clinical trials: how do i get started? osp brown bag session march 16, 2012 ann j. melvin md, mph...
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Clinical Trials: How do I get started?
OSP Brown Bag SessionMarch 16, 2012Ann J. Melvin MD, MPHCo-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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Study feasibility
Population Procedures Collaborations Staff Budget Space etc.
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
Procedures Are procedures approvable? Are procedures
frequent/painful/inconvenient? Do procedures require special
equipment/expertise?
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Collaborations Do you need additional specialists? Do you need access to outside
clinics/schools/etc?
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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?
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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
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.
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Space Do you have room for:
Research personnel Study binders Any equipment needed Lab supplies OR
Will you have to look for more space?
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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
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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?
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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 logITHS forms - www.iths.org/forms
https://www.washington.edu/research/clinical-research-handbook//
Study start up activities – training Investigator training Staff training
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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
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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_h
ipaa.html
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 OSPhttp://www.washington.edu/research/index.php?page=ospLearning
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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
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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
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CRBB Detailed Budget Tool https://depts.washington.edu/crbb/Submit_Bu
dget.shtml For help contact CRBB
CRBB@uw.edu 206-543-7774
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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
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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 24
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 25
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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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