Julie Calahan, CCRP

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CRC Basic 2.0Budgeting for Industry-Sponsored
Clinical Trials

• Julie Calahan, CCRP
• Clinical Trials Budget Analyst
• Health System Contracts Office

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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
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• 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)
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)
Assistance provided by Research Abstractor and
Budget Analyst

• Research Team determine feasibility
• Scientific Merit
• Financial Soundness
• Pt Accrual

Clinical Trial Contract Packet Forwarded to
Deans Office for Signature
Send packet to Chair for Approval Signature
No
Tabled
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 costsaccurate budget
• Accurate budgeting useful for feasibility,
  negotiations with sponsors, patient billing,
  invoicing

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• 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

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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?
Sponsor
Insurance/Medicare/Pt Acct needed to clinically
manage pt care
Insurance/Medicare/Pt Acct services pt receives
if not in CT but part of protocol SOC
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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
Invoicables
Per Patient
Tasks
Categories of 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
Protocol-related tasks Budget-related tasks IRB
Docs Training Pharmacy communication Communicatio
ns w/Sponsor
FEES
Advertisement Office supplies Pharmacy start-up,
inventory Translation of Informed Consent
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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
Adverse events x 8 Monitoring Visits
x2 Screen Failure x4 Annual Report
x1 IRB Docs x1 Admin/Correspondence
x1
Mods to Reg Documents Regulatory Binder,
Maintain IRB, Communicate Modifications, incl
1572 Contracts, Communicate Modifications
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 CostsIf you dont ask for it, you
wont get itStart-up fees should always be
non-refundable
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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
• Sponsors 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 neutralestablish 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 (cont)..
• 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
• Dont 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 (cont)..
• 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

B6 FIN to provide cost data for clinical trial
billing codes
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(No Transcript)
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CPT Codes - Quantim
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• Questions ??