CRC Basic 2.0
Budgeting for
Industry-Sponsored
Clinical Trials
Julie Calahan, CCRP
Clinical Trials Budget Analyst
Health System Contracts Office
1
Clinical Trials Contracts Office
Annie Wong – Health System Contracts Director
Signatory and Director of Clinical Trials unit
Erick Jenkins – Clinical Trials Officer
Supervises Clinical Trials unit, negotiates new and complex clinical
trial agreements and assists in negotiation of UCOP master
agreements, liaison with UC Office of the President and CTSC
Andrew Jones – Clinical Trials Analyst
Negotiates agreements under master clinical trial
agreements and some new agreements
Lorie Dilts – Clinical Trials Analyst
Negotiates amendments and confidentiality agreements,
office and database management
Julie Calahan – Clinical Trials Budget Analyst
Assists departments with budget development and
negotiation, develop clinical trial budgeting policy
Objectives
 Roles of coverage analysis and internal budget
 Components of a clinical trial budget
 Budget template and examples
 Budget negotiation tips and tactics
 Resources and questions
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What is a clinical trial?
(for the purposes of application of 26%
indirect rate*)
The controlled, clinical testing in
human subjects of investigational new
drugs, devices, treatments, or
diagnostics, to assess their safety,
efficacy, benefits, costs, adverse
reactions and/or outcomes.
*This rate applies to the Total Direct Cost, and
no budgeted item is excluded from the
application of indirect. This rate applies
regardless of whether a Clinical Trial is based on
sponsor -initiated, or an investigator-initiated
protocol.
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Industry Sponsored Clinical Trial Approval Process
Receive Sponsor
Packet
(Protocol, CTA &
Budget)
Assistance provided by
Research Abstractor
and Budget Analyst
PI Interest
Send Sponsor Packet to Clinical
Trial Budget Analyst and Research
Abstractor
Research Team Drafts Internal Budget (UBT)
1)Gather information from
Research Team Members (CRC, PI)
Quantim
Investigational Drug Services
Other Depts (CCRC, Radiology, Pathology)
2) Use Research Query Tool for current research prices
3) Complete Coverage Analysis
Negotiate
Budget &
Payment Terms
w/Sponsor
(External Budget)
Research Team determine feasibility:
-Scientific Merit
-Financial Soundness
-Pt Accrual
No
Tabled
Send packet to
Chair for Approval
& Signature
Clinical Trial Contract Packet
Forwarded to Dean’s Office
for Signature
Yes
CT Contracts Office
- Negotiates Contract
Language
- Signs Off on Final Budget
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The role of Coverage Analysis
(CA) and internal budget (UBT)
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Coverage Analysis Works To Create
Accurate Budget
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How can I use Coverage Analysis?
• Use to create an accurate budget
• Provides a list of study events in a Billing Grid
• Early analysis will:
• Identify all procedures
• Identify CPT codes for research costs
• Identify policies limiting insurance coverage
• CTSC Coder provides assistance
• Obtain research costs by CPT code
• Cost Query Tool
• Accurate costs=accurate budget
• Accurate budgeting useful for feasibility, negotiations with sponsors,
patient billing, invoicing
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Study Procedure/Labs
Complete Physical
Examination
(includes vital
signs/height/weight at
screening)
Physical Examination
(includes vital
signs/weight)[SOC]
CPT Code
Screen C1
Q0/Q1 ing
99201-99205,
99211-99205
Q1
99201-99205,
99211-99205
Q1
99211
Q1
N/A
N/A
C2 C3 C4 C5 C6 C7 C8 C9 C10 C13 C1 C19 C2 C25
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2
P
Shortterm LongEOT FU term FU
P
P
P
P
P P
P
P
P
P
P
P
Vital signs prior to treatment with study medication is
reasonable and necessary for patient safety.
P
MUGA Scan (or ECHO if
MUGA not available)
78472 (93306)
S
S
S
Complete physical exam at screening and end of
treatment are reasonable and necessary for work-up
prior to treatment and for assessment of potential
complications upon completion of treatment.
Physical exam each cycle is reasonable and necessary
for assessment of potential complications and/or clinical
signs of disease progression during treatment.
P P P
Vital Signs/Weight
ECOG Performance Status
Notes
S
S
S
S
S S
S
S
S
S
S
S
S
S
S S S
S
S
S
S
Use the BG to prepare internal budget
•Look up clinical trial costs by CPT code in Cost Query Tool
•Base External budget on internal budget
•Negotiate with sponsors
•Billing, CTA, Consent Form match
This is a data collection activity and is payed for by the
sponsor.
Sponsor to pay for this activity. MUGA not billable to 3rd
party for screening purposes and in the absence an
abnormal ECG (LCD L28246 01/01/2010).
