1. Clinical Trials Budgeting

2. Objectives Demystify clinical trials budgeting
Increase preparer’s understanding and comfort level with financial aspect of clinical trials
Provide tools to develop a consistent approach to budgeting

3. Industry Sponsored v. Grants
Subject to different sets of regulations
Industry sponsored projects are not capped; they do not begin with a pool of funds that are drawn down
More freedom to negotiate; not typically a “take it or leave it”
At minimum, need to cover costs, but it’s ok to do a little better than cover costs

4. Overview We are going to look at budgeting by looking at
two types of studies:
Study with Patient Charges
Registry/Observational Study
Examples of actual protocols will be used to
illustrate various issues that arise in budgeting.

5. Ex. 1: Study with Patient Charges
1. Start with reviewing Final Protocol
*Look at Schedule of Visits; Schedule of Procedures
2. Break down each procedure into component parts
3. Identify all costs CMH will incur
4. Add in personnel time
5. Compare to sponsor’s offer

7. How do I determine what CMH’s costs are?
Assessments – ask: who and how long?
Labs – Is CMH only collecting and preparing samples to send out? Or running test here? If using our lab, request pricing from lab
Patient Charges
Get CPT codes (from protocol, sponsor, PI or administrator)
Ask Kris or CRU (if planning on using CRU)
Will you need report/interp. or is there central reader?
PI & CRA fees – need to calculate number of hours to be spent on study and multiply by hourly rate plus 26% fringe. OSP can help with salary info.

8. The EGD/biopsy
….. EGD/biopsy indicated as SOC, but study requires it within a specific window (within 6 weeks of BLV). So, we still need to determine a price in case patient has no insurance or it will not be considered SOC, etc.

10. As it turned out… Endoscopy Costs included: Pharmacy $245
Operating Room $1171
Anesthesia $585
Recovery Room $1272
Medical Supplies $186
Physician Pro Fee $1596
Anesthesia Pro Fee $927

11. For a grand total of…
$5,982.00!*
It can be very costly to miss charges!
*This study began before EPIC research pricing established.

12. How will I know all the charges a procedure requires?
Ask PI or Dept. Administrator what charges are typically included in procedure
Refer to studies conducted in the past
Find patient(s) that has had procedure recently and check what codes were billed
Ask yourself or PI/Administrator if sedation generally required, ancillary labs or pathology
Most important thing is to get in the habit of asking the questions, because there are resources available to help!

13. Personnel
Calculate number of hours each key person will spend per patient or per visit
Also total number of hours spent preparing for and conducting study:
Investigator meeting/Teleconferences/Travel/Training
Department Meetings
Subject Population Prescreen (do we have pts that qualify)
IRB prep & submission (protocol review, letters of support)
Phone calls re study/ Feasibility surveys
Initiation Visit and Subsequent Monitoring Visits
Subject visits, Data Entry

14. Compare to Sponsor Budget
Compare your notes from review of protocol along with CMH costs to the compensation offered by the sponsor

16. Registries or Retrospective Studies
These studies appear easier to budget because the costs are “soft”, i.e. primarily personnel
It can be tempting to simply accept the sponsor’s budget, but go through the same process as clinical trials

19. Things to Consider…
If questionnaire is involved, how long is the questionnaire? Is it easy to read and follow? Is it manual or electronic?
Will you be required to de-identify medical records? Are they in EPIC or on paper?
Adverse Events Monitoring and Reporting (of medical adverse events)
Storage Related Costs: Record retrieval, copy, travel, etc

20. Tools Clinical Trial Budget Template
CMH Cost v. Sponsor Offer Worksheet

24. Checklist Start with Final protocol
Copy of/access to CRF, questionnaires, etc.
Monitoring – How often? By CRO or sponsor?
Subject Population – will advertising be necessary? Will it be easy or difficult to enroll subjects?
Identify CMH fixed costs: labs, procedures, room fees, pro fees, CRU, pharmacy, supplies, etc
How much PI/CRA/nurse/admin time required
Preparation – Investigator meetings, department meetings, phone calls, feasibility, IRB

25. Questions? Kristine Martens, JD Assistant Director
Office of Sponsored Programs
Ann & Robert H. Lurie Childrens’ Hospital of Chicago
225 E. Chicago Ave., Box 205
Chicago, IL 60611