Clinical Trial Budgets K.J. Sprenger, RN BS, University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa, United States.

Budget Development The sponsor of the clinical trial will send a contract and budget for the trial. Think about the following: Can we recruit subjects? How many can we recruit realistically? Does the budget support the work to be done on the trial? What type of staff is needed? After reviewing the budget, protocol and the questions start modifying the budget to reflect your costs to conduct the trial.

Budget Development Find the study overview in the protocol. This is often a one page visit-by-visit outline of the study. Determine if the labs and testing procedures such as EKG’s, MRI scans, etc. will be analyzed at our local University of Iowa core lab or at the sponsor’s central site. Will there be other department charges: CRU, Nursing, Cell Lab

Budget Development Determine if there will be professional charges required for the technical tests performed. An example would be an ECG with interpretation by a Cardiologist. You want to negotiate a cost per subject to complete a clinical trial, not a cost per test or procedure. You may use a standard of care test result for clinical research if the protocol allows.

Budget Development Remember you may not bill insurance for a test, device, or service paid for by the Sponsor. If you anticipate your trial last multiple years, consider adding on a 7% inflation rate to each cost. All expenses are subject to F&A (Facilities and Administrative Costs) or Indirect Costs (Overhead) of 26% for industry sponsored studies.

Budget Development The following site has pricing and coding tools that can assist you in budget development: https://thepoint.healthcare.uiowa.edu/sites/Compliance/resear chbilling Excellent Presentation on why the JOC was developed: https://thepoint.healthcare.uiowa.edu/sites/Compliance/resear chbilling/Shared%20Documents/Res%20Billing_Sept%202014%20pr esentation.pptx

Sponsor Budget screening Day 0 Day 1 Day 2 Day 3 Day 7 Day 28 Day 90   screening Day 0 Day 1 Day 2 Day 3 Day 7 Day 28 Day 90 Day 365 Informed Consent $ 150 Inclusion/Exclusion $ 100 $ 100 Physical Exam SOC $ 150 includes height and weight at screening medical history Chemistry Hematology Respiratory Function $ 200 $ 200 only required if on ventilator. Includes rate, tidal volume, and airway pressures, PaO2 /FiO2 and PEEP Pregnancy test $ 30 ECG Vital Signs Investigational Product preparation and infusion $ 700 Blood sample for exploratory biomarkers $ 50 Hospitalization data EQ-5D $ 25 Adverse Events Concomitant Medications PI $ 300 $ 300 SC $ 250 $ 250 Total $ 1,330 $ 2,150 $ 750 $ 900 $ 925 $ 575 overhead 25% $ 333 $ 538 $ 188 $ 225 $ 231 $ 144 visit total $ 1,663 $ 2,688 $ 938 $ 1,125 $ 1,156 $ 719 total per subject $11,069

  screening Day 0 Day 1 Day 2 Day 3 Day 7 Day 28 Day 90 Day 365 Informed Consent $ 300 Inclusion/Exclusion $ 100 $ 100 Physical Exam SOC $ 150 medical history Chemistry Hematology Respiratory Function $ 200 $ 200 Pregnancy test $ 30 ECG Vital Signs Investigational Product preparation and infusion $ 1,500 Blood sample for exploratory biomarkers $ 87 Hospitalization data $ 50 EQ-5D Adverse Events Concomitant Medications Subject $ 55 PI $ 300 SC Total $ 1,530 $ 3,037 $ 787 $ 937 $ 1,005 $ 655 26% $ 398 $ 790 $ 205 $ 244 $ 261 $ 170 visit total $ 1,928 $ 3,827 $ 992 $ 1,181 $ 1,266 $ 825 total per subject $13,016

One Time Costs or Invoice Items Start up fees $ 17,010 WIRB fees upon invoice Initial Training-IP Prep + Docs- Per Processor $54.00 Aseptic Processing, Cell CT + Docs- Per Verifier $54.00 Refresher training - per processor and verifier $54.00 CRU room fee for outpatient visits $80.00 UI Human Subjects Office (HSO) Fee $1,500.00 CRU Review Fee $573.00 CRU Order Building $110.00/hr Training $110.00/hr Annual Regulatory and Financial Maintenance Fee--After 1st Year $2,000.00 UI Human Subjects Office (HSO) continuing review Fee $750.00 Binder fee $400.00 Monitoring Visits, Per Day $400.00/day Study Closeout $1,000.00 Long Term storage fee $500/yr Audit fee $1000.00/day

One Time Costs or Invoice Items Investigational Drug Pharmacy set-up fee Investigational Drug Pharmacy annual fee Advertising for Recruitment Fee (estimated based on study) Refer to Start Up Fee, Invoice and Financial Expectations sheet for additional items Be sure to add on the Indirect Cost of 26% on one time costs

I-CART Iowa Catalogue and Research Tracker I-CART is a web-based tool that allows researcher and teams to: Budget, Select and Order research services. All in one place! https://www.icts.uiowa.edu/

Sponsor Budget

Click: Submit to Start Services

How to find pricing list

Remember Include all costs The budget must total the estimated patient costs plus all one-time fees. All industry sponsored expenses are subject to F&A which is 26%

Questions? Contact me at kimberly-sprenger@uiowa.edu 319-353-8862 Always better to ask than to regret it!