Developing a Clinical Research Career: How to get Started

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Developing a Clinical Research Career How to
get Started

• Michael G. Shlipak, MD, MPH
• Associate Professor In-Residence
• Departments of Medicine, Epidemiology and
  Biostatistics
• University of California, San Francisco
• Division Chief, General Internal Medicine
• San Francisco VA Medical Center

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What is a Clinical Researcher?

• Chooses the topics for his/her patient-oriented
  research
• Develops original research ideas and answers them
• Financially supports the time they and staff
  spend on research (grants usually)
• A bit more than just enrolling patients into
  someone elses clinical trial
• More than just a hobby or side activity

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You can be a clinical researcher

• You dont have to give up a normal life

• You dont have to be a workaholic

• You dont have to be brilliant/a genius/manic

• You have to enjoy doing research

• To succeed it has to be the main focus of your
  career

• Fellowship is probably the best time to decide if
  research is the right career for you

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Topic Outline

• Should you do clinical research?
• Where do good ideas come from?
• Searching for mentors
• Priorities for fellows/junior faculty
• Other lessons learned

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Topic I Should You do clinical research?
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Why choose a career in clinical research?

• Its a great job if
• It fits into your skills
• Its how you want to spend your time
• Flexible lifestyle
• Opportunity to contribute to the way medicine is
  practiced
• Constantly challenging
• Variety in day to day activities

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How do you know if research is right for you?

• Is research your favorite work activity?

• Do you have skills that apply to clinical
  research?
• Curiosity/Creative ideas
• Analytic skills/Writing skills/Diligence
• Communication skills/Clarity of thought

• Is the process of discovery exciting to you?

• Decide what activity will inspire you the most
  long-term patient care, teaching, research or
  administration
• ? Are all parts of academic medicine

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What is the downside of clinical research?

• Research is a highly competitive field lots of
  faculty members want to be researchers
• Researchers tend to be judged on productivity
• Grants
• Publications
• Researchers have to be thick-skinned
• Less job security
• There are other jobs in academic medicine so
  being academic is not enough reason to be a
  researcher

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Topic II Where do good ideas come from?
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Where do ideas come from?

• Greatest mystery/scariest part of research
• Clinical practice how often in your clinical
  work do you make decisions based on conclusive
  evidence vs. dogma?
• Limitations of current research (at the end of
  every papers discussion section)
• Taking a public health perspective
  (under-treated/over-treated, costs of therapy,
  potential lives saved)

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How to generate an idea

• Ask around to senior clinicians about their
  conundrums
• Read guidelines opinion vs. evidence
• Read lots of journal articles - not necessarily
  whole articles, but at least the abstract
• Review articles
• For articles on your topic of interest
  scrutinize them intensely
• Journal club

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Think Broadly about a Topic

• Your first paper will probably not be a large
  RCT.
• The perfect study may be many years away.
• Building a research program is a series of small
  steps.
• Define the importance of the topic
• Describe limitations of current therapies
• Start with observational studies (e.g. examining
  hospital records)

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Creativity

• Requires an empty, alert brain
• Ideas not limited to 40 hour work week
• Brainstorm outside of the office
• You need to be bored sometimes
• Dont clutter your schedule

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What do you do when you get an idea?

• Do brief literature searches to see what has been
  done and take a few notes
• Make a list of research ideas to review with your
  mentor
• Best ideas favorable balance of risks and
  rewards

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Primary vs. Secondary Data

• Primary data you collect it yourself (direct
  patient contact, phone interviews, chart review,
  e.g.)
• Secondary data someone else collected it
  (existing research studies, local hospital data,
  national administrative records)
• Early career I strongly advise the use of
  secondary data
• Primary data collection is too time consuming
  wait until your career is on solid ground

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Find data appropriate for your research question

• Identify a data source in the literature, local
  or distant
• Any study you read about can be within reach
• Before contacting the PI of a distant study get
  help communication style is critical
• Use a local mentor to facilitate
• The fear of the stolen idea is probably
  over-blown

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Data driven hypotheses

• An alternative strategy
• Find out what data are available to you locally
  or through public access
• Derive a research question that can be addressed
  with available variables
• Data from many NIH studies (Framingham, e.g.) or
  from NHANES can be obtained for free

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Good or Bad Idea? Project Litmus TestCan you
envision your project as a story?

• Where does it fit in the saga of the literature?
• Evaluate risk vs. reward how exciting will the
  paper be if hypothesis is a positive result? Is a
  null result publishable?
• How broad of an audience will care about your
  project? (General public? All physicians? Your
  specialty only? Small group of researchers?)
• The broader the audience and the more
  newsworthy the better the potential journal
  youll publish in.

