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/