1. Selecting /(searching for) a (feasible) research project and (appropriate) mentor Pathways to Careers in Clinical and Translational Research (PACCTR) Curriculum Core

2. Plan What is clinical and translational research Defining your expectations What is feasible? Where to look for mentors/projects Contacting potential mentors Is the mentor a good fit for you?

3. What is clinical research anyway? Research on a drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy (FDA definition) May also refer to research that is carried out in the clinical setting focused on patients (eg, health services research, registry studies, observational studies focused on a patient population, investigations using historic medical records…) Examples: –Randomized clinical trial of vit E or selenium vs. placebo to prevent prostate cancer –Studies on the effects of screening patterns and subsequent incidence rates of disease.

4. What is translational research? 2 general types: T1 and T2 T1=bench to bedside, laboratory to human Examples: –Novel inhibitor for cancer promoter gene X is discovered in cell or animal model and taken into patients through small pilot trials –Identify markers of disease presence (biomarkers) –Drug and device development T2: bedside to community (health services or policy research) Examples: –Identify barriers to using a new drug or practice in the community –Quality improvement programs –Evaluate the impact on population health of an intervention

5. What is Epidemiology? Studies of the distribution and determinants of disease frequency and occurrence Encompasses clinical research Observational: Cross-sectional, case-control, cohort Experimental: randomized trials

6. Summer Research Deadline SOM Dean’s Summer Research Fellowship: Early April –SOM student research site: http://www.medschool.ucsf.edu/studentresearch/ http://www.medschool.ucsf.edu/studentresearch/ PACCTR Summer Research Fellowship: April 16, 2007 (open to students from all schools) http://pacctr.ucsf.edu/PACCTR%20brochure%2007-08.pdf

8. Projects for students…Your goals drive your choices Do you want…. Clinical experience (ie direct patient contact?) A publication or simply to try out clinical research To work in a specific specialty/area To work with a specific person (regardless of the project) Financial compensation?

9. Your goals drive your choices Do you want…. To do a specific type of research: meta- analysis, policy work, case-control study To create your own project or join an existing project To work with a team vs work alone How much time do you have? Are you willing/able to extend that time?

10. What can you do in 2 months? Review article, maybe meta-analysis Secondary data analysis (analyze existing data and write paper—need data analysis experience) A case report (this is typically more appropriate for students during clinical years) Part of an ongoing project

11. What can you do in 2 months? Part of an ongoing project: –Interview or recruit subjects –collect data –create survey or data collection instrument –do literature review for a grant application –data analysis –write part of a manuscript in progress

12. What can’t you do in 2 months? A self-designed project using new data What does it take to do your “own” project? CHR approval (takes minimum 2 months) Recruitment (always takes longer than you think) Data collection and input Data analysis (good to know statistical programs or work with biostatistician and programmer) Write and submit paper or abstract/poster

13. Extending your time Most time intensive and inflexible are: recruitment and data collection Can enter and analyze data and write paper in “free” time So…. If motivated, you can continue/finish a project during regular classes as long as have a chunk of dedicated time at start (but you need to be honest with yourself and mentor about whether you want to do this!)

14. Examples of real students’ projects Collect public access data (SEER & US census) to correlate trends in disease over time –Chan JM, Jou RM, Carroll PR. The relative impact and future burden of prostate cancer in the United States. J Urol. 2004 Assist in review article –Chan JM, Feraco A, Shuman M, Hernandez-Diaz S.Hematol Oncol Clin North Am. 2006. The epidemiology of prostate cancer--with a focus on nonsteroidal anti-inflammatory drugs. Initiate small independent survey study that can be conducted in 6 months; complete write-up during clinical years or after. –PSA screening practices knowledge and beliefs in a large urban training hospital; Cooperberg et al, pending

15. Examples of real students’ projects Participate in data collection, cleaning, or analysis for ongoing study, and/or… Participate in write-up of secondary/minor hypothesis papers (while waiting for follow-up to accrue for main study questions) –Sheriff SK, Shohara RA, Dumican SB, Small EJ, Carroll PR, Chan JM. Lifestyle correlates of health perception and treatment satisfaction in a clinical cohort of men with prostate cancer. Clin Prostate Cancer. 2005

