David CloutierDirector, Research Center Management and

Development

Budgeting for Industry Sponsored Clinical Trials

Objectives

• Describe costs associated with clinical trial conduct

• Review a sample internal budget• Identify hidden costs • Identify the elements of sponsor budget• Describe post award activities related to

payment and budget changes

Budget Prioritization

Prioritize budget analysis and feasibility• Request 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

Interest and feasibility

Study the protocol carefullyIs the project feasible for your site

• Academic / Scientific interest• Resources• Research staff• Patient population

Identify Your CostsReview the Protocol Schematic and Informed Consent Document

Review the Protocol Schematic

• Hospital procedures (technical fees)• Physician practice costs (professional fees)• Lab costs• How many visits / Length of study• Visits until randomization• Coordinator time per visit / post visit

Compare to visits and procedures listed in the informed consent document

Build the Budget

• Per Patient Costs• Study Level Costs

Per Patient Costs

• Breakdown procedures by Coordinator, Physician, and Hospital Fees– ECG cost / Pro Fees / Coordinator filing– Lab tests / review / CRF filing– ECHO cost / Pro Fees / CRF filing– Medical History / CRF filing– Dispensing fees

• Assign costs for coordinator / staff time• Apply Indirect Cost rate

– 25% Industry Sponsored Trials

Coordinator Fees

• Regulatory document collection / filing

• Correspondence filing

• Case Report Form completion, submission

• Scheduling for pt visits, tests/scans

• Participant stipend processing

• Data query resolution

• Sponsor invoicing / accounts receivable

Study Level Costs

• Administrative Startup Fee• Pharmacy Set Up Fee• Document archiving, offsite storage• Advertising• Unscheduled visits• SAE reporting• Monitor visits• IRB Fees

– Initial Review, Amendments, Renewals

• Protocol Review• Site Initiation Visit• Contract and Budget Review• Investigator Meeting • Regulatory Documentation filing• Initial IRB Application preparation / submission• Informed Consent Document

– IRB Requested Revisions– Negotiating ICD w/ Sponsor

• Office Supplies

Startup Fee ($1500 - $5000)

Hidden Costs

• Extended start-up activities / timeline

• Pre-screening activities

• Increased hospital procedure costs

• Unscheduled visits

• Tracking study accounts receivable

• Query resolution

• Amendments

The Sponsor Budget

• Per Patient Amount comparable?

• Study Level costs covered?

• Indirect cost rate correct?

• Enrollment goals feasible?

• Screen failure reimbursement acceptable?

Negotiating

• Internal budget will differ from sponsor offer• Discourage sharing detailed internal budget with sponsor• Your internal costs may limit negotiation of future

projects• Sponsors retain database of previously negotiated

budgetsNegotiate reimbursement at the same level of detail as sponsor template– Per-visit reimbursements are acceptable– Line item expenses are acceptable

Sponsor Payment Terms

• What is the payment schedule?– Ad Hoc– Quarterly– After Monitor Visits and CRF auditing

• Are they relying on you to Invoice?– For all payments– Study Level Costs– Per Visit

Track your payments

• Budget statement• Payment memo• Invoice for your “Study Level Costs” and

reimbursable expenses• Sponsors miss payments• Request periodic payment reports from sponsors to

ensure that EFTs were received and directed to the correct fund-org

• Some sponsors rely on you to invoice for all the visits.

Initial Payment

Initial payment may include pre-payment Untangle start-up fees from initial payment by negotiating a

“non-refundable” start-up fee

Re-Negotiation is an Option

• Review protocol amendments for new work…– If the amendment changes work load or adds

procedures: re-negotiate– If sponsor allows more patients to be enrolled,

request more screen failures