heather offhaus director grant review & analysis university of michigan medical school...
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HEATHER OFFHAUSD I R E C T O RG R A N T R E V I E W & A N A LY S I SU N I V E R S I T Y O F M I C H I G A N M E D I C A L S C H O O L
h m i l l s @ u m i c h . e d u
BRIAN FARMERS e n i o r D i r e c t o rA c a d e m i c A ff a i r sC l e v e l a n d C l i n i cb f a r m e r 2 @ c c f . o r g
Managing Clinical Trials For Break Even
What will I hear today?
We’ll discuss the primary issues in a financially successful clinical research enterprise
We’ll discuss the elements of a well developed budget Identify the funds on the front end by budgeting well Identify funds through negotiation
We’ll discuss some processes we use to manage financial results. Identify funds through consistent invoicing and bookwork Identify funds through careful tracking
Can I really be Financially Successful?
It has to be a Departmental/Institutional Choice
It is a Philosophical and a Process
You have to Talk about it, Get Buy-In
Define what you Mean by Financially Successful
You must Build an Enterprise
Clinical Trial Team
One of the most integrated groups
How do you surround yourself?Principal InvestigatorClinical Study Nurse / Trial CoordinatorSponsor / CRO
(though maybe at a longer arm length!)
Extensions of Clinical Trial Team
Billing Calendar Review OfficeHuman Subjects Protection OfficeContract Negotiation Group / Sponsored
Programs OfficeAncillary Review Committees
Specialized Expertise
Use your Competitive Advantage in Negotiations
Do you have Personnel, Techniques, IP that you can Leverage/
Do you Truly have Specialized PatientsGeographic Advantage
Determine Recruitment Potential
Define reasonable & realistic accrual goals
• What measures are necessary to reach the desired subject population?
• How many subjects must be screened to identify an eligible participant?
• What is the recruitment time frame?• What is my patient population?
DISCLAIMER!!!
We will talk through types of charges
We will offer many ways of looking at things
BUT, this is not the exhaustive list!
Many items are protocol/institution specific
Clinical Budget Full Budget Concepts:
Needs to be somewhat flexibleIf not in budget, sponsor is not
obligated to payMust cover all costs
Categorize Budget Items
Fixed and Up-Front Costs
Are needed for study conduct and incurred whether or not a subject is enrolled.
Costs Related to Subject Visits
Sponsor proposals usually link all budget items directly to patient visits.
Identify Universal Costs for Study Conduct
What institutional approvals are needed and need funding?
Are mandated fees charged?Determine institutional Indirect Cost
rate
Indirect Cost Recovery (aka Facility & Administrative charges or Overhead)
Determine correct rate to use on your study
Call your institutional resource!
These are a real cost to the institution
Budgeting a Clinical Trial
Clinical Trial experience is helpful when creating and negotiating budgets
• Understand the nuances of treatments
• Things are not black and white
• There is a patient at the other end of the trial
• The care always has to come first over the protocol
Dissecting the Protocol
• Study Calendar• Identify items that will generate expenses for the site
• Number and complexity of subject visits
Dissecting the Protocol
• Study Calendar• Identify items that will generate expenses for the site
• Number and complexity of subject visits
• Laboratory Assessments (Examinations)• Knowing exactly what is included in each lab cost is key
Dissecting the Protocol
• Study Calendar• Identify items that will generate expenses for the site
• Number and complexity of subject visits
• Laboratory Assessments (Examinations)
• Study Design• Study duration
• Accrual goal
• Number of participating sites
• Cycle length and/or limit
Billing Calendars
Produce list of study procedures / calendarPrincipal Investigator designates Standard
of Care items versus research related itemsBilling Calendar becomes the foundation of
your budget
Billing CalendarForm to take on visit to PI to identify standard of care v. chargeable
items
Screen Cycle 128 Day Cycle
Cycle 228 Day Cycle
Cycle 328 Day Cycle
CPT CDM Day-14 to -1 Day 1Day 8 Day 15 Day 22 Day 1 Day 8 Day 15 Day 22 Day 1 Day 8 Day 15 Day 22
OFFICE VISITS
Physical Examination 99214 26339 RC RC RC RC
LABS
Hematology - CBCPD 85025 35501 RC RC S RC S RC S RC S RC S RC S
Serum Chemistry - COMP 80053 20548 RC RC RC RC RC RC RC
Uric Acid 84550 20701 S S S S S S S
Serum Pregnancy Test 84702 23305 S S S S
Urinalysis - Macro 81003 35303 RC S RC RC
Urinalysis - Micro 81015 35303 S S S S
PROCEDURES
CT Scan - Abdomen 74160 33971 RC RC
Preparing the Budget
Salary Recovery Estimates
• Recovery Estimate Sheet for:• Principal Investigator• Additional faculty / clinician participation• Data Manager/Coordinator• Regulatory Manager/Coordinator• Research/Treatment Nurse• Medical Assistant• Multi-site Study Coordination
• Consider support for:• Finance/Accounting • IT Support for Clinical Research• Difficulty of meeting eligibility criteria• Additional recruitment effort
Consider “Hidden” Study Costs
Delayed start Informed consent processIncreased salaries & operating costs over
timeTravel to clinics or offsite locations
Hotel Stays Tolls / Mileage Meals
More “Hidden” Study Costs
Unscheduled visits Overhead costs for “a la carte” or
one-time procedures Tracking study fundsAudits
Consider Closing Costs
Don’t forget – Closing costs occur AFTER subjects complete
study and BEFORE contract ends
• Query resolution to close database• Sponsor’s close-out visit• Pharmacy close-out• IRB termination• Long-term storage of research records
Potentially Unallowable Costs:
• Finder’s fees/Referral fees
• Enrollment incentives
• Paperwork completion incentives
Feasibility Comparison
The comparison of what you truly need to what you can negotiate….
