Budgeting for Industry Sponsored

Clinical Trials

Shannon Parham
Office of Research and
The Clinical Research Program
 Objectives
• Identify your resources
• Describe associated costs
• Demonstrate how to write a internal
budget
• Identify hidden costs
• Identify the elements of sponsor’s budget
• Describe post award activities related to
payment and budget changes
 When to start
• Ask the sponsor for a draft budget and
protocol as soon as you are approached
for the trial.
– The budget and contract can take as long to
negotiate as the Informed Consent Document
– You can make a draft budget while waiting on
the sponsor’s budget
 Identify your Resources
• UMC Office of Research, 5-5000
– Budget and Contract Negotiation
– Mentoring
• UMC Grants and Contracts, 4-1040
– Establishing accounts
– Account management
• Protocol and Protocol Schematic
• Department Charge Masters
 Identify Your Costs
• Study the protocol carefully
– Is the research right for your site
• Interest
• Resources
• Research staff
• Patient population
• Review the Protocol Schematic and
Informed Consent Document
 Review the Protocol Schematic
• Hospital procedures
• Physician practice costs
• Lab costs
• How many visits / Length of study
• Visits until randomization
• Length of coordinator procedures
• Staff training
 Build the Budget
• Per Patient Costs
• Study Level Costs
 Per Patient Costs
• Breakdown procedures by Coordinator,
Physician, and Hospital Fees
– Lab draws / Lab review
– ECHO (obtain) / ECHO review
– Medical History (obtain / review)
• Assign costs to procedures
• Indirect Cost
– 26% Industry Sponsored Trials
 UMC Budget

Study Period Washout Screening Double-blind Treatment Period

Visit 1 2 3 4 5 6 7 8
PROCEDURES: Cost -21 -14 1 7 14 28 42 56 Totals
Informed Consent $75 $75 $75
Inclusion/Exclusion Criteria $25 $25 $25 $25 $75
Taper AntiHyp Meds $40 $40 $40
Medical History (inc. Hyp & Smoking $85 $85 $85
Height/ Weight $15 $15 15
Waist Circumference $15 $15 $15
BP and Pulse $25 $25 $25 $25 $25 $25 $25 $25 $25 $200
Screening PE $125 $125 $125
Complete PE $175 $175 $175 $350
EKG $63 $63 $63 $63 $189
EKG Interpretation $37 $37 $37 $37 $111
Collect Labs $25 $25 $25 $25 $25 $100
Lab Interpretation $25 $25 $25 $25 $25 $100
Pharmacogenetic Consent $25 $25 $25
Adverse Events $20 $20 $20 $20 $20 $20 $20 $20 $140
Concomitant Medications $15 $15 $15 $15 $15 $15 $15 $15 $15 $120
Drug Accountability $25 $25 $25 $25 $25 $25 $25 $150
IVRS $40 $40 $40 $40 $40 $160
Screening Log $25 $25 $25
Randomization $25 $25 $25
Dispense Study Meds $20 $20 $20 $20 $60
Echocardiagram $40 $40 $40
Pt Reimbursement for Travel $25 $25 $25 $25 $25 $25 $25 $25 $25 $200
Coordinator Fee: $60 $60 $60 $60 $60 $60 $60 $60 $60 $480
Total per procedure $650 $230 $660 $230 $170 $220 $170 $575 $2,905
Institutional overhead 26% $169 $60 $172 $60 $44 $57 $44 $150 $755
Total w/ overhead $819 $290 $832 $290 $214 $277 $214 $725 $3,660
9 Patients: $32,942.70
 Coordinator Fee
• Regulatory
• Investigator binders/files
• Faxes/emails
• Conference Calls
• Case Report Forms
• Scheduling for pt visits, tests/scans
• Subject payments / reimbursements
• Data query resolution
• Track study payments
 Study Level Costs
• Screen Failures
• Study Initiation
• Electronic Data Capture Training
• Advertising / Recruitment
• IRB Fee
• Pharmacy Set Up Fee

cont’d on next slide

 Study Level Costs (cont’d)
• Storage
• Unscheduled visits
• SAE reports
• Endpoints
• Monitor visits
• Additional IRB submissions
 UMC Budget

STUDY LEVEL COSTS:

