Clinical Research Track

CLINICAL RESEARCH FELLOW GUIDELINES

Division of Pediatric Hematology/Oncology
University of Washington/Seattle Children’s Hospital/Fred Hutchinson Cancer Research Center

Purpose of these guidelines:
(1) To answer common questions about the clinical research (CR) track
(2) To provide general information about getting started
(3) To outline expectations and opportunities for completion
Goal: The goal of the CR track is to provide early career development in clinical research. The expectation is that fellows on this track will gain critical knowledge and skills necessary to launch a successful academic career focusing on patient-oriented (AKA clinical) research.
Fellowship CR training generally consist of 2 parts:
1) Formal and broad introductory training in disciplines relevant to clinical research methods, such as:
a. clinical epidemiology
b. health services research
c. biostatistics
d. health economics research
e. qualitative methods
f. quality improvement research
g. bioinformatics
2) Provision of a focused research experience emphasizing 1 or 2 of the above method areas and successful completion of at least 1 clinical research project by the end of fellowship as evidenced by: publication of results in the peer-reviewed literature, successful competition for funding to continue research after fellowship, and/or successful completion of a master’s thesis. Additional metrics of success include presentation of results at a National Meeting.

The first item is often done largely in the School of Public Health. The second item is equally important and is done in the context of the fellow’s scholarly work project(s).
Common research activities can include one or more of the following:
1) Analysis of existing data or meta-analysis (most likely to be completed within the fellowship)
2) Integration into ongoing research projects (fellow needs to have unique piece to call her or his own)
3) Independent design and execution of a project (more challenging as often can require more than 2 years, but provides opportunity to learn all steps of clinical research – please carefully consult with your mentor and fellowship director to determine if this is appropriate)

Generally, it is a good idea to have at least 2 (but no more than 3) of the above during fellowship. Your mentors and CR team can help identify projects that are more (or less) likely to be successful during fellowship.
How is clinical research different than lab research?
1) Fellows on the CR track generally play a larger role in formulating their early research questions and research design. (In basic/lab-based science, a fellow’s first research question is usually formulated by her or his mentor.)
2) Formal training in clinical research is required, preferable completing a Master’s (MS or MPH) degree or completing a program of coursework relevant to clinical research and the chosen research topic in the School of Public Health (or other) at UW, or).

Like lab research, CR training can have many facets and nuances (no two CR tracks will look exactly alike). The consistencies in CR training are the broad approaches to formal training in combination with the fellow’s own development and analyses of his or her work.

RESEARCH PATHWAYS
There are three common pathways for clinical research training in our Division. Each pathway has some advantages and disadvantages. We will describe each one briefly below. There also may be ways to combine or create hybrids of these pathways. The goal of this document is to aid the fellow in developing an individualized scholarly training plan that will meet both the fellow’s goals and the Division criteria for completion of scholarly work.
1) Mentor is a trained clinical researcher in the Division: This pathway is in some ways the “safest” option, but requires that you find a research mentor in the division who has clinical research training and is doing clinical research in an area that interests you. The advantages are that this person may have a research question and project ready to go that you can pick up. There also may be more resources available to you (office space, computer, statistical help, databases to work on). The disadvantage is that you are limited by the finite number of CR mentors within the Division and you may not be interested in working in their specified research areas.
2) Mentor is a trained clinical researcher outside the Division: There are many epidemiologists, health services, and outcomes researchers at Seattle Children’s, the Hutch, and the University of Washington who are working in areas related to hematology or oncology (cancer epidemiology, etiology, prevention, bioinformatics, bioethics, palliative care, etc). It is possible to work with these individuals along with a Division co-mentor. Advantages include availability of resources that the Division might not have and topic areas that Division faculty may not cover. Disadvantages include the possibility of “falling between the cracks” as far as being supported within the Division.
3) Mentor in Division has clinical expertise; co-mentor has clinical research training: There are a number of clinical experts within the Division who may have expertise in and access to a specific patient population but who don’t have formal training in clinical research methodologies. Fellows interested in a particular clinical entity may be mentored by these experts and also be aided by another clinical investigator in the division. Advantages include the opportunity to do research and to develop additional clinical skills in an area of particular interest. Disadvantages include co-mentors providing less that full support and the intrusion of clinical expectations into time that should be dedicated to research.

