Clinical Trials Budgeting Objectives Demystify clinical trials budgeting

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: 1. Study with Patient Charges 2. 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 – Operating Room – Anesthesia – Recovery Room – Medical Supplies – Physician Pro Fee – Anesthesia Pro Fee $245 $1171 $585 $1272 $186 $1596 $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