Transcript Stanford Packard Center For Translational Medicine SPCTRM

SPCTRM
Stanford/Packard Center for
Translational Research in Medicine
Stanford University
School of Medicine
SARP Meeting 7/24/08
Study Budgeting
Anna Hu, RN, MPH
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SPCTRM website
 SPCTRM calendar:
http://med.stanford.edu/spctrm/education
/index.html
 General Orientation
 Budgeting and Billing Training
 Workshops
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Case Study I-Federally sponsored, multisite, investigator initiated study conducted
on CTRU (GCRC)
 Study population: age > or = 18
 Study design: Phase IV, 12 week DB,




controlled trial
Will receive 1 injection weekly for 12 weeks
Evaluated monthly for safety and efficacy
Week 12 study therapy will be discontinued;
subjects will be unblinded & returned to their
MD for ongoing care
Week 16 safety f/u visit
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Study Treatment
 1 SQ injection of 40 mg OR 1 SQ
injection of placebo in a blinded and
alternating fashion for 12 weeks
 1 SQ of 50 mg in a blinded fashion every
week for 12 weeks
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Endpoints- Efficacy
 Change in DAS(CRP)28 score from
baseline to week 12
 Proportion of subjects achieving each
separately at week 12
-DAS(CRP)28 value < or = 3.2 (low
disease activity)
-DAS(CRP)28 value < 2.6 (remission)
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Schedule of Events
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Where to begin?
Review Protocol and Schedule of Events
Assess feasibility of protocol (staffing, resources,
can CTRU accommodate?)
SPCTRM website: http://med.stanford.edu/spctrm/
Clinical & Translational Research Planning
(CTRP) Workbooks:
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Demo of CTRP workbook
 Clinical & Translational Research
Planning (CTRP) Workbooks:
 Identify Research Tests/Procedures and
Service Codes
 Estimate Staff Effort (PI/Co-PI, CRC)
 Work w/ your assigned RPM on finalizing
budget
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 IRB
http://humansubjects.stanford.edu/research/medic
al/medical.html
 RMG/Budget Specialist: Who is your RPM?
“Sponsored” (Industry, NIH, Foundation)
Research Only:
http://med.stanford.edu/rmg/rpmmaster.html
 OSR/Contracts Officers by Dept:
http://ora.stanford.edu/supporting_files/osr_med_s
hortlist.xls
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CTRU-Clinical &
Translational Research Unit
(formerly known as GCRC) http://sccter.stanford.edu/programs/ctru.
html
 http://med.stanford.edu/gcrc/
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CTRU (cont’d)
 Protocol Application Information & Fees -
http://med.stanford.edu/gcrc/invest/apply
.html
 Stanford GCRC Laboratory -
http://gcrclab.stanford.edu/
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Research PharmacyInvestigational Drug Services
(IDS)
 Protocol
 Investigational Brochure
 Set up & Dispensing Fees
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Ancillary Services
SHC/LPCH Clinical Laboratory
 SHC/LPCH Clinical Labs Study Protocol
Form http://spctrm.stanford.edu/secure/study_f
orms/Study%20Protocol%20Form%2003
.20.07%20doc2.doc
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IRB approved/Budget finalized
 CTRP workbook (RPS & Routine Care
forms finalized)
 Complete Study Account Request Form
(98 account)
 Requires PTA# from dept finance person
 Email entire CTRP workbook to PFS
 PFS will email workbook back to you
password protected
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Begin enrolling study pts
 Complete Study Enrollment Form with
study pt info PRIOR to obtaining any
services from the hospital
 Indicates to PFS that your pt is a part of
your study
 If not completed in a timely manner-pt
insurance will be billed & weekly report
will not include your pt’s study charges
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Example of Weekly Report
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Weekly Report (cont’d)
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Case Study IIIndustry Sponsored
 Phase III
 Duration of study: 24 months
 Primary Objective: compare the efficacy
of 2 therapeutic regimens of “X” 800 mg
TID PO in combo w/ 1.5 “P” SC & weigh
based dosing of “R” PO to therapy in
previously untreated adult subjects w/
chronic Hepatitis C
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Case Study II (cont’d)
 Subjects > or = 18 years of age
 Subjects will be randomized in the three
treatment arms in a 1:1:1 ratio by IVRS
 All subjects will initiate therapy with 4
weeks of “P” + “R” treatment (“lead-in
period”).
