Director Research & Clinical Trials - ippcr.nihtraining.com 12/15/09 Slide # Sample Protocol Trial 1...

IPPCR 12/15/09 Slide #

Evaluation of a Protocol BudgetEvaluation of a Protocol Budget

Margaret Matula, R.N., M.G.A. Margaret Matula, R.N., M.G.A. DirectorDirector

Research & Clinical TrialsResearch & Clinical Trials

Anne Arundel Medical CenterAnne Arundel Medical CenterAnnapolis, MDAnnapolis, MD

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•• Determine requirements: Determine requirements: ∗∗ ProtocolProtocol∗∗ Site resourcesSite resources

IntroductionIntroduction

•• Establish protocol budgetEstablish protocol budget

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Sample ProtocolSample Protocol

Phase 3, open label, randomized Phase 3, open label, randomized study comparing vstudy comparing virologic irologic

response to NNRTIresponse to NNRTI--based vs. based vs. PIPI--based ART in treatment based ART in treatment

nanaïïve women.ve women.

A


Sample ProtocolSample ProtocolTrial 1

Women w/ prior SD NVP exposure for PMTCT

N = 240

Trial 2

Women with no prior NVP exposure

N = 400

Randomize 1:1

Arm 1A• NVP QD x14D then BID• TDF QD• FTC QD

Arm 1B• LVP/RTV BID• TDF QD• FTC QD

B


ProtocolProtocol•• EligibilityEligibility•• ScheduleSchedule•• InvestigatorInvestigator’’s s

BrochureBrochure•• Lab ManualLab Manual•• Contract TermsContract Terms

RequirementsRequirements

SiteSite•• PersonnelPersonnel•• EquipmentEquipment•• Toxicity Toxicity

ManagementManagement•• Research vs. Research vs.

SOCSOC

3


DurationDuration

•• Study interventionStudy intervention•• FollowFollow--upup

5


SubjectsSubjects

ProtocolProtocol•• EnrollmentEnrollment•• ScreeningScreening•• Eligibility CriteriaEligibility Criteria•• # of Visits# of Visits

6

SiteSite•• Population BasePopulation Base

∗∗ SizeSize∗∗ MinoritiesMinorities∗∗ WomenWomen∗∗ ChildrenChildren∗∗ Other special Other special

groupsgroups


SubjectsSubjectsSiteSite•• Recruitment and RetentionRecruitment and Retention

∗∗ Strategy / PlanStrategy / Planwomen & minoritieswomen & minorities

∗∗ AdvertisingAdvertisingprimary care providersprimary care providersmailingsmailings

∗∗ IncentivesIncentives∗∗ TrackingTracking∗∗ IRB ApprovalIRB Approval

9


ScreeningScreeningProtocolProtocol•• Clinical EvaluationsClinical Evaluations•• Laboratory EvaluationsLaboratory Evaluations•• Time ConstraintsTime ConstraintsSiteSite•• Standard of CareStandard of Care•• ContractContract•• BudgetBudget

11


ClinicalClinical

ProtocolProtocol•• Study VisitsStudy Visits

∗∗ # and length# and length∗∗ ExamsExams

•• Special ProceduresSpecial Procedures∗∗ # and type# and type

12

SiteSite•• Staff ExpertiseStaff Expertise•• Other DepartmentsOther Departments•• InpatientInpatient


LocationLocation

•• Single / MultiSingle / Multi--sitesite•• Urban / RuralUrban / Rural•• Domestic / InternationalDomestic / International•• University / Private / PublicUniversity / Private / Public

14


InfrastructureInfrastructure

•• Existing SpaceExisting Space∗∗ ClinicalClinical∗∗ LaboratoryLaboratory∗∗ OfficeOffice∗∗ Other unitsOther units

•• Renovations / AlterationsRenovations / Alterations•• ConsistentConsistent

ImmunologyImmunologyVirologyVirology

15


LaboratoryLaboratoryProtocolProtocol•• Tests: # and typeTests: # and type•• SpecimensSpecimens

∗∗ ProcessingProcessing∗∗ ShippingShipping∗∗ Storage Storage

•• LocationLocation•• Serial studiesSerial studies

16

SiteSite•• PreparationPreparation

∗∗ Serum / TissueSerum / Tissue•• ShippingShipping

∗∗ Dry IceDry Ice∗∗ TransportationTransportation

•• StorageStorage∗∗ FreezerFreezer∗∗ RetrievalRetrieval


Study ProductStudy ProductProtocolProtocol•• AdministrationAdministration•• ##•• RouteRoute

