Clinical Trial Budgets

Clinical Trial Budgets Catey Carter, BSN, RN, CCRC Office of Research The University of Texas Health Science Center at Houston Clinical Trial Budgets Clinical Research is “big business” Research trials are designed to answer a scientific question, however, they MUST make sense financially Research sites must be careful to determine if they can afford to do a study, Without Losing Money Objectives To identify and document all research items and services required for conducting clinical research trials. To document the financial responsibility for all items and services required by the research protocol To recover all costs involved in conducting clinical research trials Types of Funding Federal Grant: National Institute of Health, NHLBI, NCI Private Granting Agency: American Heart Association Industry Sponsored: Pharmaceutical/Device Co. Investigator Initiated: No funding, Private funding Federal and Private Research Grants Identify the costs of required procedures Estimate a % effort of the PI and investigator’s time that it takes to perform all of the tasks required for the study Multiple sites, consortium costs Appropriate costs Armed and Dangerous Industry contracts Protocol – Schedule of events Clinical Trial Agreement – Review and pay attention to budget section – Forward to Office of Sponsored Projects Sponsor’s reimbursement schedule – Review then set aside Regulatory checklist Questions to Consider What is the payment schedule – per patient? Include patient expenses? Include administrative time? Pharmacy costs adequate? Any shipping costs? Payment arrangements if a patient discontinues ? Study start up items IRB application fee IRB submission informed consent development pharmacy start up fee administrative fee (budget development/ negotiation) Clinical Research Unit processing fee Other costs Travel Advertising Records storage Equipment Dedicated fax line Computer and printer Supplies More Costs Per subject assessments/procedures: – – – – medical history inclusion criteria x rays, scans laboratory tests Refer to UTHSC-H Research Price list (base price) Contact specific department for diagnostic test pricing Other items – – – – – screen failures monitoring visit telephone calls parking for subjects stipend Hidden Costs Determine all “hidden costs” of clinical study Typically, > $2,000 in hidden costs per study are not being identified in budget at site and not being reimbursed by sponsors Many costs are underestimated Woodfin, Karen E. The CRC’s Guide to Coordinating Clinical Research. Boston, Mass: CenterWatch, 2004. Hidden or Under-estimated Costs IRB application submission (~ 8-12 hrs) Informed consent development (~ 4-5 hrs) Compiling regulatory documents IRB fees- indirect costs IRB continuing review fee – indirect costs Hidden or Under-estimated Costs Continuing review submission (~ 6 hrs) Protocol amendment submissions Length of consent process (~ 1-2 hrs) Protocol oversight – PI CRF Review – PI Adverse event review – PI Hidden or Under-estimated Costs SAE reporting to the sponsor and the IRB IND Adverse event reporting Lab processing and prep for shipping (~1 hr) Query resolution Monitor visits, Sponsor visits Phone calls to sponsor Hidden or Under-estimated Costs Phone calls to subject for scheduling/ follow up Unscheduled visit FDA audit , if occurs Miscellaneous supplies, dry ice Hidden or Under-estimated Costs Copying Screen Failures Consent translation fees Storage fees Travel Points to Remember Technical component (tests - MRI) Professional component (interpretation - report) UTP Memorial Hermann Hospital HCHD Other facilities Study staff’s time/effort – hourly or effort based Principal investigator’s time Study Nurse/coordinator’s time Technician Administrator’s time Enter CPT Code Here * CPT Code* 99214 99213 70482 99241 93000 93010 70450 71020 74000 93303 Modifier "26" if it applies MOD** Nonfederal UT Clinical Services Price List ** Determines BASELINE costs of UT services for nonfederal clinical trials DESCRIPTION OFFICE/OUTPT VISIT, EST EXPND DETAILED H&P MED DCSN MODERATE COMPLEXITY OFFICE/OUTPT VISIT, EST EXPND PROBLEM FOCUSED H&P MED DCSN LOW COMPLEXITY CONTRAST CAT SCANS OF SKULL OFFICE/OTPT CONSULT - LEVEL 1 ELECTROCARDIOGRAM, COMPLETE ELECTROCARDIOGRAM REPORT CAT SCAN OF HEAD OR BRAIN CHEST X-RAY TWO VIEWS FRONTAL AND LATERAL X-RAY EXAM OF ABDOMEN ECHO TRANSTHORACIC #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A 26 26 26 26 26 * ENTER CPT CODES in the 1st column and the description and cost will automatically display ** ENTER MODIFIER "26" in the 2nd column to get the cost of the professional fee for the servi Direct Costs Direct cost: any cost that can be easily identified with a specific project (grant/contract) – Salaries and Wages – Procedures and Tests – Materials & Supplies – Subcontracts – Consultants Indirect Costs Costs that cannot be directly related to a specific project Costs incurred in providing services in an operating environment within which the research project is carried out and on which it relies: Facilities maintenance, grounds, utilities, security, janitorial, maintaining/staffing libraries, ocm.od.nih.gov/dfas/faqIndirectCosts.asp#difference. Indirect Costs (IDC) Contracts- percentage of total direct costs - 30% – No exclusions Federal grants- percentage of modified direct costs - 48.5% Excludes: – Costs of routine care for research participants (X ray, ECG) – equipment greater than $5000/unit – CPHS review fee ocm.od.nih.gov/dfas/faqIndirectCosts.asp#difference. Look at the costs, then…. Decide how important is it to do this study – Previous history with sponsor – Establish history with sponsor – Importance of trial – Experience with investigational product – Subject population – Makes sense financially Fedor, Carol A. Responsible Research, A Guide for Coordinators. London, UK: Remedica, 2006. Financial Responsibility Who will pay for research services? – Identify financial responsibility for each service Are services standard of care (SOC) ? – If yes, bill to patient account/third party Financial Responsibility Are services required for research data only ? – Bill to research study, sponsor must pay: specified in contract (C) Committee for the Protection of Human Subjects policy: For services that are required for research only or research related injury, MAY NOT bill: – patient/third party – (Medicare/Medicaid -NCD rules do not apply at UTHSCH) Sponsor Negotiation: Industry Contracts Prepare sponsor budget template for negotiating with sponsor, if indicated – Justifies costs of study – Usually based on service per patient – Does not include salary information “Pass through” costs Sponsor Negotiation Sponsor considerations: May or may not be flexible – – – – Geographical location of site History with investigator Some sponsors have a 5% range Subject population – easy or difficult to recruit Ask for start up costs, nonrefundable: up front “Stick to your guns” Add indirect costs (30%) Amendments that expand scope of trial – Re-negotiate extra billable items Sponsor Negotiation Federal Grants – No negotiating – Must recover costs of billable items – Certain amount of money is allocated for research services – May ask for fewer enrolled subjects to reduce study costs – Must disclose any additional funding for project Private – May have negotiating room – May negotiate overhead (IDC) negotiation according to agency policy Final Budgets Include sponsor’s reimbursement schedule with the CTA (Clinical Trial Agreement- contract) Include the internal budget worksheet with institutional application (Review and Approval Form) Transmit to department and Dean’s Office for signatures and to the Office of Sponsored Projects UTHSC-H Clinical Trials Pre-Award Flowchart Federal/ Sponsor Initiated Protocols PI/ Research Staff Develops Budget - Consultation – Catey Carter, RN - Determination -Research vs. Standard of Care - List of Allowable Research Charges (Medicare) - UT Clinical Research Price List - Identify all Research costs** - Preparation of Research Budget Template - Sponsor Budget - Internal Budget -Sponsor Negotiation BUDGET **Include professional fees for hospital services as effort or billable to sponsor for research PI/Research staff OSP is provided: - Review and Approval Form, Dean’s office/ Dept. approval - Protocol - Clinical Study Agreement - Subcontract Requirements (if indicated) - List of Allowable Research Charges - Detailed Internal Budget - Administration Waiver Requests - Cost sharing Letter of Justification - Conflicts of Interest Certification - IRB Approval, Assurances - Affiliate Site Approval CPHS is provided: - Application - Protocol - Informed Consent - IRB Fee Billing Information - Conflicts of Interest Certification - Letters of Approval - Recruitment Material - HIPAA Form (if indicated) INSTITUTIONAL R&A Budget/ Agreement/ Assurances NOT Approved Budget/ Agreement/ Assurances Approved Research Approved Research NOT Approved Institutional Approvals Complete 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 NON-FEDERAL CLINICAL TRIAL BUDGET WORKSHEET