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Medicare National Clinical Trial Policy
• Coverage Analysis is a UC requirement for all studies with patient
care services billed through UCDMC
• At UC Davis we can determine when a clinical trial meets national
policy guidelines by performing a Coverage Analysis
• NCD explicitly defines coverage of clinical trial services
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What does sponsor pay for?
What does 3rd party (Ins co) pay for?
Research
costs
Sponsor
Insurance/Medicare/Pt Acct
needed to clinically manage pt care
Expanded costs
Insurance/Medicare/Pt Acct
services pt receives if not in CT but part of protocol – SOC
Conventional Care Costs
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Billing Grid continued…
•
•
•
•
•
•
Tool to create an accurate budget
Identify the study events
Lists study events in the form of a CPT code
Research Costs can be found by CPT code
Lists who will be billed (sponsor or insurance billing)
Tool to reconcile billing statements
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Components of a clinical trial
budget
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Start-up Costs
Start Up
Close Out
Categories of tasks
Protocol-related tasks
Budget-related tasks
IRB Docs
Training
Pharmacy communication
Communications w/Sponsor
FEES
Advertisement
Office supplies
Pharmacy start-up, inventory
Translation of Informed Consent
Invoicables Per Patient
Tasks
Complete Feasibility Questionnaire from Sponsor
Review protocol & study flow
Review by Scientific Review Committee (Cancer Ctr)
Preparation and return of Sponsor/Site documents
Pre-Study Site Selection visit, prepare for & attend
Prepare, distribute, collect and copy financial disclosures
Obtain and copy CV's
Preparatory Research
CMS determination
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Close Out Costs
Start Up
Close Out
Invoicables Per Patient
Tasks
Closeout Report
Complete Queries
Box up Study Records
Transport Study Records for storage
Closeout Visit, Prepare for & Attend
Regulatory close with IRB
Close out study account w/Extramural (incl.payroll
transfer)
Close out invoicing
Producing addtl information after study close out
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Invoicable Costs
Start Up
Close Out
Invoicables Per Patient
Categories of Tasks
Mods to Reg Documents
Regulatory Binder, Maintain
IRB, Communicate
Modifications, incl 1572
Contracts, Communicate
Modifications
Adverse events x 8
Monitoring Visits x2
Screen Failure
x4
Annual Report
x1
IRB Docs
x1
Admin/Correspondence x1
Invoicables may or may not happen
Each category multiplied by the number of occurrences
Must include to come up with the total budget
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Per Patient Costs
Start Up
Close Out
Invoicables Per Patient
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Unified Budget Template
(UBT)
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Internal Budget (UBT) Summary
Shows anticipated revenue residuals/loss assuming full enrollment of patients
completing entire study
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Factors impacting budgets
• Composition of research personnel
• The type, phase, and complexity of the protocols involved
• Screen failure rates
• The actual time it takes to perform the work
•
Given the organization of clinical trial research services within the research unit
• Anticipated complications
•
•
•
•
Sample processing and/or shipping logistics
Patient treatment logistics and scheduling challenges
Data management in busy studies
Time limits on patient accrual reporting and data query resolution
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Start-up Costs
If you don’t ask for it, you won’t get it
Start-up fees should always be nonrefundable
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Close-Out and Other
Invoicables
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Per Patient Costs – Study Procedures/Labs
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Per Patient Costs - Other
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Per Patient Costs - Study Activities
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Per Patient Costs
Salary Calculator linked to all costs
throughout the
budget
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Completed UBT
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Budget Negotiations
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Budget negotiations……
• Sponsor’s initial budget is STARTING POINT for negotiations
(perform a thorough analysis of the specific protocol)
• Keep in mind ……all sponsors and CROs have a business plan to
make money
• Communicate resources available to conduct trial
•
•
•
Expertise
Facilities
Access to large patient population
• Remain neutral…establish that you represent the University and are
negotiating the budget on behalf of the study team
• A break-even point and bottom line should be determined
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Budget negotiations (con’t)…..
• Keep the PI in your corner
•
•
•
Keep him/her informed
Ready to intervene
Ready to remind sponsor of the benefits of having UCD as a site
• Keep momentum going if negotiations are moving quickly
• Don’t let aggressive CROs push you around
• Remain calm and exercise some patience
• Reach out to resources within the UCD research community for
advice
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Budget negotiations (con’t)…..
Payment Terms
REVIEW, REVIEW, REVIEW!!!
• Advance vs. start-up
• Interim Payments
• Payment Withholding
• Final Payment
• Screen Failures
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Resources
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Resources
•Clinical Trials Website
•UCD Clinical Research
Guidebook
•Process Maps
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Research Costs - UCDHS Query Tool
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B6 FIN to provide cost data for clinical trial billing codes
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CPT Codes - Quantim
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Questions ??
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