Budgeting for Clinical TrialsBudgeting for Clinical Trials

Carolyn Strickland, RN, BSN, CCRCCarolyn Strickland, RN, BSN, CCRCResearch Billing Services ConsultantResearch Billing Services Consultant

Office of Contracts ManagementOffice of Contracts Management

ObjectivesObjectives

Review basics of a clinical trial Review basics of a clinical trial budgetbudget

Review “PriceChecker” on Review “PriceChecker” on StarbriteStarbrite

Provide tips on the most common Provide tips on the most common mistakes we see in OCMmistakes we see in OCM

Most Common Budget Mistakes With Budgets for Most Common Budget Mistakes With Budgets for Industry-Initiated ProjectsIndustry-Initiated Projects

1)1) Missing IDS fees Missing IDS fees

2)2) Missing IRB feesMissing IRB fees

3)3) Lack of knowledge re use of CRC space & feesLack of knowledge re use of CRC space & fees

4)4) Accounting for full staff effortAccounting for full staff effort

5)5) VUMC indirect costsVUMC indirect costs

6)6) Start-up FeeStart-up Fee

7)7) Reimbursement for protocol proceduresReimbursement for protocol procedures

8)8) Annual cost increase for budget itemsAnnual cost increase for budget items

9)9) Archive feesArchive fees

Purpose of a BudgetPurpose of a Budget

Understand the costUnderstand the cost

Identify who will pay for whatIdentify who will pay for what

Documentation of costDocumentation of cost

Informed decisionInformed decision

Getting StartedGetting Started

Carefully review protocolCarefully review protocol

Input from investigator, coordinator, Input from investigator, coordinator, sponsor sponsor

Know institutional requirements- Know institutional requirements- finance, compliance finance, compliance

Price quotesPrice quotes

Developing BudgetDeveloping Budget

List study events and staff timeList study events and staff time

Identify hidden costsIdentify hidden costs

Account for institutional indirect Account for institutional indirect

-industry sponsored 29%-industry sponsored 29%

Identify standard of care (Routine Identify standard of care (Routine Care) and research costsCare) and research costs

Routine CareRoutine Care

Principle investigator and coordinator must Principle investigator and coordinator must carefully identify usual and customary care carefully identify usual and customary care procedures vs. research specific procedures vs. research specific proceduresproceduresUsual and customary care procedures Usual and customary care procedures would probably be performed if the patient would probably be performed if the patient were not on the studywere not on the studyRoutine care tests and results may be Routine care tests and results may be used for researchused for research

Research CostsResearch Costs

Research specific procedures would Research specific procedures would probably not be performed if the probably not be performed if the patient were not on a studypatient were not on a study

Can not bill insurance for any item Can not bill insurance for any item that is reimbursed by sponsorthat is reimbursed by sponsor

Schedule of Events exampleSchedule of Events example

STUDY VISIT FLOW CHART

*ET=Early Termination

Start-up CostsStart-up Costs

Protocol reviewProtocol reviewStaff trainingStaff trainingBudget preparationBudget preparationSite selection/initiation visitSite selection/initiation visitInvestigator meetingsInvestigator meetingsDevelopment of study toolsDevelopment of study toolsAdministration (budget)Administration (budget)RegulatoryRegulatory

Start-up CostsStart-up Costs

NonrefundableNonrefundable

Up front Up front

Average start-up fee $10,000Average start-up fee $10,000

Fixed CostsFixed Costs

IRB fees- Institutional charge for IRB IRB fees- Institutional charge for IRB review, amendments, annual reviewreview, amendments, annual review

Archive feesArchive fees

Pharmacy review; set-up fee, annual fee, Pharmacy review; set-up fee, annual fee, close-out feeclose-out fee

External audit feeExternal audit fee

Radiology set-up feeRadiology set-up fee

Lab set-upLab set-up

Close out activitiesClose out activities

Personnel costsPersonnel costsScreeningScreeningOutreachOutreachConference calls and emailConference calls and emailPatient visitsPatient visitsStudy documentationStudy documentationRegulatoryRegulatoryData managementData managementSAEsSAEsMonitoring visitsMonitoring visitsShippingShippingMeetingsMeetings

Study Subject CostsStudy Subject Costs

Assessments- medical history, physical exam, Assessments- medical history, physical exam, adverse eventsadverse eventsMedical procedures- radiology, cardiologyMedical procedures- radiology, cardiologyProfessional feesProfessional feesOffice visits/facility feesOffice visits/facility feesLab workLab workMedical and/or lab suppliesMedical and/or lab suppliesHospital bed Hospital bed VICTR/Clinical Research CenterVICTR/Clinical Research CenterScreen FailuresScreen Failures