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Case Study II (cont’d)
 After the 4 week lead-in period, “X” or
placebo will be added, based upon arm
to which the subject is randomized.
 At the end of treatment all subjects will
enter follow-up, whose length will vary
depending on the arm to which they
were randomized.
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Schedule of Events
 Screening Evaluations: IC, I/E criteria,
VS, Demo, MH, PE, AEs, Con Meds,
Liver Biopsy, Ultrasound, Chest X-ray
(PA/LAT), 12 Lead ECG, Ocular Exam
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Lab Evaluations
 Hematology, PT/PTT, AFP, ANA, Blood
Chemistry, TSH, Serum Pregnancy,
HCV-RNA PCR/HCV Genotype, Urine
Drug Screen
 CTRP workbook -drop-down list
 Lab Test Directory:
http://www.stanfordlab.com/LabTestGuid
e/search.aspx
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Treatment Visit Schedule
 Clinical Evaluations: I/E, VS, PE, AEs,
Con Meds, Call IVRS, Study Med
Dispensing & Drug Accountability,
Dosing Diary Review, Subject Telephone
Contact
 Lab Evaluations: Hematology, PT/PTT,
Blood Chemistry, TSH, Serum/Urine
Pregnancy, HCV-RNA PCR/HCV
Sequence Analysis, Urine Drug Screen
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Tx visit schedule (cont’d)
 Other Evaluations: (optional)
Pharmacogenomics/Interferon Response
Assay ICF, Interferon Response Assay
Sample, Pharmacogenomics Sample,
Health Status Evaluation Questionnaire
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Follow-up Visit Schedule
 Clinical Evaluations: VS, PE, AEs, Con
Meds
 Lab Evaluations: Hematology, PT/PTT,
Blood Chemistry, TSH, Serum
Pregnancy, HCV-RNA PCR/HCV
Sequence Analysis, Urine Drug Screen
 Other Evaluations: Health Status
Evaluation Questionnaire
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Next Steps:
 Complete CTRP workbook (RPS &
Routine Care Forms)
 Work w/ your CT RPM on finalizing
tests/procedures & service codes
 IRB/Budget/Contract Finalized; NOA
issued
 Obtain PTA# from dept finance person
 Complete Study Account Request Form
 Send workbook to PFS
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Next Steps (cont’d)
 Obtain 98 account from PFS
 Update workbook (Study Enrollment
Form) PRIOR to study pt acquiring any
study related tests/procedures from the
hospital
 Review Weekly Reports (hospital & pro
fees)
 Make any corrections and return to PFS
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Points to Consider
 CTRP workbook is a requirement to
begin budgeting process for ANY clinical
research involving patient care (incl.
obtaining research pricing
REGARDLESS of funding source)
 Completing the CTRP workbook (ALL
info on all tabs) is a requirement to
obtain a 98 and/or LPCH research
account
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Points to Consider (cont’d)
 Need to itemize all tests/procedures incl.
service/cpt codes on RPS form in order
to charge to a research account
 Need to obtain PTA# from dept finance
person in order to initiate 98 account
 Need to complete Study Enrollment
Form or else your patient/insurance will
be billed
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Points to Consider (cont’d)
 Completing the study enrollment form
ensures your research pt charges will
show up on weekly billing reports
 2 separate weekly reports 1) hospital
and 2) pro fees only
 Other Study Forms may apply-check
SPCTRM website under Study Forms
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Questions/Answers?
SPCTRM
[email protected]
X 8-7425
Anna Hu, RN, MPH
[email protected]
X 8-7921
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