Post on 29-Dec-2015
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SPCTRMStanford/Packard Center for Translational Research in Medicine
SARP Meeting 7/24/08
Study Budgeting
Anna Hu, RN, MPH
Stanford University School of Medicine
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, multi-site, 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
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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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:
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/medical/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_shortlist.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/
Research Pharmacy-Investigational 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_forms/Study%20Protocol%20Form%2003.20.07%20doc2.doc
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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Case Study II-Industry 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/LabTestGuide/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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