THE RESEARCH QUESTION
The most important feature of any research project is “the research question.” The art of developing good research questions is a learned skill that requires considerable time and energy to develop. The good research question is written in such a way that it is clear how it could be answered. The best way to develop a research question is to identify a question that has come up during the clinical year or in reading about a particular field and then figure out how to answer it. A less effective way to develop an interesting research question is to identify a database and then try to figure out what questions could be asked of the database. We encourage fellows to have a “start-up” or “secondary” project based on a research question developed by a mentor that may utilize existing data. This allows the fellow to “hit the ground running” and offers the potential opportunity to submit an abstract for a national or international meeting during the fellow’s first research year. Fellows may need to consider many research questions before settling on 1 for a major project. Consider keeping a file of potential research questions that occur to you. It is also perfectly reasonable to approach a potential mentor and ask, “Do you have research questions in your area of interest that would be appropriate for fellows?”
The most important criteria of any research question are:
1) The question is interesting to the fellow (and others).
2) The question can be feasibly answered during the fellowship.
3) The question is novel.
4) The question can be restated as a testable hypothesis.
5) The question should build on the fellow’s and/or mentors experiences.

It is easy to think of interesting questions that aren’t feasible and feasible questions that aren’t interesting. The trick is to come up with a research question that fulfills both of these criteria. Of the first two criteria, the second is the most difficult.

YOUR TEAM
Many CR fellows put together teams with complimentary expertise. Your team must include at least one main mentor, and may include additional co-mentors or advisors who provide focused expertise and guidance. In addition, all CR fellows regularly interact with the division’s CR faculty and report to a separate scholarship oversight committee. Details about these terms are listed below.
Mentors: A mentor plays a central role in the fellow’s research activities and career development. Mentors and fellows meet frequently (at a minimum once a month, preferred at least every other week, plus additionally as needed). Mentors help develop research project(s), supervise their conduct, finalize scholarly work products (e.g., manuscript writing), and also provide career development advice. Fellows should take an active role in initiating meetings with their mentors and seeking additional guidance as needed.
Co-Mentors: Sometimes fellows will have an additional “co”-mentor whose expertise compliments that of the “main” mentor. Just as with the main mentor, Co-Mentors are defined by their degree of involvement in project oversight and career development. Fellows should have no more than two mentors (one “main” and one “co-“).
Advisors: Advisors (like co-mentors) provide directed content expertise and guidance, but are less involved in fellow’s regular activities. A typical advisor role is relatively passive; advisors may wait for you to make an appointment and may only provide assistance when asked. At most, you will meet with advisors once monthly. Examples of advisors can include experts in specific methodologies (i.e., statisticians) or content topics (e.g., a cardiologist for fellows studying cardiovascular outcomes). Advisors within the School of Public Health can provide guidance in course work.
FHCRC/SCH Hem/Onc CR faculty team: The Division CR faculty include Scott Baker, MD, MS (Survivorship, AYA, Outcomes, BMT); Eric Chow, MD, MPH (Survivorship, Outcomes (cardiovascular & metabolic), BMT); Abby Rosenberg, MD, MS (AYA, Psychosocial Oncology, Palliative Care, Bioethics); and Kasey Leger, MD, MS (Survivorship, Biomarkers; Cardiovascular Health, Leukemia/Lymphoma). A member of this team may double as a mentor; if not, at least one should serve as an advisor. Try to identify at least an advisor from this group early on during your first year of fellowship, so that this person can advise you on master’s applications, research mentor selection, etc.
The CR team also meets once monthly at a “Survivorship and Outcomes Meeting” to discuss ongoing research projects (including presentations of works-in-progress), as well as the relevant state of the science. CR fellows will be invited to these meetings and will be expected to participate with at least 2 works-in-progress presentations annually (plus others as directed by mentors). This participation will provide you with opportunities to learn about other applications of your training as well as outside perspective of your own work.
Scholarship Oversight Committee (SOC): All fellows (not just CR fellows) will report to an independent SOC. Please refer to the hem/onc server for details and roles of the SOC. Briefly, the SOC is designed to make sure you are on track to graduate from fellowship. (It is the job of your mentors and advisors to actually help you fulfill the fellowship requirements for CR fellows covered on page 1).
Picking your team: Picking advisors is easy. Any faculty member who provides useful advice can fill this role. Picking mentors is a bigger decision and may require the help of several advisors. Fellows should also talk to other fellows mentored by a prospective mentor, but remember that identifying the right mentor is an individual and personal decision that depends not only on the mentor’s mentoring skills, but also on matching the personalities of the mentor and fellow.
Your final team will consist of your main mentor(s) and a few key advisors. In total, there should be no more than 3-5 people. If your main mentor is NOT a member of the pediatric hem/onc division, then at least one of your advisors MUST be from the division. It is helpful for you (and for the faculty) if the team members know each other and their roles. For this reason, we recommend twice annual meetings with your full team. You should set the agenda – it can be about progress updates, career development plans, etc.

