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Clinical Trials: How do I get started?

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

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Clinical Trials: How do I get started?

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  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

  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?

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

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

  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?

  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

  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.

  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?

  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

  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?

  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 https://www.washington.edu/research/clinical-research-handbook//

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

  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/ • CRBB: • UW Medicine Clinical Trial Policy • Clinical Research Staff

  16. Training requirements • Good Clinical Practice • Required by some NIH consortia • Required by FHCRC • On-line at CITI • http://www.citiprogram.org/ • HIPAA • http://www.washington.edu/research/hsd/faq_hipaa.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=ospLearning

  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

  19. Abbreviations 101 - cont • HSRAC – Human SubjectsRadiation 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

  20. CRBB Detailed Budget Tool • https://depts.washington.edu/crbb/Submit_Budget.shtml • For help contact CRBB • CRBB@uw.edu • 206-543-7774

  21. 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.edu • Office of Sponsored Programs - http://www.washington.edu/research/osp/?page=osp • ITHS Research Navigator - https://www.iths.org/help

  22. Who to go to for help • How to get assistance from a research coordinator – Michelle Doyle – ITHS Research Coordinator Core 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 • Research Bioethics – Ben Wilfond - ITHS RSB core rsbcore@u.washington.edu

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

  24. Additional Resources • Institute for Translational Health Sciences (ITHS) www.iths.org • Additional education http://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 • Translational Research Toolkit – UW Healthlinks: search for Translational Research Toolkit http://healthlinks.washington.edu.offcampus.lib.washington.edu/ • PRIMER toolkit - http://researchtoolkit.org/

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