View
220
Download
3
Category
Preview:
Citation preview
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
1
IPPCR 12/15/09 Slide #
•• Determine requirements: Determine requirements: ∗∗ ProtocolProtocol∗∗ Site resourcesSite resources
IntroductionIntroduction
•• Establish protocol budgetEstablish protocol budget
2
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
DurationDuration
•• Study interventionStudy intervention•• FollowFollow--upup
5
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
SubjectsSubjectsSiteSite•• Recruitment and RetentionRecruitment and Retention
∗∗ Strategy / PlanStrategy / Planwomen & minoritieswomen & minorities
∗∗ AdvertisingAdvertisingprimary care providersprimary care providersmailingsmailings
∗∗ IncentivesIncentives∗∗ TrackingTracking∗∗ IRB ApprovalIRB Approval
9
IPPCR 12/15/09 Slide #
ScreeningScreeningProtocolProtocol•• Clinical EvaluationsClinical Evaluations•• Laboratory EvaluationsLaboratory Evaluations•• Time ConstraintsTime ConstraintsSiteSite•• Standard of CareStandard of Care•• ContractContract•• BudgetBudget
11
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
LocationLocation
•• Single / MultiSingle / Multi--sitesite•• Urban / RuralUrban / Rural•• Domestic / InternationalDomestic / International•• University / Private / PublicUniversity / Private / Public
14
IPPCR 12/15/09 Slide #
InfrastructureInfrastructure
•• Existing SpaceExisting Space∗∗ ClinicalClinical∗∗ LaboratoryLaboratory∗∗ OfficeOffice∗∗ Other unitsOther units
•• Renovations / AlterationsRenovations / Alterations•• ConsistentConsistent
ImmunologyImmunologyVirologyVirology
15
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
Study ProductStudy ProductProtocolProtocol•• AdministrationAdministration•• ##•• RouteRoute
18
SiteSite•• ManagementManagement
∗∗ DispensingDispensing∗∗ AccountabilityAccountability
•• StorageStorage•• SubjectSubject
∗∗ EducationEducation∗∗ CounselingCounseling
IPPCR 12/15/09 Slide #
ToxicityToxicityProtocolProtocol•• Treatment & Treatment &
EvaluationEvaluation∗∗ Additional VisitsAdditional Visits∗∗ Additional LabsAdditional Labs
•• ReportingReporting∗∗ SponsorSponsor∗∗ OHRPOHRP∗∗ FDAFDA•• FollowFollow--upup
20
SiteSite•• Indemnification?Indemnification?•• Billable?Billable?•• FollowFollow--up needs?up needs?•• ReportingReporting•• Budget item?Budget item?
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
MeetingsMeetings
ProtocolProtocol•• LocationLocation•• TrainingTraining•• NumberNumber•• StaffStaff
∗∗ InvestigatorInvestigator∗∗ CoordinatorCoordinator
24
SiteSite•• Travel ExpensesTravel Expenses•• TimeTime•• FieldField
∗∗ OutreachOutreach∗∗ Other sitesOther sites
IPPCR 12/15/09 Slide #
PersonnelPersonnel
•• ExperienceExperience•• CommitmentsCommitments
∗∗ Other researchOther research∗∗ FacultyFaculty∗∗ AttendingAttending
26
•• InvestigatorInvestigator•• CoordinatorCoordinator•• Research NursesResearch Nurses•• LaboratoryLaboratory•• Data StaffData Staff•• StatisticianStatistician
IPPCR 12/15/09 Slide #
Personnel continuedPersonnel continued……
•• Clinical: Clinical: ∗∗ PhysiciansPhysicians∗∗ MidMid--level level
providersproviders∗∗ NursesNurses∗∗ PharmacistPharmacist
•• Specialists / Specialists / ConsultantsConsultants
28
•• Social WorkerSocial Worker•• MonitorMonitor•• QualityQuality•• RegulatoryRegulatory•• Administration:Administration:
∗∗ FiscalFiscal∗∗ SecretarialSecretarial
•• OtherOther
IPPCR 12/15/09 Slide #
Equipment and SuppliesEquipment and Supplies
•• ClinicalClinical•• LaboratoryLaboratory
∗∗ FreezersFreezers∗∗ CentrifugeCentrifuge
•• OfficeOffice∗∗ ComputersComputers∗∗ FurnitureFurniture∗∗ Mailing / ShippingMailing / Shipping∗∗ Phone / Fax / InternetPhone / Fax / Internet
30
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
SubcontractsSubcontracts
•• Other SitesOther Sites•• MonitoringMonitoring•• PharmacyPharmacy•• LaboratoryLaboratory•• Data ManagementData Management•• Record StorageRecord Storage•• Equipment maintenanceEquipment maintenance
33
IPPCR 12/15/09 Slide #
•• Facilities & AdministrationFacilities & Administration∗∗ Overhead Overhead
utilitiesutilitiescleaningcleaningmaintenance maintenance
∗∗ % of direct costs % of direct costs personnelpersonnelequipmentequipment
Indirect Costs Indirect Costs —— Site RequirementsSite Requirements
34
IPPCR 12/15/09 Slide #
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
IPPCR 12/15/09 Slide #
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
38
IPPCR 12/15/09 Slide #
Establishing a Budget continuedEstablishing a Budget continued……
•• 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
IPPCR 12/15/09 Slide #
Establishing a Budget continuedEstablishing a Budget continued……
Determine the REAL cost of Determine the REAL cost of conducting a protocolconducting a protocol
40
IPPCR 12/15/09 Slide #
Establishing a Budget continuedEstablishing a Budget continued……
•• Line item for each resourceLine item for each resource•• Cost per patientCost per patient
∗∗ SpreadsheetSpreadsheet∗∗ Subtotal categoriesSubtotal categories
41
IPPCR 12/15/09 Slide #
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
42
IPPCR 12/15/09 Slide #
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
VFVF Step Step 22 DCDC
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
43
IPPCR 12/15/09 Slide #
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
VFVF Step Step 22 DCDC
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
44
IPPCR 12/15/09 Slide #
SummarySummary
ProtocolProtocol•• Schedule Schedule •• Conserve CostsConserve Costs∗∗ Preserve safety & Preserve safety &
sciencescience∗∗ Necessary not Necessary not
interestinginteresting
49
SiteSite•• Determine CostsDetermine Costs•• Develop BudgetDevelop Budget•• Accounting Accounting
System:System:∗∗ ExpensesExpenses∗∗ InvoicingInvoicing∗∗ RevenueRevenue
Recommended