What to expect from your Clinical Research Mentor(s)
In general, fellows can expect their mentors to:
1) Help fellows determine their goals from the research fellowship and set an individualized time table for accomplishing those goals.
2) Help identify interesting and feasible research questions.
3) Meet on a regular basis (not less than 12 times a year.)
4) Supervise the design, development, data collection, data analysis, and interpretation of one or more of the fellow’s studies (mentors who meet these expectations should generally be co-authors on the abstract and paper.)
5) Help the fellow choose a mechanism for obtaining research training and help the fellow choose course work and navigate the School of Public Health (some mentors will appropriately delegate this responsibility to the Primary Advisor.)
6) Work with the fellow to find the right balance between supervising the fellow and allowing the fellow independence.
7) Foster the fellow’s productivity and provide some assistance/direction when necessary.
8) Help the fellow with choosing appropriate timing and sources for grant applications.
9) Facilitate the fellow’s career advancement and help the fellow transition their career upon completion of training.

Questions for potential mentors
A) Projects

1) What projects are you working on?
2) In what stage of completion are they?
3) What projects might be good for me to work on with the understanding that I would be first author if I complete the work involved?
4) Is there a project that I might work on and expect to be able to have an abstract ready for one of the primary hematology-oncology national meetings in my first research year?
5) Are you willing to mentor me if I work on data from one of your projects?
6) Are you willing to mentor me if I work on a project that is not one of your projects?
B) Practical Matters
1) If I work with you, where would I work? (The division will provide you with desk and computer if needed.)
2) If I work with you, do you have access to a computer for me?
3) Do you have additional resources for travel to professional meetings and additional research expenses?
C) Future Funding Questions
1) (When) should I write a grant to fund that year and what grants might I write?
2) If I don’t get a grant to fund my research after fellowship, what funding options might be available for me?

