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CCTSI Nuts and Bolts How the CCTSI Can Accelerate Your Research

Schedule . 1. Introduction: Jane Reusch2. PCIR:Bob Eckel3. Regulatory:Angela Wishon4. Biostatistics: John Kittelson5. Break out sessions6. Summary of breakout and closing remarks. Colorado Clinical

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CCTSI Nuts and Bolts How the CCTSI Can Accelerate Your Research

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    1. CCTSI Nuts and Bolts How the CCTSI Can Accelerate Your Research

    2. Schedule 1. Introduction: Jane Reusch 2. PCIR: Bob Eckel 3. Regulatory: Angela Wishon 4. Biostatistics: John Kittelson 5. Break out sessions 6. Summary of breakout and closing remarks

    3. Colorado Clinical & Translational Sciences Institute (CCTSI) Introduction to the Organization and Structure

    4. CCTSI at University of Colorado

    5. CCTSI Organizational Structure

    6. CCTSI Academic Home

    7. Discovery Translation Organization

    8. Workshop

    9. Education, Training, & Career Development (ETCD) Organization

    10. Case #1 Jr. Faculty #1 has demonstrated that milk has the ability to cure lupus in mice. She would like to investigate this in humans. With her mentor, she has put together a set of specific aims and laid out a study design. Her mentor tells her to go to that new GCRC/CCTSI thing and get the project going. “They have people there who can help you.”

    11. Questions for Case #1 Who are those people? How do you find them? How do you fill out the on-line application? What is the difference between the SARC and the IRB? Can you get someone to look over the application/project before you turn it in? How do you get help with statistics? Is there a course for this?

    12. PCIR: Organizational Structure

    13. New structure of the CTRCs (evolving see website) Centralized administration established Robert Eckel/Kristin Benn Tom Campbell / Pat Kittleson– Adult CTRC Philip Zeitler/ Cindy Scott – TCH CTRC Liz Connick/Mary Dang-UCB CTRC Donald Leong NJC CTRC Nursing – TBA (outpt Lefevre; inpt-Bilton) Bionutrition – Janine Higgins Core Laboratories – Bryan Haugen Streamlined centralized support services Centralized protocol submission process CTRC units and staff Bionutrition core Extended communication and services via the Nutrition Resource Core assay laboratories Bryan Haugen oversees consolidated core laboratory activities COMIRB approval only now possible Equitable distribution of support (up to 7,000 per protocol CTRC resources)

    14. Design and implement the PCIR Central to support clinical and translational research for investigators New local scientific review process. New Scientific Advisory and Review Committees (SARC) established. Adult – Wendy Kohrt, Ph.D and James Maloney, M.D. appointed as new co-chairs. Pediatrics – Jeff Galinkin, M.D., Ph.D. and Paul Fennessey, Ph.D. retained as co-chairs. Protocol review process Expanded investigator support services – the new CTO model In consideration, nothing implemented secondary to budget Integration with other institutional resources In progress (today) Matchmaker program In progress

    15. Case #2 Jr. Faculty #2 has just been recruited to UCD and is going to be part of an NIH multicenter trial to examine exercise and drug X on breast cancer. He needs to get all the regulatory paperwork set up in order to participate. As far as he can tell, he’s done a million online courses already.

    16. Questions for Case #2 How does he find out what coursework is needed? Is there someone who can help with an IND? How does he register with clintrials.gov? Why is the consent form so complicated? How does he set up the contracts with the drug manufacturer? Is there a course for this?

    17. Regulatory Knowledge and Support Core Angela R. Charboneau Wishon, J.D. Assistant Vice Chancellor for Regulatory Compliance Director, CCTSI Regulatory Knowledge and Support Core

    18. Overall Goals for this Program/Core Provide academic medical researchers a resource to master the complexities of regulatory issues associated with translational research; Enhance existing research support services by providing the infrastructure to efficiently manage the vast array of regulatory issues across the affiliated institutions within the region; and Assure consistent standards of human protection within our affiliated institutions.

    19. Specific Aims in CTSA Grant Provide centralized services that facilitate preparation and maintenance of regulatory and administrative requirements and streamline researchers’ interactions with regulatory agencies. Provide centralized services that provide a clinical research quality assurance program. Provide consultative expertise and serve as a regulatory resource for researchers. Provide training and be a resource for education on regulatory topics.

    20. Organizational Structure

    21. Case #3 Jr. Faculty #3 is writing a grant proposal and has no clue where to start with the statistics section.

    22. Questions for Case #3 How do you get help with a power analysis? Why would he want a statistician involved in the study before he has data? Does he just need statistical advice or does he need a statistician on the project? Is there a course for this?

    23. UCD Biostatistics and the Biostatistics, Epidemiology, and Research Design (BERD) Program of the CCTSI John Kittelson, PhD Monday October 12th, 2009

    24. Outline Overview of UCD Biostatistics Department of Biostatistics and Informatics Colorado Biostatistics Consortium (CBC) Research Institute (Pediatrics) Others BERD program Overview of infrastructure Education program Consultation/collaboration Methods development

    25. UCD Biostatistics Overview Department of Biostatistics and Informatics: Research (biostatistics methods) Teaching: Biostatistics graduate program (PhD, MS) Masters of Public Health Clinical Sciences Program

    26. UCD Biostatistics Overview Department of Biostatistics and Informatics: Collaborations: Cancer Center Pharmacy/pharmacology CAIANH COHO CHN BDC CFAR Psychiatry

    27. UCD Biostatistics Overview Colorado Biostatistics Consortium (CBC) A unit within the Department of Biostatistics Created to develop additional biostatistics resources and to prepare for CTSA application Funded through SIRC proposal 10 biostatisticians (including 4 from Pediatrics)

    28. UCD Biostatistics Overview Research Institute (Children’s & Pediatrics) A unit within the Department of Pediatrics Collaborator in the CBC 4 biostatisticians Wide-ranging collaborations in pediatric research

    29. UCD Biostatistics Overview Others Department of Family Medicine Department of Anesthesiology Division of Health Care Policy & Research

    30. Biostatistics, Epidemiology, and Research Design (BERD) Program: A collaboration across 10 groups: Biostatistics Dept. Epidemiology Dept. Pediatrics Dept. COHO School of Pharmacy College of Nursing National Jewish CAIANH CO Prevention Center Kaiser Permanente BERD Program

    31. Broad Objective: To build breadth and depth through collaboration

    32. Broad Objective: To build breadth and depth through collaboration

    33. Broad Objective: To build breadth and depth through collaboration

    34. Broad Objective: To build breadth and depth through collaboration

    35. Education Program Biostatistics short courses for non-statisticians Data analysis short course Study design short course (in planning) Education seminar series (3-4pm last Monday of most months) Continuing education for biostatisticians: Pharmacokinetic methods short course Workshop on non-inferiority trials Clinical trial design short course Note formal courses in Biostatistics Dept: Bios 6601/6602: Biostatistics I/II (non-statisticians) Bios 6611/6612: Applied biostatistics (statisticians) Bios 6648: Clinical trials

    36. Consultation/collaboration BERD program supports: CCTSI Trainees (e.g., K-12 awardees) CCTSI pilot grant awardees CCTSI-supported studies on the CTRC [Note: limitations apply] Process: Register your project at http://cbc.uchsc.edu Statisticians meet weekly to review new work

    37. New methods in translational statistics: “To advance the methodological aspects of translational research through original biostatistical methods research (including novel study design methods).”

    38. Recap of breakout results Closing

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