Budgeting for Industry Sponsored Clinical Trials

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Budgeting for Industry Sponsored Clinical Trials

• Shannon Parham
• Office of Research and
• The Clinical Research Program

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Objectives

• Identify your resources
• Describe associated costs
• Demonstrate how to write a internal budget
• Identify hidden costs
• Identify the elements of sponsors budget
• Describe post award activities related to payment
  and budget changes

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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
  sponsors budget

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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

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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

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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

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Build the Budget

• Per Patient Costs
• Study Level Costs

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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

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UMC Budget
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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

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Study Level Costs

• Screen Failures
• Study Initiation
• Electronic Data Capture Training
• Advertising / Recruitment
• IRB Fee
• Pharmacy Set Up Fee
• contd on next slide

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Study Level Costs (contd)

• Storage
• Unscheduled visits
• SAE reports
• Endpoints
• Monitor visits
• Additional IRB submissions

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UMC Budget
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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

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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 Investigators Guide to Clinical
Research Dr. David Ginsberg Centerwat
ch
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Review the sponsor budget.
Remember every company, every protocol, is
different.
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The Sponsors 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

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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

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Negotiating

• Perform a cost analysis and report this to the
  sponsor
• The internal budget procedure costs can differ
  from sponsor budget

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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

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Blank invoice O/R website
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Hidden Costs

• Delayed start / ICD process
• Pre-screening
• Increased hospital procedure costs
• Unscheduled visits
• Tracking study funds
• Query resolution
• Amendments

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Increased Hospital Procedure Costs? - renegotiate

• Increase cost of Stress Tests

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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

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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.

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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

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providing/receiving grant payments is the
single most inefficient activity in study
conduct. ACRP White Paper(survey of 1100
clinical research professionals)
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Office of Research5-5000Grants and
Contracts4-1040