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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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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:

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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Example of Weekly Report

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Weekly Report (cont’d)

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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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Questions/Answers?

SPCTRM

clinicaltrials@med.stanford.edu

X 8-7425

Anna Hu, RN, MPH

anna.hu@stanford.edu

X 8-7921