16. Examples of real students’ projects Assist in medical chart review or database completion to support larger study –Urologic Oncology Database & CaPSURE (Dept. Urology) –Comparison of recovery times among patients undergoing 2 different types of surgery –Describing the baseline features and follow-up experience of a population of men on Active Surveillance for prostate cancer –Comparing tumor focality (or other features at dx) in patients operated on by a single surgeon over two different time periods (…to examine potential effects of screening or identify other temporal trends) –Examining correlations between body size and clinical features at diagnosis and prognosis in prostate cancer registry study

17. Searching for a mentor/project The Bad news….. There is no comprehensive database of researchers at UCSF The Good news…. A comprehensive, university-wide, searchable database is planned With some leg work, you can find appropriate contacts

18. Where to look: www.USCF.edu UCSF home page search: Departmental websites: many have research tab Search for topic plus clinical research eg orthopedic clinical research Search for known researcher

19. Search UCSF: “Orthopedic Clinical Research”

20. Where to look: Pubmed Pubmed: search for topic and limit to UCSF pharmacogenomic AND "university of california" [ad] AND san francisco [ad]

21. Search Pubmed for UCSF researchers

22. Where to look Ask lecturers, small group leaders for contacts Student Research Offices at each of the Schools: Ask for list of mentors and students from last couple years Web Resources section of this module

23. Interesting websites to check UCSF CENTER ON SOCIAL DISPARITIES IN HEALTH: http://www.ucsf.edu/csdh/index.html http://www.ucsf.edu/csdh/index.html Center for health and the community http://www.chc.ucsf.eduhttp://www.chc.ucsf.edu Institute for health policy studies searchable website of projects: http://ihps.ucsf.edu/servlet/HtmlTemplateProjectSearchServlet?LinkName=projSearch http://ihps.ucsf.edu/servlet/HtmlTemplateProjectSearchServlet?LinkName=projSearch Center for AIDS prevention studies (CAPS): http://www.caps.ucsf.edu/resourcesresearchers.php http://www.caps.ucsf.edu/resourcesresearchers.php Women’s health clinical research center: http://www.whcrc.ucsf.edu/people/faculty.htmlhttp://www.whcrc.ucsf.edu/people/faculty.html The diabetes center: http://www.diabetes.ucsf.edu/EN/clinical_research/http://www.diabetes.ucsf.edu/EN/clinical_research/ Center for Obesity Assessment, Study and Treatment (COAST) http://chc.ucsf.edu/COAST/index.htm http://chc.ucsf.edu/COAST/index.htm Medical Effectiveness Research Center for Diverse Populations http://dgim.ucsf.edu/diversity/thematic.html http://dgim.ucsf.edu/diversity/thematic.html UCSF cancer center http://cancer.ucsf.edu/research/http://cancer.ucsf.edu/research/

24. Contacting potential mentors Targeted emails (no mass emails) Be persistent (ie if no answer, email again) Keep it short but concisely say what you are interested in (“summer project in xyz, I have experience in xyz” etc)) If get a “no” ask if others in department may be willing

25. Preparing to meet a mentor Professional etiquette – treat initial meetings with mentors like a job interview Mentors are interested in you but often very busy - help them think of how you can best support or fit into an existing program Faculty researchers take on students because: –They like to teach and it keeps things fresh –They may need assistance with a project but be on a budget –They may need someone with clinical training to assist in data collection/cleaning

26. Preparing to meet a mentor Do your homework: you don’t need to have a project in mind (he/she will help with that) but do a PUBMED search to find out what mentor has done Take some time for self-reflection - be objective, know your strengths and weaknesses; know what you are willing to do for a larger experience

27. Q’s to ask of mentors Will they be there during your available time? Have they hosted a student before? (get name and contact that person!) Explain your availability and goals and ask if they have project for you to work on

28. Q’s to ask of mentors If seems a good fit, ask about… your specific role whether publication, poster etc would be possible and whether you would be author ancillary benefits: can you attend conferences in the dept? learn a new software program etc Who else is on research team, meetings?

29. Final thoughts Many clinical researchers did not come to the field knowing it was what they had always wanted to do Instead, they tried it and loved it!

30. PACCTR* Curriculum Core George Sawaya MD, School of Medicine Rebecca Jackson MD, School of Medicine Susan Hyde DDS, MPH, PhD, School of Dentistry Jennifer Cocohoba PharmD, School of Pharmacy Roberta Oka RN, ANP, DNSc, School of Nursing Joel Palefsky MD School of Medicine * Pathways to Careers in Clinical and Translational Research