How do you identify the “institutional investment” in a project?
Always compare any sponsor offered amounts with information you have
When do you say (for financial reasons) you can’t do a study?
Negotiation
• Areas of resistance:• Study team salaries
• Start up fees
• Expensive procedures
• Procedures should be “standard of care”
Tips to overcome resistance:• Justification outline of start up fees• Increase cost of one item to reduce the cost of another• Additional invoicable items• Ask for more than you need, so you can reduce costs
and satisfy sponsor later• Clarify procedure requirements to see if a less
expensive option can be used
*Remember, the sponsor WANTS to work with you!
Negotiation
• Final Logistics Meeting• Identifying equipment/medications/supplies
provided by sponsor (Kits for labs, PK draws, etc.)
• Verifying number of patients expected to accrue
• Fielding questions/feedback from study team that need to go to sponsor in financial areas
• Logistics for conducting trial
• Reviewing draft financial terms from the sponsor
Bring the Team back together
On Going Financial Analysis
Review during the study is criticalExamine the Data Available to youIndependent Review is CriticalAdopt Procedures and Follow ThemDon’t be Afraid to Pull the Plug
Our Process
Research Budget
Include Costs of Clinical Research
Choose Proper Metrics be Transparent
Measure Performance Against Metrics
Metrics and Who is Responsible
Financial Reports Prepared Centrally, Distributed by Post Award Focus of study reports, P/L, Not Budget FTE’s by funding (Phantoms, Labor Pools)
Enrollment DataBilling DataEarned but Not billedOther Data?
Bi-monthly Budget Review
Review of Overall Budget Performance
Finance Personnel
High Level Reports
Detailed Discussion as Needed
Bi-monthly Budget ReviewSample Research P/L
Bi-monthly Budget ReviewSample Metric Report
Quarterly Reviews
Financial StatusDeliverable StatusExamination of Individual StudiesFocus
Past End Date Closing soon Deficit Status Inactive Others
Past End Date or Closing Soon
Financial PositionStatus of DeliverablesStatus of ARStatus of Earned Not BilledClose or Extend
Deficit Status or Inactive
Financial StatusBilling/Payment StatusDiscuss Identified IssuesDevelop Corrective ActionClose Study
Other Discussions for Quarterly Meetings
PI issues requiring interventionCentral Office AssistanceSponsor ProblemsIRB IssuesOther
Communication is Key to any Enterprise!
Other Issues: Renegotiation
If Science is Good, Renegotiate the Troubling Issues
May be Better For Sponsor to Re-Negotiate
Adjust ProtocolThe Worst they can Do is Say NoAsses Institutional Relationship with
Sponsor
Other Issues: IRB
Good Communication with the IRBIRB Approved Protocols without a
Study Account Set-up (Phantom/Orphan)
Informed Consent that Hurts EnrollmentRenewals/Changes
Other Issues: Various
Timing of Gain/Loss RecognitionResearch Billing
Timing Review of charges to studies Error Correction SOP
Collection from SponsorMonitor VisitsTraining of Personnel (duties outside their
background)COMMUNICATE
Other Issues: Residuals
Must Have Written PolicyF & A on ResidualsDistribution ProcessTax ImplicationsRestricted UseInstitutional Funds
Summary
Know your BusinessDevelop Good BudgetsMonitorInvolve the Whole TeamMonitorWork with the SponsorMonitor
Communication is Key
With PIWith FinanceWith Billing StaffWith Sponsor
The Entire Team, Internal and External
Questions?
Heather Offhaus Director Grant Review & Analysis University of Michigan Medical School [email protected]
BRIAN FARMERSenior DirectorAcademic AffairsCleveland [email protected]