Managing Clinical Trials Contracts Budgets and Finances of IndustrySponsored

“Managing Clinical Trials: Contracts, Budgets, and Finances of IndustrySponsored Clinical Trials” Paige Dunion, Business Office Manager Clinical Research Services, Sylvester Cancer Center DISCUSSION • Clinical Trial Agreements (CTAs) • Drafting Clinical Trial Budgets • Budget Negotiation • Clinical Trial Management Clinical Trial Administration GETTING STARTED • Begin with Sponsor’s CTA template • Research Administration should review all CTAs • Good reviews take time – send to Research Administration as soon as possible KEY INGREDIENTS • CTA should be between Sponsor and University of Miami • Confidentiality limited to 5 years when possible • Include Payment Information and Tax ID • Notices to Institution should be sent to Dr. Altman MORE KEY INGREDIENTS • Termination should be by “either party” • Governing Law = State of Florida • Arbitration is NOT allowed • Include clear and detailed Payment Schedule MORE KEY INGREDIENTS • Indemnification – is usually reciprocal • Insurance coverage – is usually reciprocal • Statement regarding subject illness or injury – who will pay for illness or injury that is a direct result of study participation MORE KEY INGREDIENTS Investigator-initiated study CTAs without Indemnification/Insurance/Injury language need a waiver from Dr. Altman’s office • Submit waiver request to Res. Admn. when CTA is ready for execution • Submit packet including: copy of CTA, IRB approval letter, approved consent form, and Protocol • Research Administration will submit it to Dr. Altman’s office for you HELPFUL HINTS: • When possible, correspond with Sponsor electronically - By email - Through redlined versions of CTAs • Review payment schedule and negotiate if it is unfavorable • Request that you are notified when payments are made to lockbox; have Sponsor send you copy of check or other backup when possible • Use previously negotiated CTAs with Sponsor when possible • Use Master Agreements – Reviewed by the General Counsels office Clinical Trial Administration GETTING STARTED • Get budget template or per patient amount from Sponsor • Don’t use their template until after you’ve done your own budget • Draft your own internal budget KEY INGREDIENTS • Review Protocol • Look for special costs • Pharmacokinetics and Pharmacodynamics • Identify special pricing needed for budget MORE KEY INGREDIENTS • Invoice items • Screen failures • Write down your questions for Sponsor and PI as you review protocol • Effort for Co-Investigators or special professional services MORE KEY INGREDIENTS SALARY • PI Effort • Research Nurse; Clinical Research Coordinator; Data Management - Determine how many hours per patient - Time for monitoring visits, audits, queries MORE KEY INGREDIENTS START UP FEES • Initial IRB fee and Compliance fee • Preparation/Submission of protocol for IRB • Budget and Contract effort • PI/Staff time for protocol review, in-services, special training STANDARD OF CARE VS. RESEARCHRELATED MEDICARE RULES MEDICARE WILL NOT COVER: • Investigational Agent or device • Tests/procedures done solely for purpose of research • Tests/procedures done solely to determine eligibility STANDARD OF CARE VS. RESEARCHRELATED MEDICARE RULES MEDICARE WILL COVER: • Standard of care tests/procedures • Items or services needed for investigational agent • Tests/procedures done to monitor effect or safety AFTER BUDGET IS IN DRAFT FORMAT • Price out budget • Meet with PI to determine Standard of Care • Compare your internal budget to the Sponsor’s • Convert your budget to their template if required Clinical Trial Administration HELPFUL HINTS: • Be a tough negotiator • Never submit budget proposal to Sponsor without knowing their offer first – if they won’t give you a number, shoot HIGH • Know your budget and costs and be ready to justify • When justifying administrative costs – AVOID too much breakdown detail. It leads to the “nickel and dime” HELPFUL HINTS: • Be familiar with your previous budgets with the same Sponsor or for similar studies • Indirect costs for industry sponsors is typically reduced to 25% - don’t accept less • Can re-budget – don’t be afraid to ask for more money or invoice items down the road HELPFUL HINTS: START UP FEES • Non-negotiable • Non-refundable • Payable upon execution of CTA HELPFUL HINTS: INVOICE ITEMS • Tests/procedures as needed • IRB fees (Initial review, continuing reports, amendments) • Spanish and Creole consent form translations – including WIRB approval fees Clinical Trial Administration ONCE STUDY IS OPEN TO ACCRUAL • Complete UMHC Research Study Agreement • Send agreement to Luis Jimenez at Fax: 243-5188 • Complete JMH Provider Account form • Send form, protocol, IRB approval and consent form to Ann-Lynn Denker for approval • Once approved, send the form, IRB approval and consent form to Cleveion Ferguson to create Provider Account and cards RESEARCH BILLING • Complete the UMHC Study Patient Registration form • Form must be completed for every research patient visit • Send to Luis Jimenez in registration 1-2 days prior to visit and the patient will be pre-registered as a research patient RESEARCH BILLING Special cases - when research charges and standard of care take place on same day of service • Study-specific billing forms • Send billing form on day of service to Henaly Gonzalez in UMHC Business Office; Fax: 243-5295 • Henaly sends standard of care charges to insurance and research charges to study HELPFUL HINTS: INVOICING • Follow patients’ progress through study and track against payment schedule to determine how much money has been earned • Invoice promptly for met milestones and invoice items HELPFUL HINTS: ACCOUNTING • Consider a pharmaceutical default account to allow deficit spending while accrued funding is pending receipt • Keep copies of all expense and revenue backup • Create account statements to demonstrate aspects of sponsored account that FRS/DMAS cannot show STUDY CLOSURE Withdrawal of protocol prior to CTA execution: • Attempt to recoup costs to date When there was no patient accrual: • Attempt to recoup costs for actual expenses or salary effort STUDY CLOSURE Account closure • Complete all transactions • Ensure all staff have completed effort on trial • Return any unearned advance monies as specified per contract • Close account with Sponsored Programs QUESTIONS