Internal Study Budget Worksheet - for Research Costs Billable to Research Study Principal Investigator:________________________________________________________________ Study Title:________________________________________________________________________ A. ***STARTUP COSTS (non-refundable): Base Inv. Investigator Meeting IRB Fee: Awards >$50,000.00 = $1,500.00, <$50,000.00 = $1,000.00 *** Protocol submission Consent development Administrative Fee: Pharmacy Set Up & Storage: Other: SUB-TOTAL STARTUP COSTS $ B. OTHER COSTS: Travel Site Training Advertising Equipment Dry Ice Consent Translation fee UCRC Record Storage THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON Do not include standard of care costs billed to insurer/patient Sponsor:__________________________________________________________________________ Start Date:______________________________ End Date:_________________________________ TTL Inv. *** REMEMBER TO ADD %30 IDC FOR SEPARATE INVOICING - 30% IDC - 25 SUB-TOTAL OTHER COSTS DETERMINATION OF RESEARCH SERVICES 26 $ - Designate SOC or Contract in first column. Enter a cost for contracted items-each visit; enter SOC for each SOC item-each visit Standard of Care (SOC) vs. Contract (C) Screening Visit 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 C. PER PATIENT COSTS: EFFORT-BASED Time and COSTS Informed Consent Inclusion/Exclusion Criteria Chart Review Medical History Vitals & Blood Pressure Physical Examination Review Adverse Reactions Medication Dispensing/Returning Other EXPENSE-BASED COSTS Clinic Visit UCRC X rays & Scans ECG Other Tests/Procedures (itemize below) Out-patient Tests/Procedures (itemize below) Professional Fees (itemize below) Urine & Blood Workup Supplies Patient Stipend Patient Parking Other SUB-TOTAL PER PATIENT COSTS NUMBER OF PATIENTS SUB-TOTAL PATIENT COSTS Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Total Per PT Expense based costs 0 $ $ - - - - - - - - - - - - $ REQUIRED FOR INTERNAL BUDGET D. *PERSONNEL COSTS: Non-Federal Studies - Base Salary +Augmentation Salary F/B % Effort Principal Investigator Study Coordinator Nurse Technician Other $ Total - 65 SUB-TOTAL PERSONNEL COSTS* *Sub-Total Personnel Costs must reflect effort from section C Effort based R &A Internal budget $ $ $ $ $ $ $ - Sub-total Startup Costs Sub-total Other Costs Sub-total Patient Costs TOTALS Sub-total Personnel Costs Sub-total Indirect Costs @30% (Non-Federal) TOTAL STUDY COSTS** **Amount Should be Less than or Equal to Amount to be Received from Sponsor TO BE INCLUDED IN CONTRACT BUT NOT R&A (OVERSTATES PAFT BUDGET) E. ***OTHER INVOICE ITEMS: Base 30% IDC TTL Invoice Screening Failures (each) $ $ Monitoring Visit (each) $ $ Follow-up Unscheduled Visits $ $ Total Amount to Be FDA Audit Fee (every day, if occurs) $ $ Received From Sponsor IRB Fee - Continuing Review $300.00 $ $ Contract Residual Amendment/continuing review submission (each) $ $ Querie Resolution $ $ Telephone calls $ $ Total of Other Invoice Items $ $ $ *** REMEMBER TO ADD %30 IDC FOR SEPARATE INVOICING $ - Federal Internal Worksheet Federal Internal Budget Budget Worksheet 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 FEDERAL CLINICAL Re se a rch Budge t Workshe e t Sample Study Budget Worksheet - for Research Costs Billable to Research Study Principal Inv estigator:________________________________________________________________ Sponsor:_____________________________________________________________ Study Title:________________________________________________________________________ Start Date:______________________________ End Date:________________________ A. Study COSTS: Trav el Site Training Adv ertising Pharmacy Set up fee, storage Equipment Dry Ice Space rent Other SUB-TOTAL OTHER COSTS $ DETERMINATION OF RESEARCH SERVICES - Please designate SOC or Contract in first column. Enter a cost for contracted items-each visit; enter SOC for ea Sta nda rd Screening of Ca re Visit (SOC) vs. Contra ct( C) - B. PER PATIENT COSTS: 19 Subje ct to Indire ct Costs Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Total 20 21 22 23 24 25 26 27 28 29 30 Othe r Costs Consulting Physician Fees Supplies Patient Stipend Patient Parking Other SUB-TOTAL PER PATIENT COSTS NUMBER OF PATIENTS SUB-TOTAL PATIENT COSTS - - - - - - - - - - $ $ 31 C. Pa tie nt Ca re Costs: Sta nda rd Screening of Ca re Visit (SOC) vs. Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 Contra ct( For tre a tme nt of the pa tie nt, C) NOT Subje ct to Indire ct Costs Urine & Blood Workup - use of Local Lab ECG X rays & Scans Other Tests/Procedures (itemize below) Out-patient Tests/Procedures (itemize below) SUB-TOTAL PER PATIENT COSTS NUMBER OF PATIENTS SUB-TOTAL PER PATIENT COSTS Equipment >$5,000.00 per Unit Cost SUB-TOTAL NOT SUBJECT TO IDC - - - - - - - - - - $ $ $ - D. PERSONNEL COSTS: Required for Internal Budget Fe de ra l Studie s - Ba se Sa la ry Principal Inv estigator Co-Inv estigator Co-Inv estigator Study Coordinator Research Nurse Technician Sa la ry F/B % Effort Tota l $ $ $ $ $ $ $ $ Tota l UCRC Contribution - 53 Other 54 SUB-TOTAL PERSONNEL COSTS 55 56 Sub-total Other Costs 57 Sub-total Patient Costs 58 Sub-total Personnel Costs 59 Sub-total 60 Modified Total Indirect Costs @48.5% (Federal) 61 Costs Not Subject to IDC 62 TOTAL STUDY COSTS* 62 TOTALS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 SPONSOR BUDGET WORKSHEET - Costs Billable To RESEARCH Study Principal Investigator: Study Title: Sponsor: Start Date: End Date: A. ***STARTUP COSTS (non-refundable): Investigator Meeting IRB Fee: Awards >$50,000.00 = $1,500.00, <$50,000.00 = $1,000.00 Protocol submission Consent development Administrative Fee: Pharmacy Set Up & Storage: Other: SUB-TOTAL STARTUP COSTS B. OTHER COSTS: Travel Site Training Storage Advertising Equipment Dry Ice Consent Translation fee UCRC SUB-TOTAL STARTUP COSTS Standard of Care (SOC) or Contract Base 30% IDC - TTL Inv. - $ $ - 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 C. PER PATIENT COSTS: EFFORT-BASED COSTS Informed Consent Inclusion/Exclusion Criteria Chart Review Medical History Vitals & Blood Pressure Physical Examination Review Adverse Reactions Medication Dispensing/Returning UCRC EXPENSE-BASED COSTS Clinic Visit UCRC X rays & Scans ECG Other Tests/Procedures (itemize below) Out-patient Tests/Procedures (itemize below) Professional Fees (itemize below) Urine & Blood Workup Supplies Patient Stipend Patient Parking Other SUB-TOTAL PER PATIENT COSTS NUMBER OF PATIENTS SUB-TOTAL PATIENT COSTS TOTAL STUDY COSTS Sub-total Startup Costs Sub-total Other Costs Sub-total Patient Costs Indirect Costs @30% (Non-Federal) TOTAL STUDY COSTS Screening Visit Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Last Visit Total - - - - - - - - - - - - $ $ $ $ $ $ $ TO BE INCLUDED IN CONTRACT Base 30% IDC TTL Invoice - D. ***OTHER INVOICE ITEMS: UPON OCCURRENCE Screening Failures (each) Monitoring Visit (each) Follow-up Unscheduled Visits FDA Audit Fee (every day, if occurs) IRB Fee - Continuing Review $300.00 Amendment/continuing review submission (each) Query Resolution Telephone calls Total of Other Invoice Items $ - $ $ $ $ $ $ $ $ $ - $ $ $ $ $ $ $ $ $ - Total Amount to Be Received From Sponsor (does not include "Other invoice items") Other invoice items will be invoiced as they occur Things to Remember The CRC should be knowledgeable about grants, contracts and how to calculate a budget All costs of clinical trials must be identified and must have a determination as to be “paid for” (contract) by the sponsor, or standard of care (SOC) and to be billed to the patient account. TOTAL DIRECT COSTS are subject to indirect costs for non federal trials MODIFIED DIRECT COSTS are subject to indirect costs for all federal clinical research trials Communication between the research team is essential. FAQs Q. Who should prepare the budget? A. The PI should determine which clinical services are standard of care and which are required only for the research study. The research nurse/coordinator and/ or administrator prepares budget for PI approval. Q. Who is responsible for negotiating with the sponsor? A. The PI, research nurse, or administrator, however, please do not negotiate until all of the costs of the trial have been identified on the budget template. FAQs Q. What if the sponsor’s reimbursement doesn’t cover the costs of the trial? A. Re-look at the budget, check your costs. Reduce number of subjects? It may not make financial sense to do the trial at all. All costs must be covered. Q. Why does the budget grid have to be completed? A. The internal budget must show all of the study costs and financial responsibility, e.g., who is paying for the costs. References Fedor, Carol A. Responsible Research, A Guide for Coordinators. London, UK: Remedica, 2006. Woodfin, Karen E. The CRC’s Guide to Coordinating Clinical Research. Boston, Mass: CenterWatch, 2004. Office of Acquisition Management and Policy at the National Institutes of Health. DFAS-FAQ, Indirect costs. Available from ocm.od.nih.gov/dfas/faqIndirectCosts.asp#difference. Accessed June 13, 2006.