PRCSG Training Webinar: Budget for Industry Sponsored Studies Anne Johnson, Senior Specialist-Project Management Cincinnati Children’s Hospital Call in: 1-866-629-4752 Passcode 502017#

Outline Start up costs overview Comparative start up costs – 3 clinical trials Routine study visit costs Conclusion

Start up costs (1) IRB fees Average initial submission for a local IRB $3500 Average fee per amendment approval $1250 Average fee for continuing review $2000 The initial submission fee and the time/labor costs needed for the submission packet to be completed are usually included in the start up costs provided before the study starts. The amendment and annual review fees usually have to be invoiced separately as they occur.

Start up costs (2) Pharmacy fees Average start up fees for investigation pharmacy are $3,500. Every visit usually incurs an additional dispensing fee. Check with your pharmacy about fees for drug reconciliation and policies for return of used and unused drug at every study visit. Pharmacy staff should take care of their own delegation log and study forms for drug receipt, dispensing, reconciliation, and destruction.

Start up costs (3) Administrative start up fee can range from 5-10K depending on the sponsor. Regulatory coordinator time to collect and file necessary “reg docs” (1572, delegation log, CVs, licenses, HSP training, financial forms) Time needed to write consents per site and sponsor templates, IRB submission documents Training followup for protocol, IB, pharmacy manual for all staff listed on the delegation log

Start up costs (4) Will you use a clinical trial research center? Costs and time for application. Sometimes the CTRC requires a protocol application in addition to the IRB submission. The hourly costs for CTRC use can either be under your “other costs” section of the contract (need to be invoiced) or included in the patient per visit costs.

“Other costs” Some contracts will offer close out fees as well as start up fees. Check your contract for other costs that must be invoiced to collect payment. Screen failures pK sampling if not included in the patient visit costs

Comparative start up costs by sponsor Local IRB fees $3,500 actual $4,000 IRB amendment fee $1,250 IRB annual review $2,000 Admin start up $10,385 $12,750 $6,500 IRB document prep none $1,200 Pharmacy start up $2,500 Lab set up $550 Screen fails $921 $1,619 Close out fee Additional samples $40 $300 $95 Record retention $1,360 Total start up costs $20,596 $20,660 $12,214

Routine study visit costs Schedule of events should be broken down by visit in the contract to show what needs to be done when and how much the sponsor will pay for the activity. These costs are usually paid directly once the visits are completed and entered into the EDC. No invoice is needed to collect these payments. It is a good idea to double check these activities with your clinic practice procedures. Most hospitals require a breakdown of research vs. standard of care charges for study visits.

Routine study visit typical costs (1) Informed consent/parent permission/assent and complete medical history $150-$200 Uveitis assessment (slit lamp exam) $100 Complete physical exam (baseline and pivotal time points) $300-$400 Partial physical exam (other time points) $250 Tanner stage (usually done twice-baseline and last visit) $75-$100 Quantiferon-TB (blood test) done at baseline or screening visit and possibly yearly $75-$100

Routine study visit typical costs (2) Complete joint evaluation by certified assessor (sometimes blinded depending on protocol) $75-$125 Physician Global Evaluation of Overall Disease Activity $50-$75 Subject Reported Outcomes CHAQ CHQ PedsQL Pain and global evaluations $35-$50

Routine study visit typical costs (3) ESR or CRP (marker of inflammation)- this could be onsite testing or collection and shipping to central lab, prices vary by process $25-$50 Sample collection, processing, and shipping for central lab $50-$80 Study Treatment management Review patient diary, answer questions Collect used/unused IP, reconciliation records Pharmacy orders and returning used/unused IP Dispense new IP to patient $85-$100

Routine study visit typical costs (4) Study Treatment management (continued) If IP is by injection, some protocols require that the subject administer while in clinic and then wait 30 minutes for repeat vitals If IP is by infusion, this extra cost for CTRC or infusion center might be included in the visit charge or might be listed under “other costs”. Make sure the cost of the infusion is listed somewhere in the contract. Typical infusions take 30-60 minutes and then need repeat vitals.

Routine study visit typical costs (5) Study Coordinator Fees Confirming eligibility criteria with PI Consenting procedures Prior/concomitant meds Vital signs, height, weight, possible repeat vitals after IP administration will be needed Randomization Submitting assessments to PRCSG for some studies and some visits AE/SAE review, monitoring with PI $150-$200

Routine study visit typical costs (6) Data entry into EDC $100-$150 Subject/caregiver travel reimbursement (depends on protocol and time spent on site) $50-$100 PK sampling might be part of protocol $40-$50 Urine or blood pregnancy tests for WOCBP, depending on protocol, every time new IP is given or as requested by sponsor $50

Routine study visit typical costs (7) Total costs should be listed per visit and then per patient Costs should be listed with and without overhead

Conclusion Repeat webex September 13, 11am Questions? Comments? Proposed topics for future webex training? prcsg@cchmc.org