Administrative CostsAdministrative Costs

Office suppliesOffice supplies

Telephone or fax chargesTelephone or fax charges

Pager Pager

VoicemailVoicemail

ComputerComputer

Postage/ShippingPostage/Shipping

Payment termsPayment terms

CriticalCritical

Negotiated by the departmentNegotiated by the department

Advance paymentAdvance payment

Payment triggerPayment trigger

Payment schedulePayment schedule

One time expensesOne time expenses

Payment termsPayment terms

Prorated paymentProrated paymentAnnual cost adjustmentAnnual cost adjustmentPayment adjustmentsPayment adjustmentsHoldbackHoldback

-Per institution policy holdback -Per institution policy holdback can can not exceed 20%not exceed 20%

Sponsor BudgetSponsor BudgetDay: 2 3 8 15 22 29 36 Termination 30-day F/U Subsequent Cycles

Screening/ Start of RX

Procedures Baseline Day 1

Study History / Medication History / Informed Consent 95.00 95.00Vital Signs, Body Weight, Adverse Event and Concomitant Medication Assessment

$75.00 $75.00 $75.00 $75.00 $75.00 $75.00 $75.00 $75.00 $75.00675.00 75.00

0.00 150.00

Hematology, Chemistry, 100.00 165.00 165.00 100.00 165.00 100.00 165.00 100.00 100.00 1,160.00 100.00Special Labs:Tropinin, BNP 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 400.00 50.00

PK Blood 75.00 150.00 75.00 75.00 75.00 75.00 75.00 75.00 675.00 75.00

Urinalysis 12.00 12.00 12.00 12.00 12.00 12.00 12.00 40.00 124.00 12.00

Venipuncture 15.75 15.75 15.75 15.75 15.75 15.75 15.75 15.75 126.00 15.75

Serum Pregnancy Test 75.00 75.00 75.00 225.00ECG 360.00 360.00 360.00 360.00 360.00 360.00 360.00 360.00 2,880.00ECHO / MUGA 600.00 600.00

Pharmacy dispensing 25.00 25.00 25.00 25.00 100.00 25.00

Tumor Marker 50.00 50.00 25.00

In Patient/Out Patient Charges 2,040.00 525.00 2,565.00

Sub -Total Procedures 1,130.00 2,467.75 827.75 392.75 535.00 777.75 1,237.75 4,644.00 737.75 790.75 75.00 9,675.00 527.75

Administrative Costs

Study Coordinator/Data Mgmt. 1,000.00 1,000.00 75.00 75.00 75.00 75.00 500.00 75.00 75.00 50.00 50.00 3,050.00 600.00

Principal Investigator Fee 1,000.00 1,000.00 750.00

Professional Charge 0.00

Administrative Fee 500.00 500.00 250.00

Sub -Total Administrative 2,500.00 1,000.00 75.00 75.00 75.00 75.00 500.00 75.00 75.00 50.00 50.00 4,550.00 1,600.00

Sub-Total Overall 3,630.00 3,467.75 902.75 467.75 610.00 852.75 1,737.75 4,719.00 812.75 840.75 125.00 14,225.00 2,127.75

Overhead (29%) 1,052.70 1,005.65 261.80 135.65 122.00 247.30 503.95 1,368.51 235.70 243.82 36.25 4,125.25 553.22

Total Per Patient 4,682.70 4,473.40 1,164.55 603.40 732.00 1,100.05 2,241.70 6,087.51 1,048.45 1,084.57 161.25 18,350.25 2,680.97

IRB/REB FeeStudy Activation Fee Payments will be based on receipt of completed CRFsInformations Admin. Fee Payments will be based on visit (not procedure)Pharmacy Admin. Fee Payments will be made quarterlyLaboratory Admin. Fee Sponsor will pay nonrefundable study start up costs and upfront payment of one subject ($ 18,350.25) upon signature of the contractSub-TotalOverhead = 29% Sponsor will withhold 20% of the total patient costs until end of study (following resolution of all queries)Total Start-Up 10,000.00$

IRB Amendment Fee $500.00IRB Continuing Review Fee $750.00

Totals

Sponsor will reimburse the following procedures on a fee for service basis.

Sponsor will reimburse site for a maximum of 2 patients who screened but did not enroll in the study. Both patients must have a signed informed consent form.

