industry oncologists will likely work increasingly closely with their counterparts in both the government (e.g., the NCI) and academic sectors. The underlying dynamics predict such collaboration. Industry will likely discover interesting new agents for patients with cancer than it has independent resources for optimal development. The NCI and academic centers have impressive platforms for phase I-II drug development (the NCI Investigational Drug Branch), translational research (the NCI SPORE Program), and phase III trials (the Cooperative Groups). It is fair to say that many of the interesting novel agents will come from the private sector for the simple reason that academic tenure does not accrue from lead optimization and formulation chemistry-the "heavy lifting" of drug development. The logical conclusion is that the public, private, and academic sectors can do more working together than they could ever accomplish in isolation.
Interdepartmental collaboration
A fundamentally broad fact of life for an oncologist in industry is the ability to meet the business needs of the company, and a fundamental skill in executing this is adaptability. If your interest is cancer drug development it will be important to learn how the process is handled within the company. Does the same team oversee an agent as it goes from phase I to development for launch (more likely in a small biotech company) or do teams transition at key milestones in development (more likely in a large global company)? If teams transition, is it possible for an individual to transition with an agent for continuity and personal training and development?
All of this requires working in a team with a wide variety of staff, including translational scientists, chemists, statisticians, regulatory experts, and marketing experts. The opinion of the oncologist on the team is obviously important, but the development plan will be influenced as well by commercial priorities and the competitive environment.
As a member of the team, your role is to make sure the team gets the medical and scientific aspects of development right, within the context of the commercial and clinical priorities. For this reason, it is also important to learn how key decisions within the company are actually made. How much autonomy do teams have? How is central oversight exercised? Is the oversight light, or heavy-handed? The location of decision makers can have a significant impact on your life in terms of the need for domestic or international travel.
1. Zielinska, E: Best Places to Work: 2007 Industry. The Scientist, May:57-63, 2007.
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 web sites.)
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, issued in May 2007, 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.