EXPECTATIONS FOR CR FELLOWS
1) Scholarly Work: complete a clinical research study within two years of research training, and write at least one manuscript to be submitted for publication in a peer-reviewed journal or a progress report submitted to the Scholarship Oversight Committee that is formatted as a manuscript and includes timeline for completion and submission of full manuscript. A thesis submitted for completion of requirements of a masters degree, or a successfully funded grant application may be submitted in lieu of a published manuscript.
2) Methodology Training: complete training in clinical research methodology either through the School of Public Health (usually culminating in a Masters degree) or through an organized plan of study to be supervised by your mentor.
3) Mentorship/Advisory Team: identify a Primary Mentor, and meet with this individual to review progress and plans at least 12 times a year. Mandatory for those fellows whose mentors are not within the Division of Pediatric Hematology Oncology and encouraged for all other fellows on the CR track: Identify a Primary Advisory Team that is composed of at least one member of the Division of Pediatric Hematology Oncology, one member who has a (similar) Masters degree in CR methods, public health, etc. (can be same person as mentor) and one member who may be outside of our Division or national advisee that has expertise in the area of research or patient cohort studies. Fellows are strongly encouraged to meet with combined advisory team twice annually.
4) Presentation of Work: present a Works-in-Progress presentation at least 3 times per year (including annual division presentation, “Survivorship and Outcomes Research Meeting,” and another research group, e.g., clinical research team, SCHRI or SPH-based research group to be identified via mentors.) In addition, fellows are expected to present their scholarly work at a national meeting (e.g., poster or oral presentation).
5) Scholarship Oversight Committee: per Division Training requirements, present research update to Scholarship Oversight Committee at least twice annually.
6) Human Subjects Training: complete the human subjects and research ethics training provided by the UW/FHCRC Biomedical Research Integrity program.
7) Career Development: actively seek the guidance of mentor(s) and advisor team when questions arise and check in with mentors regularly even when there are no questions.

The following activities are generally discouraged (although special cases exist):
1) Taking too many elective courses in the School of Public Health, especially to the point that it interferes with your research time.
2) Writing review articles, except when you are reviewing the same literature in preparation for your research.
3) Regular teaching or clinical activities (other than those required by training or coursework).
4) Auditing courses.

SCHEDULE FOR RESEARCH YEARS
(For fellows who know their plans for CR track prior to year 1 or early in year 1):
Clinical Year (fellowship year 1):
– July-August (if not prior to fellowship): Identify a CR track faculty advisor within the division
– September – November: Apply to School of Public Health (will need a personal statement explaining why the degree is important in your career plus at least 2 letters of recommendation)
– December – May: Meet with potential research mentors, Identify primary mentor and possible additional research mentor, Identify advisory team, Identify clinical area of research questions, Identify a research project (often part of an ongoing project) to be a start-up or secondary project

First Research Year (fellowship year 2):
– July: Celebrate (briefly!), Make appointments with research mentor(s), Initiate a secondary research project if part of your agreed-upon plan with mentor(s).
– August: Formulate research questions for major project. Submit faculty/staff tuition exemption request at least 2 weeks prior to first day of fall quarter.
– September-October: Initiate major fellowship research project by this time, Meet with research mentor(s) to go over study designs, Work on secondary research project, Initiate a major research project (with IRB submission if needed), start formal coursework. Schedule your first advisory team meeting. Talk to your mentor(s) about funding plans and possible future grants.
– January-June: Work on major and secondary research projects; Submit Master’s Thesis proposal (We recommend this overlaps with fellowship research projects; however, you may need to identify an additional thesis advisor within the School of Public Health. Talk to your mentors and CR advisors about this.)

Second Research Year:
– July –Dec: Work on major research project and secondary research projects; identify national meeting and submit abstract in conjunction with mentor; Perform data analysis on at least one of the projects; Write up secondary research project; Work on grant for further funding to support research following fellowship (using major or secondary research project as preliminary data)
– Jan –Mar: Analyze data from major research project (if not yet done). Submit your master’s thesis.
– April –June: Revise/Submit manuscript from major research project or prepare progress report for Scholarship Oversight Committee (due May). Submit your master’s thesis (if not yet done).

(For fellows who know their plans for CR track later during year 1 or early in year 2):
Clinical Year (fellowship year 1):
– December – May: Decide you want to be on the CR track. Meet with potential research mentors, Identify primary mentor and possible additional research mentor, Identify advisory team, Identify clinical area of research questions, Identify a research project (often part of an ongoing project) to be a start-up or secondary project. If possible, apply for “graduate non-matriculated status” at the school of public health (this allows you to begin coursework in the fall before you officially apply for the degree). This is important in order to complete any master’s degree requirement by the end of the 2nd fellowship research year.