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SiteSite•• ManagementManagement

∗∗ DispensingDispensing∗∗ AccountabilityAccountability

•• StorageStorage•• SubjectSubject

∗∗ EducationEducation∗∗ CounselingCounseling


ToxicityToxicityProtocolProtocol•• Treatment & Treatment &

EvaluationEvaluation∗∗ Additional VisitsAdditional Visits∗∗ Additional LabsAdditional Labs

•• ReportingReporting∗∗ SponsorSponsor∗∗ OHRPOHRP∗∗ FDAFDA•• FollowFollow--upup

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SiteSite•• Indemnification?Indemnification?•• Billable?Billable?•• FollowFollow--up needs?up needs?•• ReportingReporting•• Budget item?Budget item?


DataData

ProtocolProtocol•• CRFsCRFs

∗∗ DevelopmentDevelopment•• Per VisitPer Visit

∗∗ # Forms# Forms∗∗ # Pages# Pages

•• QualityQuality•• SubmissionSubmission

21

SiteSite•• StaffStaff

∗∗ CompletionCompletion∗∗ QC & QAQC & QA∗∗ EntryEntry∗∗ PI signPI sign--off?off?

•• EquipmentEquipment∗∗ PCPC∗∗ FaxFax


MonitoringMonitoring

•• ClinicalClinical∗∗ Adherence to protocolAdherence to protocol∗∗ Adherence to regulatory & GCPAdherence to regulatory & GCP

•• SafetySafety∗∗ SAE reportingSAE reporting

•• DataData∗∗ Source documentationSource documentation∗∗ EndpointsEndpoints

•• Time commitmentTime commitment23


MeetingsMeetings

ProtocolProtocol•• LocationLocation•• TrainingTraining•• NumberNumber•• StaffStaff

∗∗ InvestigatorInvestigator∗∗ CoordinatorCoordinator

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SiteSite•• Travel ExpensesTravel Expenses•• TimeTime•• FieldField

∗∗ OutreachOutreach∗∗ Other sitesOther sites


PersonnelPersonnel

•• ExperienceExperience•• CommitmentsCommitments

∗∗ Other researchOther research∗∗ FacultyFaculty∗∗ AttendingAttending

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•• InvestigatorInvestigator•• CoordinatorCoordinator•• Research NursesResearch Nurses•• LaboratoryLaboratory•• Data StaffData Staff•• StatisticianStatistician


Personnel continuedPersonnel continued……

•• Clinical: Clinical: ∗∗ PhysiciansPhysicians∗∗ MidMid--level level

providersproviders∗∗ NursesNurses∗∗ PharmacistPharmacist

•• Specialists / Specialists / ConsultantsConsultants

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•• Social WorkerSocial Worker•• MonitorMonitor•• QualityQuality•• RegulatoryRegulatory•• Administration:Administration:

∗∗ FiscalFiscal∗∗ SecretarialSecretarial

•• OtherOther


Equipment and SuppliesEquipment and Supplies

•• ClinicalClinical•• LaboratoryLaboratory

∗∗ FreezersFreezers∗∗ CentrifugeCentrifuge

•• OfficeOffice∗∗ ComputersComputers∗∗ FurnitureFurniture∗∗ Mailing / ShippingMailing / Shipping∗∗ Phone / Fax / InternetPhone / Fax / Internet

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InstitutionInstitution

•• Institutional Review Board (IRB)Institutional Review Board (IRB)•• Policies & ProceduresPolicies & Procedures•• TrainingTraining•• RegulatoryRegulatory

∗∗ FederalFederal∗∗ NIH PoliciesNIH Policies∗∗ Good Clinical Practice (GCP)Good Clinical Practice (GCP)

32


SubcontractsSubcontracts

•• Other SitesOther Sites•• MonitoringMonitoring•• PharmacyPharmacy•• LaboratoryLaboratory•• Data ManagementData Management•• Record StorageRecord Storage•• Equipment maintenanceEquipment maintenance

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•• Facilities & AdministrationFacilities & Administration∗∗ Overhead Overhead

utilitiesutilitiescleaningcleaningmaintenance maintenance

∗∗ % of direct costs % of direct costs personnelpersonnelequipmentequipment

Indirect Costs Indirect Costs —— Site RequirementsSite Requirements

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IPPCR 12/15/09 Slide #36


Establishing a Protocol BudgetEstablishing a Protocol Budget

•• Information for prices / costsInformation for prices / costs∗∗ ExperienceExperience∗∗ Industry standardIndustry standard∗∗ ??

