Developing a Clinical Research Career: How to get Started

1. Developing a Clinical Research Career: How to get Started Michael G. Shlipak, MD, MPH Professor In-Residence Departments of Medicine, Epidemiology and Biostatistics University of California, San Francisco Division Chief, General Internal Medicine San Francisco VA Medical Center

2. 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 else’s clinical trial • More than just a hobby or side activity

3. You can be a clinical researcher • You don’t have to give up a normal life • You don’t have to be a workaholic • You don’t 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

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

5. Topic I: Should You do clinical research?

6. Why choose a career in clinical research? • It’s 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

7. 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

8. 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

9. Topic II: Where do good ideas come from?

10. Where do ideas come from? • Greatest mystery/scariest part of research • Clinical practice – how often is your clinical work really evidence-based rather than tradition-based? • Limitations of current research (at the end of every paper’s discussion section) • Taking a public health perspective (under-treated/over-treated, costs of therapy, potential lives saved)

11. How to generate an idea • Ask around to senior clinicians about challenges • Read guidelines – opinion vs. evidence • Read (or skim) lots of journal articles - not necessarily whole articles, but at least the abstract • Review articles • Learn what your specialty journals publish • For articles on your topic of interest – scrutinize them intensely • Journal club

12. Think Broadly about a Topic • Your first paper will probably not be a large RCT. • The perfect study may be many years away. • Take a “contrarian” view versus current dogma; demand evidence and challenge assumptions • 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)

13. 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 • Don’t clutter your schedule

14. 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 mentor • Best ideas – favorable balance of risks and rewards • Risks = time, negative results, publishability • Rewards = importance of the paper

15. 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

16. 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 and approach potential collaborators on your behalf • The fear of the “stolen idea” is probably over-blown

17. 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

18. 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 you’ll publish in.

19. Topic III: Searching for mentors http://acpers.ucsf.edu/mentoring/mentoring_program_guideli.php

20. What to look for in a potential research mentor • Must be an active researcher  must be productive in papers; ideally independently funded • 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 is really good at grant writing.

21. 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

22. Broaden your search for a mentor • Mentors do not have to be in your specialty - research methods overlap a lot across disciplines • UCSF has mentor training programs; and lists of candidate mentors in clinical research • Each department and division at UCSF has someone assigned to be a mentorship facilitator • Great mentors always put your interests above their ego • Do not stick with a bad mentor relationship: • If it’s not working- move on

23. Multiple Mentors can be Optimal • 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

24. Good mentors give bad news • Caution: don’t 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, that’s not worth the effort” (bad idea)

25. You need to manage your mentors • Be proactive and schedule several short meetings • Be respectful: • 1 week for paper/abstract • 2 weeks for letters of recommendation • 3 weeks for a long grant proposal (warn them in advance) • Be organized – have an agenda/use their time effectively • Be responsive when they need you • Be appreciative when they help you

26. Topic IV: Priorities for Fellows/Junior Faculty

27. Time Management • Top priority – must be able to write papers original research papers and get grantfunding! • Coursework is important, but. . . • Teaching is important, but. . . • Seeing patients (moonlighting) is important, but…

28. 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 don’t publish it, then it never happened • Your success as a research fellow (or early faculty member) will be judged by your productivity in papers

29. 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 2-3 months 3 1 month 1 month 6 months 1-2 years

30. Topic V: Other lessons learned

31. 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.

32. 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, don’t read it for a day or two; take out your aggression productively.

33. 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” • Focus might emerge after your first 2-3 papers • Examples • Specific disease (or complication) – “CV effects of kidney disease”; “Health consequences of PTSD” • Methodology • e.g. cost-effectiveness, survey design, genetics, clinical trials • Population • e.g. homeless, nursing home inhabitants, dialysis patients

34. 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

35. 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 – REALLY!!! • 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

36. Juggle Several Projects • Each project has its own risks/rewards • All projects have predictable delays • Never stop looking for new ideas/opportunities! • Multiple projects insures that all your research days can be productive • Another reason for collaboration – it multiplies productivity • New projects may expose you to new mentors.

37. Thank You