First Research Year (fellowship year 2):
– July: Celebrate (briefly!), Make appointments with research mentors, Initiate a secondary research project if part of your agreed-upon plan with mentors
– August: Formulate research questions for major project; Write your Master’s Degree application (will need a personal statement explaining why the degree is important in your career plus at least 2 letters of recommendation). If “graduate non-matriculated status” not yet done, you will need to submit the same application twice: once for the formal Master’s degree, once for “graduate non-matriculated status” so you can begin your coursework in the fall. Submit faculty/staff tuition exemption request at least 2 weeks prior to first day of fall quarter.
– September-October: Initiate major fellowship research project by this time, Meet with a few research mentors to go over study designs, Work on secondary research project, Initiate a major research project (with IRB
submission if needed), start formal coursework. Schedule your first advisory team meeting. Talk to your mentor(s) about funding plans and possible future grants
– January-June: Work on major and secondary research projects.
Second Research Year:
– July –Dec: Work on major research project and secondary research projects; identify national meeting and submit abstract in conjunction with mentor; Perform data analysis on at least one of the projects; Write up secondary research project; Work on grant for further funding to support research following fellowship (using major or secondary research project as preliminary data), Submit Master’s Thesis proposal (We recommend this overlaps with fellowship research projects; however, you may need to identify an additional thesis advisor within the School of Public Health. Talk to your mentors and CR advisors about this.)
– Jan –Mar: Analyze data from major research project (if not yet done). Submit your master’s thesis.
– April –June: Revise/Submit manuscript from major research project. Submit your master’s thesis (if not yet done).

WRITING A GRANT DURING THE RESEARCH YEARS
Fellows are encouraged to write at least one grant during their research training years. These grants may be to support their salary after fellowship, to provide additional funding for research activities, or both. There are many different potential sources for research funding. Some of the common ones are listed below. Fellows should discuss the pros and cons of applying for a grant during the 1st or 2nd research year and the potential grant sources with their mentors.
When writing a grant, be aware that in addition to the deadline for the grant, you need to leave time for:
1) The grant to be taken through the SCH or FHCRC Offices of Sponsored Research (location depends on your mentorship team and your project – talk to your mentor and advisors about this)
2) Internal review in the following sequence:

A. Your mentor(s) – leave them AT LEAST 2-weeks to review draft 1 and 2 weeks to review final draft
B. Other faculty members in the Clinical Research Training Track – at least 2 weeks to review final drafts
C. Your Advisory Committee – at least 2 weeks to review final drafts
To complete this sequence in a reasonable timeframe, you should plan to have a first draft of your grant done 2 months prior to the deadline. Notify potential readers well in advance.
Some Grant Options for Salary Support:
Fellows interested in a career as a physician-investigator in academic medicine will often write a grant during their 2nd or 3rd research year that will bridge them into a faculty position. Often, this kind of grant is a “young investigator award” – available through many foundations. Larger “career development” grants provide more funding and are often more successful in the 1-3 years after fellowship completion. Fellows should be talking with their mentor(s) early in the 2nd research year about any grant plans.

