1. Easing the Burden on the Clinical Site
Kathy Kioussopoulos, RN
Director, Interventional Cardiology Clinical Research
University of Colorado Health Sciences Center
March 24, 2007

2. Challenges for the Clinical Site
A majority of clinical trial budgets are paid on a “per patient” fixed fee
Very difficult to predict patient enrollment
The site must maintain study personnel in order to staff the study
Payments only happen after enrollment and monitoring
Sites end up supporting the start-up costs for the study

3. How involved are you in the budget process for the trials done at your site?
Very involved
Somewhat involved
Not at all involved
Does not apply

4. How involved are you in the budget process for the trials done at your site?
Very involved
Somewhat involved
Not at all involved
Does not apply

5. Sample Device Study Early Phase Pivotal Device Trial
Projected enrollment of 20 patients
Average per-patient payment to site: $12,800
Required study visits: one outpatient hospital visit with device implant
Pre-implant clinic visit
One follow-up clinic visit at one year

6. Sample Device Budget Direct Costs $ Amount Personnel
Salaries and Wages
$31,377
Benefits
$9,099
Hospital Patient Care Cost
$205,000
IRB Review
$1,800
Other Expenses
Total Direct Costs
$247,276
Institutional Overhead (indirect costs)
$10,523
Total Direct/Indirect Costs
$257,799

7. Sample Phase II Outpatient Drug Trial
Per patient amount: $4,964
Projected enrollment of 20 patients
Required visits include 10 clinical visits (including 2 phone contacts)

8. Sample Drug Trial Budget (Phase II Outpatient Study)
Direct Costs
$ Amount
Personnel
Salaries and Wages
$18,260
Benefits
$5,296
Hospital Patient Care Cost ($3,390/pt)
$67,800
IRB Review
$1,800
Other Expenses
Total Direct Costs
$93,156
Institutional Overhead (indirect costs)
$6,125
Total Direct/Indirect Costs
$99,280

9. How much coordinator time does this buy?
Device Study
$40,476 (annual salary and benefits)
= 913 hours for 20 patients, or 46 hours per patient
Phase II Drug Study
$23,556 (annual salary and benefits)
= 531 hours for 20 patients, or 27 hours per patient

10. Clinical Workday Assumptions
Study Visits (average 1 hour/visit)
Non-Study and Screening Clinic Visits
No-Show Clinic Appointment

11. Which of the following causes you the most frustration?
Monitor/CRA turnover
CRF/eCRF completion
Protocol amendments
SAE reporting
Trial-specific conference calls
Other

12. Which of the following causes you the most frustration?
Monitor/CRA turnover
CRF/eCRF completion
Protocol amendments
SAE reporting
Trial-specific conference calls
Other

13. Administration and Support Study Coordinator Tasks
Daily Tasks
CRF completion—2 hours /day
Phone, fax, and/or —1 hour/day

14. Weekly Tasks Sponsor’s CRA monitoring visits
Patient recruitment /chart review
Lab shipments for study supplies
Protocol review and staff meetings
Data corrections/data queries
Regulatory documents/IRB correspondence
Collect and process AEs
Read and implement protocol amendments
Read and comment on new protocols
Administer and explain informed consents

15. Monthly Tasks Site qualification visits Site initiation visits
Site closeout visits
In-services for hospital staff
Filing of documents
Ordering study supplies

16. Other Challenges

17. Regulatory Challenges for the Clinical Site
Local IRB (annual training requirements for staff)
Local Hospital Review committee—Veterans Administration Hospital versus University Hospital (annual compliance training requirements for staff)
FDA-NIH regulatory compliance (how does site stay current?)

