Transcript Regulatory Support and Bioethics Core

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
2
Study feasibility







Population
Procedures
Collaborations
Staff
Budget
Space
etc.
3
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?
5
Collaborations


Do you need additional specialists?
Do you need access to outside
clinics/schools/etc?
6
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?
7
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.
9
Space

Do you have room for:





Research personnel
Study binders
Any equipment needed
Lab supplies OR
Will you have to look for more space?
10
Start up activities - contracts

Read the protocol


Decide if the study is feasible


Make sure everyone on the research team reads
the protocol
Will study change clinical practice?
Let your Division/Departmental administrator
know you are thinking of pursuing/accepting
the contract
11
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?
12
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

13
https://www.washington.edu/research/clinical-research-handbook//
Study start up activities – training


Investigator training
Staff training
14
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
15

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
16
Additional educational options



ITHS CRES – Clinical Research Education
Series – monthly seminars on topics relevant
to clinical and translational research
Fundamentals of Clinical Research – handson course for new research staff
Periodic seminars through OSP
http://www.washington.edu/research/index.php?page=o
spLearning
17
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
18
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
19
20



CRBB Detailed Budget Tool
https://depts.washington.edu/crbb/Submit_Bu
dget.shtml
For help contact CRBB


[email protected]
206-543-7774
21
22
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
23
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
 Investigational Drug Service – Sheree Miller –
[email protected]
 Research Bioethics – Ben Wilfond - ITHS RSB core
[email protected]

24
Who to go to for help





Research labs - Research Testing Service –
[email protected]
Regulatory questions – Ann Melvin, Jason Malone
ITHS RSB core [email protected]
Working with the UW CRC – Paul Hughes –
[email protected]
ITHS Bionutrition Core – Holly Callahan [email protected]
ITHS Body Composition and Exercise Laboratory–
Holly Callahan - [email protected]
25
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-researchhandbook//: 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/
26