Evaluation of a Protocol Budget

Transcription

1 Evaluation of a Budget Margaret Matula, R.N., M.G.A. Director Research & Clinical Trials Anne Arundel Medical Center Annapolis, MD IPPCR 12/15/09 Slide # 1 Introduction Determine requirements: resources Establish protocol budget IPPCR 12/15/09 Slide # 2 Sample Phase 3, open label, randomized study comparing virologicirologic response to NNRTI-based vs. PI-based ART in treatment naïve women. IPPCR 12/15/09 Slide # A

2 Sample Trial 1 omen w/ prior SD NVP exposure for PMTCT N = 240 Trial 2 omen 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 IPPCR 12/15/09 Slide # B Requirements Eligibility Schedule Investigator s Brochure Lab Manual Contract Terms Personnel Equipment Toxicity Management Research vs. SOC IPPCR 12/15/09 Slide # 3 Duration Study intervention Follow-up IPPCR 12/15/09 Slide # 5

3 Subjects Enrollment Screening Eligibility Criteria # of Visits Population Base Size Minorities omen Children Other special groups IPPCR 12/15/09 Slide # 6 Subjects Recruitment and Retention Strategy / Plan women & minorities Advertising primary care providers mailings Incentives Tracking IRB Approval IPPCR 12/15/09 Slide # 9 Screening Clinical Evaluations Laboratory Evaluations Time Constraints Standard of Care Contract Budget IPPCR 12/15/09 Slide # 11

4 Clinical Study Visits Staff Expertise # and length Other Departments Exams Inpatient Special Procedures # and type IPPCR 12/15/09 Slide # 12 Location Single / Multi-site Urban / Rural Domestic / International University / Private / Public IPPCR 12/15/09 Slide # 14 Infrastructure Existing Space Clinical Laboratory Virology Office Other units Renovations / Alterations Consistent Immunology IPPCR 12/15/09 Slide # 15

5 Tests: # and type Specimens Processing Shipping Storage Location Serial studies Laboratory Preparation Serum / Tissue Shipping Dry Ice Transportation Storage Freezer Retrieval IPPCR 12/15/09 Slide # 16 Study Product Administration Management # Route Dispensing Accountability Storage Subject Education Counseling IPPCR 12/15/09 Slide # 18 Toxicity Treatment & Indemnification? Evaluation Billable? Additional Visits Follow-up needs? Additional Labs Reporting Reporting Budget item? Sponsor OHRP FDA Follow-up IPPCR 12/15/09 Slide # 20

6 Data CRFs Staff Development Completion Per Visit QC & QA # Forms Entry # Pages PI sign-off? Quality Equipment Submission PC Fax IPPCR 12/15/09 Slide # 21 Monitoring Clinical Adherence to protocol Adherence to regulatory & GCP Safety SAE reporting Data Source documentation Endpoints Time commitment IPPCR 12/15/09 Slide # 23 Location Training Number Staff Investigator Coordinator Meetings Travel Expenses Time Field Outreach Other sites IPPCR 12/15/09 Slide # 24

7 Personnel Experience Commitments Other research Faculty Attending Investigator Coordinator Research Nurses Laboratory Data Staff Statistician IPPCR 12/15/09 Slide # 26 Personnel continued Clinical: Physicians Mid-level providers Nurses Pharmacist Specialists / Consultants Social orker Monitor Quality Regulatory Administration: Fiscal Secretarial Other IPPCR 12/15/09 Slide # 28 Equipment and Supplies Clinical Laboratory Freezers Centrifuge Office Computers Furniture Mailing / Shipping Phone / Fax / Internet IPPCR 12/15/09 Slide # 30

8 Institution Institutional Review Board (IRB) Policies & Procedures Training Regulatory Federal NIH Policies Good Clinical Practice (GCP) IPPCR 12/15/09 Slide # 32 Subcontracts Other s Monitoring Pharmacy Laboratory Data Management Record Storage Equipment maintenance IPPCR 12/15/09 Slide # 33 Indirect Costs Requirements Facilities & Administration Overhead utilities cleaning maintenance % of direct costs personnel equipment IPPCR 12/15/09 Slide # 34

9 IPPCR 12/15/09 Slide # 36 Establishing a Budget Information for prices / costs Experience Industry standard? Include Start-up Screening & Follow-up Close-out out IPPCR 12/15/09 Slide # 37 Establishing a Budget continued Conserve costs while preserving safety and scientific integrity Necessary Negotiate rates Subcontract IPPCR 12/15/09 Slide # 38

10 Establishing a Budget continued Determine how costs will be charged Personnel hourly rate % time & benefits per study visit Labs real time / batched storage IPPCR 12/15/09 Slide # 39 Establishing a Budget continued Determine the REAL cost of conducting a protocol IPPCR 12/15/09 Slide # 40 Establishing a Budget continued Line item for each resource Cost per patient Spreadsheet Subtotal categories IPPCR 12/15/09 Slide # 41

11 Schedule HIV doc HX Con Med Sc 0 X X p 48 VF Step 2 DC Med X X X X X X X X X 12 X X PE X X X X X X X X X X 12 X X Hem X X X X X X X 12 X X Chem X X X X X X X 12 X X Lipid X X X 48 X X IPPCR 12/15/09 Slide # 42 Schedule Sc p 48 VF Step 2 DC LFTs X X X X X X X X X X 12 X X Preg HbSAg Lipase CPK Lactate X X X Repeat as indicated Perform if sx of pancreatitis Perform if sx of myositis Perform if sx of lactic acidosis CD4 / 8 X X X X X X 12 X X IPPCR 12/15/09 Slide # 43 Sc 0 Schedule p 48 VF Step 2 DC HIV RNA-rt X X X X X X 12 X X X HIV RNA-b X X Plasma resist X X X resist Store Plasma Plasma X X X X X X X X X 12 X X X Store PBMC PBMC X X X X X X X 24 PK X X Adher X X X X 24 QOL/RU X X X IPPCR 12/15/09 Slide # 44

12 Year 1 Personnel IPPCR 12/15/09 Slide # 45 Year 1 Routine Labs IPPCR 12/15/09 Slide # 46 Year 1 Ology Labs IPPCR 12/15/09 Slide # 47

13 Cost Coversheet IPPCR 12/15/09 Slide # 48 Summary Schedule Conserve Costs Preserve safety & science Necessary not interesting Determine Costs Develop Budget Accounting System: Expenses Invoicing Revenue IPPCR 12/15/09 Slide # 49 Contact Margaret Matula mmatula@aahs.org IPPCR 12/15/09 Slide # 50