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Topic III Searching for mentors

• http//acpers.ucsf.edu/mentoring/mentoring_program
  _guideli.php

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What to look for in a potential research mentor

• Must be an active researcher ?productive in
  papers
• Track record of successful mentees getting jobs
  in clinical research
• Interested in your career development
• Helps if they are somewhat interested in your
  topic
• Eventually, you need a mentor who understands
  grant writing.

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Roles Of The Mentor

• Many potential roles
• Project specific - methodology, editing, research
  questions
• Career counseling grants, job advice
• Advocate promotion support, opportunities
• Often is too much to ask from one individual
• Personal qualities more important than fame and
  stature
• May not be ideal to have your supervisor as
  mentor

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Broaden your search for a mentor

• Mentors do not have to be in your specialty -
  research methods overlap a lot across disciplines
• Currently, UCSF is training faculty to be better
  mentors
• Each department and division at UCSF has someone
  assigned to be a mentorship facilitator
• Do not stick with a bad mentor relationship
• If its not working- move on

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Multiple Mentors

• Allows you to draw from unique qualities of
  several faculty
• Example career guidance and project guidance can
  come from two different people
• Example Separate content expertise from
  methodology
• Several persons to write letters, expand your
  opportunities
• Having multiple mentors protects your from the
  unexpected
• Sabbatical at inopportune times
• Academic mobility

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Good mentors give bad news

• Caution dont pick a mentor just because they
  seem really nice
• We all like people to tell us that our ideas are
  excellent/brilliant/creative/feasible
• As a mentor for residents/fellows, the best
  advice I ever give is that a particular project
  is a waste of time
• You need a mentor who can tell you, No, thats
  not worth the effort (bad idea)

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You need to manage your mentors

• Be proactive and schedule several short meetings
• Be respectful
• 1 week for paper/abstract
• 3 weeks for letters of recommendation
• 1 month for grant proposal
• Be organized have an agenda/use their time
  effectively
• Be responsive when they need you
• Be appreciative when they help you

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Topic IV Priorities for Fellows/Junior Faculty
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Time Management

• Top priority must be able to write papers
  original research papers and get grant funding!
• Coursework is important, but. . .
• Teaching is important, but. . .
• Seeing patients (moonlighting) is important, but

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Why its important to publish as a fellow

• Primary goal of research fellowship is ORIGINAL
  RESEARCH
• If you can publish original research papers, then
  future employers will think you have a promising
  future
• No matter how great your research is, if you
  dont publish it, then it never happened
• Your success as a research fellow (or early
  faculty member) will be judged by your
  productivity in papers

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Writing Papers

• You should feel a sense of urgency
• Partly for the excitement of publishing
• Partly because it takes a long time
• Average length of time. . .
• Preliminary decision
• Average rejections/paper
• For revision
• Until decision
• From acceptance until publication
• Submission to print

3 months
3
1 month
1 month
6 months
1-2 years
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Topic V Other lessons learned
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Rejection

• This is the worst part of research.
• Often our papers/grants/job applications are not
  accepted.
• For grants in particular, rejection is very
  painful, and drives many people out of research.
• Recently, the threat of potential rejection has
  caused several productive UCSF investigators to
  abandon research.

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How do researchers deal with rejection?

• Send the same grant concept to several potential
  funders
• Expect to revise/resubmit.
• Always be ready for a new funding opportunity-
  NIH, other government sources, foundations,
  industry
• When you get a rejection letter, dont read it
  for a day or two and take out your aggression
  productively.

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The importance of being focused

• Focus refers to having a specific research area,
  meaning that
• All (or most) of your projects have a common
  theme
• As this theme develops it becomes a body of
  work
• Examples
• Specific disease (or complication) CV effects
  of kidney disease
• Methodology
• e.g. cost-effectiveness, survey design, genetics,
  clinical trials
• Population
• e.g. homeless, nursing home inhabitants

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Benefits to being focused

• Simplified literature review for each paper
• Understand all the gaps in the literature
• Recognition as an expert, first locally then
  nationally.
• Experts get grant funding invitations to lecture
  all over the world, write guidelines, etc
• National recognition is essential for promotion

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Learn how to say yes and no

• Say No Anything that does not lead to
  original research papers or research funding
• Extra clinical work/teaching
• Review articles
• Book chapters
• Say Yes
• Several projects (up to 5)
• Collaborate with colleagues leads to great
  opportunities and is a fun part of research
• Peer-review submitted manuscripts with a mentor
• Attend journal clubs

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Juggle Several Projects

• Each project has its own risks/rewards
• All projects have predictable delays
• Keep looking for new ideas/opportunities
• Multiple projects insures that all your research
  days can be productive
• Another reason for collaboration it multiplies
  productivity

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Thank You