1. Clinical Trials: How do I get started? OSP Brown Bag Session March 16, 2012 Ann J. Melvin MD, MPH Co-Director ITHS Regulatory Support and Bioethics Core

2. Objectives  Provide an overview of: How to assess study feasibility Clinical research approval process- UW Where you can go for help 2

3. 3 Study feasibility  Population  Procedures  Collaborations  Staff  Budget  Space  etc.

4. Population  Do you have access to the right patient population?  Are the enrollment goals realistic?  Will you need to recruit outside of your system?  Will enrollment compete with other studies?  Are there special consent issues?  Have you reviewed the inclusion/exclusion criteria and are they too restrictive? 4

5. Procedures  Are procedures approvable?  Are procedures frequent/painful/inconvenient?  Do procedures require special equipment/expertise? 5

6. Collaborations  Do you need additional specialists?  Do you need access to outside clinics/schools/etc? 6

7. Personnel  Do you have qualified staff?  Any special training required?  Do you need an RN?  Do you have time to devote to the protocol?  Does your staff have time to devote to the protocol? 7

8. Budget considerations  Your time  Staff time  Sub-investigator time  Consultant time  Cost of procedures  Cost of labs  Cost of space (CRC)  Cost of shipping  Records Storage  Cost of storing specimens  Pharmacy costs  Cost of data collection system  Cost of monitoring (study and site)  Cost of statistician  Manuscript preparation and presentation 8

9. Budgets  If budget is determined by sponsor do they allow time for Study start-up activities (non-refundable) Training Unanticipated activities – protocol amendments, unanticipated monitoring visits, audits, etc Keep in mind industry budgets are negotiable  If you are writing the budget, is the RFA amount sufficient for all the study activities? If not – what will need to be cut from the protocol. 9

10. Space  Do you have room for: Research personnel Study binders Any equipment needed Lab supplies OR  Will you have to look for more space? 10

11. Start up activities - contracts  Read the protocol Make sure everyone on the research team reads the protocol  Decide if the study is feasible Will study change clinical practice?  Let your Division/Departmental administrator know you are thinking of pursuing/accepting the contract 11

12. Considerations if you didn’t write the protocol  Is it well designed?  Any ethical issues?  Is there potential benefit to participants?  Will the sponsor allow modifications if you don’t think it is feasible as written?  Are the visits/procedures onerous for participants?  Drug available at the end of the study? 12

13. 13 Study start-up activities - Develop all study materials  Regulatory Binder  Study visit records  Case report forms  Eligibility checklist  Adverse event report forms  Protocol deviation report forms  Screening logs  Training logs  PI Delegation log ITHS forms - www.iths.org/forms www.iths.org/forms https://www.washington.edu/research/clinical-research-handbook//

14. Study start up activities – training  Investigator training  Staff training 14

15. 15 Training requirements  Human Subjects Protection Training Required by all IRBs Provided periodically by SCH IRB and FHCRC IRB Or on-line at CITI – Collaborative Institutional Training Initiative  http://www.citiprogram.org/ http://www.citiprogram.org/  CRBB: UW Medicine Clinical Trial Policy Clinical Research Staff

16. 16 Training requirements  Good Clinical Practice Required by some NIH consortia Required by FHCRC On-line at CITI  http://www.citiprogram.org/ http://www.citiprogram.org/  HIPAA http://www.washington.edu/research/hsd/faq_h ipaa.html http://www.washington.edu/research/hsd/faq_h ipaa.html

17. Additional educational options  ITHS CRES – Clinical Research Education Series – monthly seminars on topics relevant to clinical and translational research  Fundamentals of Clinical Research – hands- on course for new research staff  Periodic seminars through OSP http://www.washington.edu/research/index.php?page=o spLearning 17

18. Abbreviations 101  CRBB – Clinical Research Budget and Billing  ITHS – Institute for Translational Health Sciences  OSP – Office of Sponsored Projects  DBT – Detailed Budgeting Tool  HSD – Human Subjects Division  CTP analysis – Clinical Trials Policy analysis  WIRB – Western Institutional Review Board 18

19. Abbreviations 101 - cont  HSRAC – Human Subjects Radiation Approval Committee  GIM – Grants Information Memoranda  CTA – Clinical Trials Agreement  OR – Office of Research  GCA – Grants and Contracts Accounting  EFA – Electronic Funding Action  RTS – Research Testing Service  SAGE – System to Administer Grants Electronically 19

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21.  CRBB Detailed Budget Tool  https://depts.washington.edu/crbb/Submit_Bu dget.shtml https://depts.washington.edu/crbb/Submit_Bu dget.shtml  For help contact CRBB CRBB@uw.edu 206-543-7774 21

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23. Who to go to for help  Grant and contracts questions – your Division/Departmental administrator  General questions about clinical research at the UW – Ella Mae Kurashige, Director Clinical Research Services - ellamaek@uw.eduellamaek@uw.edu  Office of Sponsored Programs - http://www.washington.edu/research/osp/?page=osp http://www.washington.edu/research/osp/?page=osp  ITHS Research Navigator - https://www.iths.org/help https://www.iths.org/help 23

24. Who to go to for help  How to get assistance from a research coordinator – Michelle Doyle – ITHS Research Coordinator Core rccore@uw.edu rccore@uw.edu  Study design and biostatistical help – ITHS Center for Biomedical Statistics http://depts.washington.edu/medstat/Welcome.html  Investigational Drug Service – Sheree Miller – uwmcids@uw.edu uwmcids@uw.edu  Research Bioethics – Ben Wilfond - ITHS RSB core rsbcore@u.washington.edu rsbcore@u.washington.edu 24

25. Who to go to for help  Research labs - Research Testing Service – rts@u.washington.edu rts@u.washington.edu  Regulatory questions – Ann Melvin, Jason Malone ITHS RSB core rsbcore@u.washington.edursbcore@u.washington.edu  Working with the UW CRC – Paul Hughes – phughes@uw.edu phughes@uw.edu  ITHS Bionutrition Core – Holly Callahan - hcal@uw.edu hcal@uw.edu  ITHS Body Composition and Exercise Laboratory– Holly Callahan - hcal@uw.eduhcal@uw.edu 25

26. 26 Additional Resources  Institute for Translational Health Sciences (ITHS) www.iths.orgwww.iths.org  Additional education http://www.iths.org/educationhttp://www.iths.org/education  UW Clinical trials handbook https://www.washington.edu/research/clinical-research- handbook//: submission checklists, repository for how to do clinical research at the UW Medicine https://www.washington.edu/research/clinical-research- handbook//  Translational Research Toolkit – UW Healthlinks: search for Translational Research Toolkit http://healthlinks.washington.edu.offcampus.lib.washington.edu/ http://healthlinks.washington.edu.offcampus.lib.washington.edu/  PRIMER toolkit - http://researchtoolkit.org/http://researchtoolkit.org/