Clinical Trials Budgeting

Objectives Demystify clinical trials budgeting Increase preparer’s understanding and comfort level with financial aspect of clinical trials Provide tools to develop a consistent approach to budgeting

Industry Sponsored v. Grants Subject to different sets of regulations Industry sponsored projects are not capped; they do not begin with a pool of funds that are drawn down More freedom to negotiate; not typically a “take it or leave it” At minimum, need to cover costs, but it’s ok to do a little better than cover costs

Overview We are going to look at budgeting by looking at two types of studies: Study with Patient Charges Registry/Observational Study Examples of actual protocols will be used to illustrate various issues that arise in budgeting.

Ex. 1: Study with Patient Charges 1. Start with reviewing Final Protocol *Look at Schedule of Visits; Schedule of Procedures 2. Break down each procedure into component parts 3. Identify all costs CMH will incur 4. Add in personnel time 5. Compare to sponsor’s offer

How do I determine what CMH’s costs are? Assessments – ask: who and how long? Labs – Is CMH only collecting and preparing samples to send out? Or running test here? If using our lab, request pricing from lab Patient Charges Get CPT codes (from protocol, sponsor, PI or administrator) Ask Kris or CRU (if planning on using CRU) Will you need report/interp. or is there central reader? PI & CRA fees – need to calculate number of hours to be spent on study and multiply by hourly rate plus 26% fringe. OSP can help with salary info.

The EGD/biopsy ….. EGD/biopsy indicated as SOC, but study requires it within a specific window (within 6 weeks of BLV). So, we still need to determine a price in case patient has no insurance or it will not be considered SOC, etc.

As it turned out… Endoscopy Costs included: Pharmacy $245 Operating Room $1171 Anesthesia $585 Recovery Room $1272 Medical Supplies $186 Physician Pro Fee $1596 Anesthesia Pro Fee $927

For a grand total of… $5,982.00!* It can be very costly to miss charges! *This study began before EPIC research pricing established.

How will I know all the charges a procedure requires? Ask PI or Dept. Administrator what charges are typically included in procedure Refer to studies conducted in the past Find patient(s) that has had procedure recently and check what codes were billed Ask yourself or PI/Administrator if sedation generally required, ancillary labs or pathology Most important thing is to get in the habit of asking the questions, because there are resources available to help!

Personnel Calculate number of hours each key person will spend per patient or per visit Also total number of hours spent preparing for and conducting study: Investigator meeting/Teleconferences/Travel/Training Department Meetings Subject Population Prescreen (do we have pts that qualify) IRB prep & submission (protocol review, letters of support) Phone calls re study/ Feasibility surveys Initiation Visit and Subsequent Monitoring Visits Subject visits, Data Entry

Compare to Sponsor Budget Compare your notes from review of protocol along with CMH costs to the compensation offered by the sponsor

Registries or Retrospective Studies These studies appear easier to budget because the costs are “soft”, i.e. primarily personnel It can be tempting to simply accept the sponsor’s budget, but go through the same process as clinical trials

Things to Consider… If questionnaire is involved, how long is the questionnaire? Is it easy to read and follow? Is it manual or electronic? Will you be required to de-identify medical records? Are they in EPIC or on paper? Adverse Events Monitoring and Reporting (of medical adverse events) Storage Related Costs: Record retrieval, copy, travel, etc

Tools Clinical Trial Budget Template CMH Cost v. Sponsor Offer Worksheet

Checklist Start with Final protocol Copy of/access to CRF, questionnaires, etc. Monitoring – How often? By CRO or sponsor? Subject Population – will advertising be necessary? Will it be easy or difficult to enroll subjects? Identify CMH fixed costs: labs, procedures, room fees, pro fees, CRU, pharmacy, supplies, etc How much PI/CRA/nurse/admin time required Preparation – Investigator meetings, department meetings, phone calls, feasibility, IRB

Questions? Kristine Martens, JD Assistant Director Office of Sponsored Programs Ann & Robert H. Lurie Childrens’ Hospital of Chicago 225 E. Chicago Ave., Box 205 Chicago, IL 60611 773.755.6561 KIMartens@luriechildrens.org