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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

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
Objectives
  • Provide an overview of:
    • How to assess study feasibility
    • Clinical research approval process- UW
    • Where you can go for help
study feasibility
Study feasibility
  • Population
  • Procedures
  • Collaborations
  • Staff
  • Budget
  • Space
  • etc.
population
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?
procedures
Procedures
  • Are procedures approvable?
  • Are procedures frequent/painful/inconvenient?
  • Do procedures require special equipment/expertise?
collaborations
Collaborations
  • Do you need additional specialists?
  • Do you need access to outside clinics/schools/etc?
personnel
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?
budget considerations
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
budgets
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.
space
Space
  • Do you have room for:
    • Research personnel
    • Study binders
    • Any equipment needed
    • Lab supplies OR
  • Will you have to look for more space?
start up activities contracts
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
considerations if you didn t write the protocol
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?
study start up activities develop all study materials
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//

study start up activities training
Study start up activities – training
  • Investigator training
  • Staff training
training requirements
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
training requirements1
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
additional educational options
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

abbreviations 101
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
abbreviations 101 cont
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
slide21
CRBB Detailed Budget Tool
  • https://depts.washington.edu/crbb/Submit_Budget.shtml
  • For help contact CRBB
who to go to for help
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 - [email protected]
  • Office of Sponsored Programs - http://www.washington.edu/research/osp/?page=osp
  • ITHS Research Navigator - https://www.iths.org/help
who to go to for help1
Who to go to for help
  • How to get assistance from a research coordinator – Michelle Doyle – ITHS Research Coordinator Core [email protected]
  • Study design and biostatistical help – ITHS Center for Biomedical Statistics

http://depts.washington.edu/medstat/Welcome.html

who to go to for help2
Who to go to for help
additional resources
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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