•• IncludeInclude∗∗ StartStart--upup∗∗ Screening & FollowScreening & Follow--upup∗∗ CloseClose--outout

37


Establishing a Budget continuedEstablishing a Budget continued……

•• Conserve costs while preserving Conserve costs while preserving safety and scientific integritysafety and scientific integrity∗∗ NecessaryNecessary∗∗ Negotiate ratesNegotiate rates∗∗ SubcontractSubcontract

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•• Determine how costs will be chargedDetermine how costs will be charged∗∗ PersonnelPersonnel

hourly rate hourly rate % time & benefits% time & benefitsper study visitper study visit

∗∗ LabsLabsreal time / batchedreal time / batchedstoragestorage

39



Determine the REAL cost of Determine the REAL cost of conducting a protocolconducting a protocol

40



•• Line item for each resourceLine item for each resource•• Cost per patientCost per patient

∗∗ SpreadsheetSpreadsheet∗∗ Subtotal categoriesSubtotal categories

41


Protocol ScheduleProtocol Schedule

ScSc 00 2 2 WW

4 4 WW

8 8 WW

12 12 WW

16 16 WW

24 24 WW

36 36 WW

48 48 WW

p p 48 48 WW

VFVF Step Step 22 DCDC

HIV HIV docdoc XXHXHX XXCon Con MedMed XX XX XX XX XX XX XX XX XX 1212 XX XXPEPE XX XX XX XX XX XX XX XX XX XX 1212 XX XX

HemHem XX XX XX XX XX XX XX 1212 XX XXChemChem XX XX XX XX XX XX XX 1212 XX XXLipidLipid XX XX XX 4848 XX XX

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Protocol ScheduleProtocol Schedule

ScSc 00 2 2 WW 4 W4 W 8 8

WW12 12 WW

16 16 WW

24 24 WW

36 36 WW

48 48 WW

p p 48 48 WW


LFTsLFTs XX XX XX XX XX XX XX XX XX XX 1212 XX XXPregPreg XX XX

HbSAgHbSAg XXLipaseLipase

CPKCPK

LactateLactate

CD4 / 8CD4 / 8 XX XX XX XX XX XX 1212 XX XX

Repeat as indicated

Perform if sx of pancreatitis

Perform if sx of myositis

Perform if sx of lactic acidosis

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Protocol ScheduleProtocol ScheduleScSc 00 2 2

WW4 4 WW

8 8 WW

12 12 WW

16 16 WW

24 24 WW

36 36 WW

48 48 WW

p p 48 48 WW


HIV HIV RNARNA--rtrt XX XX XX XX XX XX 1212 XX XX XX

HIV HIV RNARNA--bb XX XXPlasma Plasma resistresist XX XX XXStore Store

PlasmaPlasma XX XX XX XX XX XX XX XX XX 1212 XX XX XXStore Store PBMCPBMC XX XX XX XX XX XX XX 2424 XX

PKPK XX XXAdherAdher XX XX XX XX 2424

QOL/RUQOL/RU XX XX 2424

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Year 1 Year 1 –– PersonnelPersonnel

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Year 1 Year 1 –– Routine LabsRoutine Labs

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Year 1 Year 1 –– ““OlogyOlogy”” LabsLabs

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Cost CoversheetCost Coversheet

48


SummarySummary

ProtocolProtocol•• Schedule Schedule •• Conserve CostsConserve Costs∗∗ Preserve safety & Preserve safety &

sciencescience∗∗ Necessary not Necessary not

interestinginteresting

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SiteSite•• Determine CostsDetermine Costs•• Develop BudgetDevelop Budget•• Accounting Accounting

System:System:∗∗ ExpensesExpenses∗∗ InvoicingInvoicing∗∗ RevenueRevenue


ContactContact

Margaret MatulaMargaret Matula

ee--mail: [email protected]: [email protected]

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