1 / 31

SPCTRM Stanford/Packard Center for Translational Research in Medicine

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. SPCTRM website. SPCTRM calendar: http://med.stanford.edu/spctrm/education/index.html General Orientation

rusty
Download Presentation

SPCTRM Stanford/Packard Center for Translational Research in Medicine

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. SPCTRMStanford/Packard Center for Translational Research in Medicine Stanford University School of Medicine SARP Meeting 7/24/08 Study Budgeting Anna Hu, RN, MPH

  2. SPCTRM website • SPCTRM calendar: http://med.stanford.edu/spctrm/education/index.html • General Orientation • Budgeting and Billing Training • Workshops

  3. 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

  4. 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

  5. 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)

  6. Schedule of Events

  7. 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:

  8. 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

  9. 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

  10. CTRU-Clinical & Translational Research Unit (formerly known as GCRC)- • http://sccter.stanford.edu/programs/ctru.html • http://med.stanford.edu/gcrc/

  11. CTRU (cont’d) • Protocol Application Information & Fees - http://med.stanford.edu/gcrc/invest/apply.html • Stanford GCRC Laboratory - http://gcrclab.stanford.edu/

  12. Research Pharmacy-Investigational Drug Services (IDS) • Protocol • Investigational Brochure • Set up & Dispensing Fees

  13. 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

  14. 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

  15. 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

  16. Example of Weekly Report

  17. Weekly Report (cont’d)

  18. 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

  19. 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”).

  20. 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.

  21. 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

  22. 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

  23. 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

  24. Tx visit schedule (cont’d) • Other Evaluations: (optional) Pharmacogenomics/Interferon Response Assay ICF, Interferon Response Assay Sample, Pharmacogenomics Sample, Health Status Evaluation Questionnaire

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. Questions/Answers? SPCTRM clinicaltrials@med.stanford.edu X 8-7425 Anna Hu, RN, MPH anna.hu@stanford.edu X 8-7921

More Related