Screen Failures Maximum of 6 Failures at $1,108.80 $6,652.80
Electronic Data Capture Support 24 hours at $40.00 per hour $960.00
Advertising/Recruitment $3,000.00
Study Initiation $3,250.00
IRB Fee $2,000.00
Unscheduled Visits 13 visits per patient, up to: 9 patients at $85.00 per visit $9,945.00
Pharmacy Set Up Fee $500.00
Storage Fee $450.00
TOTAL INVOICED COSTS: $26,757.80
 Study Period Double-blind Treatment Period
Visit 1 2 3 4 5 6 7 8
PROCEDURES: Cost -21 -14 1 7 14 28 42 56 Totals
Informed Consent $75 $75 $75
Inclusion/Exclusion Criteria $25 $25 $25 $25 $75
Taper AntiHyp Meds $40 $40 $40
Medical History $85 $85 $85
Height/ Weight $15 $15 15
Waist Circumference $15 $15 $15
BP and Pulse $25 $25 $25 $25 $25 $25 $25 $25 $25 $200
Screening PE $125 $125 $125
Complete PE $175 $175 $175 $350
EKG $63 $63 $63 $63 $189
EKG Interpretation $37 $37 $37 $37 $111
Collect Labs $25 $25 $25 $25 $25 $100
Lab Interpretation $25 $25 $25 $25 $25 $100
Pharmacogenetic Consent $25 $25 $25
Adverse Events $20 $20 $20 $20 $20 $20 $20 $20 $140
Concomitant Medications $15 $15 $15 $15 $15 $15 $15 $15 $15 $120
Drug Accountability $25 $25 $25 $25 $25 $25 $25 $150
IVRS $40 $40 $40 $40 $40 $160
Screening Log $25 $25 $25
Randomization $25 $25 $25
Dispense Study Meds $20 $20 $20 $20 $60
Echocardiagram $40 $40 $40
Pt Reimbursement for Travel $25 $25 $25 $25 $25 $25 $25 $25 $25 $200
Coordinator Fee: $60 $60 $60 $60 $60 $60 $60 $60 $60 $480
Total per procedure $650 $230 $660 $230 $170 $220 $170 $575 $2,905
Institutional overhead 26% $169 $60 $172 $60 $44 $57 $44 $150 $755
Total w/ overhead $819 $290 $832 $290 $214 $277 $214 $725 $3,660
9 Patients: $32,942.70
STUDY LEVEL COSTS:
Screen Failures Maximum of 6 Failures at $1,108.80 $6,652.80
Electronic Data Capture Support 24 hours at $40.00 per hour $960.00
Advertising/Recruitment $3,000.00
Study Initiation $3,250.00
IRB Fee $2,000.00
Unscheduled Visits 13 visits per patient, up to: 9 patients at $85.00 per visit $9,945.00
Pharmacy Set Up Fee $500.00
Storage Fee $450.00
TOTAL INVOICED COSTS: $26,757.80

Total Requested: $59,700.50

 Study Initiation ($1500 - $5000)
• Protocol Review
• Site Initiation
• Contract and Budget Review
• Investigator Meeting
• Regulatory Documentation
• Initial IRB Application (23 pages)
• Informed Consent Document
– IRB Requested Revisions
– Negotiating ICD w/ Sponsor
• Copy Charges / Office Supplies
 In clinical research, a site needs to anticipate that
the time and effort necessary to successfully
complete a study will be significantly greater than it
would be to treat a similar number of regular-practice
patients. It (the site) must negotiate a budget that
provides adequate reimbursement for that extra time
and effort.”

The Investigator’s Guide to Clinical Research

Dr. David Ginsberg
Centerwatch
Review the sponsor budget….

Remember – every company, every

protocol, is different.
 The Sponsor’s Budget
• Is the Per Patient Amount comparable
• Is the overhead correct
• How many patients are allowed
• Are your Study Level costs covered
• Review the terms
• Decide if you can live with it
 Negotiate with the Sponsor
• The office of research can negotiate your
trial budget for you.
• Sometimes it is better to have a “Middle
Man”
• Keep the Office of Research informed
about budget changes
 Negotiating
• Perform a cost analysis and report this to
the sponsor
• The internal budget procedure costs can
differ from sponsor budget
 Sponsor Payment Terms
• What is the payment schedule
– Quarterly
– Annually
– After Monitor Visits
• Are they relying on you to Invoice
– For all payments
– Study Level Costs
• What is the initial payment
Blank invoice – O/R website
University of Mississippi Medical Center Invoice #
Your Division Name
Your Division Address Phone:
Address Line 2 Fax:

INVOICE

Sponsor
Name: Date:
Protocol #:
Address: Study Title:
City: State: ZIP: PI:
Phone:

Date Qty Description Unit Price TOTAL

$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
Total $ -

Payment Details:
Check
Payable TO: University of Mississippi Medical Center
Address: ATTN: Charles Mullen, Comptroller
2500 North State Street
Jackson, MS 39216-4505
Tax ID: 64-6008520
Check must reference Study Name and PI

Please send payment within 30 days of invoice. Thank You.

 Hidden Costs
• Delayed start / ICD process
• Pre-screening
• Increased hospital procedure costs
• Unscheduled visits
• Tracking study funds
• Query resolution
• Amendments
 Increased Hospital Procedure
Costs? - renegotiate
• Increase cost of Stress Tests
Year UMC Cost UIMA Cost Total Cost
00/01 $198.00 $175.00 $373.00

01/02 $198.00 $175.00 $373.00

02/03 $224.00 $175.00 $398.00

03/04 $397.00 $184.00 $581.00

04/05 $417.00 $184.00 $601.00

 Re-Negotiation is an Option
• If the Protocol is amended…
– If the amendment changes work load or adds
procedures … re-negotiate
• Example: 5 yr study, Monthly pt phone calls added
(20 patients/60 calls)
• Amended contract for $20,880.00 ($25.00/call)
• If sponsor allows more patients to be
enrolled, request more screen failures
 Track your payments
• Budget statement
• Payment memo
• Invoice for your “Study Level Costs” and
reimbursable expenses
• Sponsors miss payments
• UMC Grants/Contracts office can make mistakes…
– Check the Indirect deducted
– Are you waiting on a check
• Some sponsors rely on you to invoice for all the
visits.
 Figuring Indirect
Using the Total (including indirect)
Divide by 1.26 = Direct (spendable dollars)
Subtract Direct from Total = Indirect

$5000 /1.26 = $3968.25 direct

$5000 - $3968.25 = $1031.75 indirect
“…providing/receiving grant payments
is the single most inefficient activity in
study conduct.”

ACRP White Paper

(survey of 1100 clinical research professionals)
 Office of Research
5-5000

Grants and Contracts

4-1040