18. Study Management
How do you maximize staff productivity and site viability?

19. Which of the following resources could be most helpful to you in resolving your challenges?
Tools and Templates (i.e. budget, AE/SAE reporting guidelines, SOP, etc.)
Training (Keys to building a successful research site, GCP, etc.)
Ongoing discussion forums (online, sc symposia, etc.)
All of the above
Other

20. Which of the following resources could be most helpful to you in resolving your challenges?
Tools and Templates (i.e. budget, AE/SAE reporting guidelines, SOP, etc.)
Training (Keys to building a successful research site, GCP, etc.)
Ongoing discussion forums (online, sc symposia, etc.)
All of the above
Other

21. Creating, Implementing, and Sharing Best Practices for Clinical Trials Networks
Implement programs and tools to build site capability for the recruitment, retention, and performance of clinical research sites
Professional development at the site
Standardized tools to accelerate trial timelines
Tracking and benchmarking of site metrics to improve performance and accountability

22. Building and Expanding Site Capability
Certification/training in protection of human subjects
Comprehensive program on good clinical research practices
Evidence-based medicine educational series
Practice of conducting trials
Yearly symposia and network e-newsletters
Access to DCRI research conferences
Clinical research writing education series

23. Background: Clinical Research Problems & Gaps
Site Capability
Fundamentals of clinical research
Human subjects protection training
Good clinical research practice
Site Work “Tools”
Budgets
Contracts
Recruitment/timelines
Productivity metrics

24. Building Site Capability and Performance
Dynamic Web page constructed with Study Coordinator Advisory Committee, delivering high-quality education tools for sites to access
GCP
Lessons from a Horse Named Jim
Human Research Subject Protection
Keys to Building a Successful Research Site
Templates: SOPs, Source Documents
E-newsletters
DCRI Research Conference
Evidence-Based-Medicine Educational Series
Writing Series (abstracts, protocols, substudies, manuscripts)

25. Study Coordinator Advisory Committee
Purpose
To provide expert advice, feedback, and guidance to the CTNBP management team on the implementation of program deliverables as they pertain to clinical research (site) networks

26. Responsibilities
Develop strategies for ensuring successful collaboration between intradisciplinary network team members.
Provide guidance on the planning, development, and delivery of educational materials and programs for use by the networks.

27. Responsibilities
Act as site advocates to encourage abstract and journal publications specific to CTNBP networks.
Recommend strategies to improve the overall conduct of clinical research trials by network sites.

28. Study Coordinator Advisory Committee
Black Hill CRC
St. Mary’s Medical
Genesis Health Care
Penn State
Hershey Medical
Univ. of Colorado
Duke
Methodist Hospital
The Heart Center
Study Coordinator Advisory Committee

30. Sample Study Budget

31. “Study Coordinators Hidden Costs” –Budget Considerations
Patient Screening Costs –
a. Talking to patients and families
b. Mailing consents and materials
c. Follow up on phone call and mailed consents (time!)
d. Screen Failures and randomization failures (partial payment)
Serious Adverse Event Follow up
a. Getting medical records and data
b. Follow up with patient and extra follow up
c. Time reporting requirements dictate fast turn around(prioritization)
Sponsor Audits/FDA Audits
a. On site visits
b. Lengthy monitor visits

32. “Study Coordinators Hidden Costs” –Budget Considerations
Misc Supplies
a. Dry ice
b. Copies, faxes, mailing (some places may be able to use their overhead for this)
c. Internet connectivity – e.g.; some studies want a dedicated line for their equipment.
Queries!
a. Some studies can generate 100’s of these and they dictate a turn around time that can be difficult to manage
b. Query resolution can impact your reimbursement
c. Does the PI have to sign off on the query? Can affect your turn around time….
d. Getting queries months after a study has closed or finished!

33. Recommended Strategies
Negotiate an up front payment ( ask for all start up costs up front and include two patient payments in advance.)
Review the CRF in advance (see if time provided and payment matches what would actually take)
Review protocol carefully to determine what is standard of care for your site (ex: labs, ecg’s, clinic appointments) and make sure these items are included as a line item in your protocol.
Don’t let more than one monitor come at a time, you should dictate how much of your coordinator time they get, not them. Pre-specify prior to the visit that you will give them a set amount of time during the visit.
Negotiate a line item budget for the screen failures and non randomized patients