Sponsor BudgetSponsor BudgetExhibit B – Clinical Study Financial TermsExhibit B – Clinical Study Financial Terms$5000$5000 Investigator FeeInvestigator Fee$3750$3750 IRB FeeIRB Fee$5000$5000 Lab FeeLab Fee$700$700 Per patient Fee (estimate 150 patients) estimate $1,050,000Per patient Fee (estimate 150 patients) estimate $1,050,000$118,750$118,750 Estimated Total (based on 150 patients)Estimated Total (based on 150 patients)$17,812.50$17,812.50 15 % payable upon IRB Approval (Institution will invoice Sponsor)15 % payable upon IRB Approval (Institution will invoice Sponsor)$12,963.75$12,963.75 Per month for six months after first patient enrolled. Total $77,782.50 Per month for six months after first patient enrolled. Total $77,782.50$23,155.00$23,155.00 At close out based on 150 patientsAt close out based on 150 patientsInstitution will invoice Sponsor in writing Institution will invoice Sponsor in writing Any patients over 150 forecasted billed at $700 /per patientAny patients over 150 forecasted billed at $700 /per patientAny patients under 150 deducted at $700/per patientAny patients under 150 deducted at $700/per patientIRB amendments and continuing reviews will be an invoiceable pass-through cost at $500 each IRB amendments and continuing reviews will be an invoiceable pass-through cost at $500 each

amendment, $750 each continuing review.amendment, $750 each continuing review.All payments made pursuant to this Agreement shall be made payable to Vanderbilt University All payments made pursuant to this Agreement shall be made payable to Vanderbilt University

Medical Center and directed to the following address:Medical Center and directed to the following address:Attn: Stephen ToddAttn: Stephen ToddAssociate DirectorAssociate DirectorDepartment of FinanceDepartment of FinanceAcademic and Research EnterpriseAcademic and Research EnterpriseVanderbilt University Medical CenterVanderbilt University Medical CenterDept AT 40303Dept AT 40303Atlanta, GA 31192-0303Atlanta, GA 31192-0303Each payment voucher should reflect IMI’s name, Protocol Number, and the Principal Investigator’s Each payment voucher should reflect IMI’s name, Protocol Number, and the Principal Investigator’s

name. Institution’s Federal Tax Identification Number is____62-0476822_______. name. Institution’s Federal Tax Identification Number is____62-0476822_______.

NegotiationNegotiation

Budget process requires negotiationBudget process requires negotiation

DocumentationDocumentation

ConfidenceConfidence

Ideal vs. bottom lineIdeal vs. bottom line

Compromise Compromise

Mutual agreementMutual agreement

Example of Price Checker Screen – Basic Instructions

Example of Price Checker Screen – Discounts/RatesExample of Price Checker Screen – Discounts/Rates

Example of Price Checker ScreenExample of Price Checker Screen

Most Common Budget Mistakes With Most Common Budget Mistakes With Budgets for Industry-Initiated ProjectsBudgets for Industry-Initiated Projects

1)1) Missing IDS fees – 4 fees including: Initial submission - Missing IDS fees – 4 fees including: Initial submission - ~$2000-$3000; Annual fee - ~$1650 (varies); Close-out - ~$2000-$3000; Annual fee - ~$1650 (varies); Close-out - ~$650; Dispensation of drug – varies. Always get an ~$650; Dispensation of drug – varies. Always get an IDS quote.IDS quote.

2)2) Missing IRB fees – 3 fees including: Initial submission - Missing IRB fees – 3 fees including: Initial submission - $2250; Amendments each $500; Continuing Review - $2250; Amendments each $500; Continuing Review - $750.$750.

3)3) Lack of knowledge re use of CRC space & feesLack of knowledge re use of CRC space & fees

4)4) Accounting for full staff effortAccounting for full staff effort

5)5) A misunderstanding or lack of knowledge re VUMC A misunderstanding or lack of knowledge re VUMC indirect costsindirect costs

(continued next slide)(continued next slide)

Most Common Budget Mistakes With Budgets Most Common Budget Mistakes With Budgets for Industry-Initiated Projects (continued)for Industry-Initiated Projects (continued)

6)6) Failure to obtain Start-up FeeFailure to obtain Start-up Fee

7)7) Inadequate or no reimbursement for protocol Inadequate or no reimbursement for protocol procedures; use tools such as Price-Checker; i.e. procedures; use tools such as Price-Checker; i.e. pathology fees for tissue samplespathology fees for tissue samples

8)8) Failure to build in annual cost increase for budget itemsFailure to build in annual cost increase for budget items

9)9) Archive feesArchive fees

QuestionsQuestions??

Contact for Budget Contact for Budget AssistanceAssistance

Carolyn Strickland, RN, BSNCarolyn Strickland, RN, BSNResearch Billing Services ConsultantResearch Billing Services Consultant

Office of Contracts ManagementOffice of Contracts Management936-6691936-6691

carolyn.strickland@vanderbilt.educarolyn.strickland@vanderbilt.edu