IMPORTANT QUESTIONS ABOUT THE MASTERS DEGREE FROM SPH
1. Should I get a Masters degree?
For most clinical research fellows the answer will be yes. The main reason to get the degree is that it will be one way that potential employers and funding organizations can recognize that you have training in clinical research (although it may be less important than publications and grants.) Also, for most fellows, once you obtain the basic course work that you need anyway to be a competent clinical researcher, you will be 75% of the way toward the degree.
2. Should I get a Masters of Public Health (MPH) or a Masters of Science (MS)?
Most fellows should get the Masters of Science at UW. The MPH program at UW has a practicum requirement. For physician-fellows, this practicum may not be a good use of your time. However, if you think you might be interested in a job in public health, global health, or government, the MPH might be better for you.
3. Should I get a degree from the Department of Epidemiology or Health Services?
The choice of a department depends on your interests. While most fellows do research that fits into the category of clinical epidemiology which is the intersection of these two departments, it is important to make sure that your department will value the kind of research you want to do. If measuring the incidence of a disease in a population lights your fire, join Epidemiology. If studying the way health care is delivered is up your alley, join Health Services. If you are in the middle, talk it over with your mentor and advisor.
4. Who pays the tuition?
The Division has a set amount of money from the Training Grant to pay for tuition, and fellows are currently eligible for “tuition exemption” which pays for up to 6 credits per quarter. The exemption does not cover the quarter you work on your thesis, so plan in advance and with the program when you will write/submit your thesis. So far, the Division has been able to cover most or all tuition for fellows; however, if there are a lot of fellows wanting to get the Masters degree, the Division may not have the funds to pay the entire cost. You may be asked to apply for additional support (ITHS tuition support or other foundation funds) as another option that will pay for your tuition. Also, if individuals don’t finish the degree within two years, they will be responsible for tuition in the third year.
5. How do I map out my course calendar or order of prerequisite classes?
Each degree has a required order of classes plus electives. Especially given the limits on tuition reimbursement and “non-matriculated” courses (see websites below and the CR team), it is very important to map out your planned coursework in advance. For example, fellows should plan to take pre-requisite foundation classes during their first year of coursework and leave electives for the second year.

SOME HELPFUL UW SPH LINKS
Graduate Non-Matriculated student (if not seeking formal degree)
http://www.grad.washington.edu/admissions/application/gnmstatus.html
Tuition exemption program
http://www.washington.edu/students/reg/tuition_exempt.html
Academic calendar
http://www.washington.edu/students/reg/1011cal.html
SPH main website
http://sph.washington.edu/
SPH’s Epidemiology program website
http://depts.washington.edu/epidem/
Within Epi MS program (probably most appropriate):
Gen’l Epi
http://depts.washington.edu/epidem/word_docs/ms_checklist.doc
Clin Res Methods track (requires addt’l coursework beyond gen’l epi MS)
http://depts.washington.edu/epidem/program/cr.shtml
Genetic Epi (this is distinct from a separate MPH-sponsored “public health genetics” program)
http://depts.washington.edu/phgen/degreeprograms/MSGE_degree.shtml
SPH’s Health Services program website
http://depts.washington.edu/hserv/ms
General deadlines (Fellows are responsible for verifying all timelines themselves!)
– GNM application (due 6 wks before quarter starts for Epi dept; may be different for other programs; for 1st time applicants, need to collect old transcripts, etc., so this can take time)
– Faculty/Staff tuition exemption form (due 2 wks before quarter starts; needs division head sign-off, so plan accordingly)
– Tuition exemption registration (usually 3 days after quarter starts to allow for other grad students who have priority to register for key classes). This means you cannot register for your classes until the 3rd day of each quarter.

OTHER RESOURCES
– The ITHS clinical research seminars (https://www.iths.org). These are outstanding and include a career development series, a clinical research education series, and a “boot camp” each summer.
– The fellow’s college (http://www.seattlechildrens.org/healthcare-professionals/education/gme/fellows-college/) has additional seminars directed at peds fellows that are very helpful.
– Certificate programs through UW SPH: http://sph.washington.edu/prospective/edprograms.asp?degree=cert
– Palliative Care Center of Excellence: http://uwpalliativecarecenter.com/
– Depending on specific interests, there are also research interest groups via FHCRC (patient-reported outcomes research group, biobehavioral outcomes research group, cancer-prevention and epidemiology, global health, etc.). Likewise, there are developing groups in the SCH Research Institute, including a group focused on QI research methods, outcomes research methods.