Transcript Protocol Complexity: How it Affects the Bottom Line

Managing Clinical Trials For Break
Even
HEATHER OFFHAUS
DIRECTOR
GRANT REVIEW & ANALYSIS
UNIVERSITY OF MICHIGAN MEDICAL SCHOOL
[email protected]
BRIAN FARMER
Senior Director
Academic Affairs
Cleveland Clinic
[email protected]
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
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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.
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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 Investigator
 Clinical Study Nurse / Trial Coordinator
 Sponsor / CRO
(though maybe at a longer arm length!)
Extensions of Clinical Trial Team
 Billing Calendar Review Office
 Human Subjects Protection Office
 Contract Negotiation Group / Sponsored
Programs Office
 Ancillary 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 Patients
 Geographic 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 flexible
 If not in budget, sponsor is not
obligated to pay
 Must cover all costs
Categorize Budget Items
Fixed and UpFront 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)
These are a real cost to the institution
 Determine correct rate to use on your study
 Call your institutional resource!
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 / calendar
 Principal Investigator designates Standard
of Care items versus research related items
 Billing Calendar becomes the foundation of
your budget
Billing Calendar
Form to take on visit to PI to identify standard of care v. chargeable items
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 process
Increased salaries & operating costs over
time
Travel 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 funds
Audits
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”
Negotiation
 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!
Bring the Team back together
• Final Logistics Meeting
• Identifying equipment/medications/supplies
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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
On Going Financial Analysis
 Review during the study is critical
 Examine the Data Available to you
 Independent Review is Critical
 Adopt Procedures and Follow Them
 Don’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
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Prepared Centrally, Distributed by Post Award
Focus of study reports, P/L, Not Budget
FTE’s by funding (Phantoms, Labor Pools)
 Enrollment Data
 Billing Data
 Earned but Not billed
 Other Data?
Bi-monthly Budget Review
 Review of Overall Budget Performance
 Finance Personnel
 High Level Reports
 Detailed Discussion as Needed
Bi-monthly Budget Review
Sample Research P/L
Bi-monthly Budget Review
Sample Metric Report
Quarterly Reviews
 Financial Status
 Deliverable Status
 Examination of Individual Studies
 Focus
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Past End Date
Closing soon
Deficit Status
Inactive
Others
Past End Date or Closing Soon
 Financial Position
 Status of Deliverables
 Status of AR
 Status of Earned Not Billed
 Close or Extend
Deficit Status or Inactive
 Financial Status
 Billing/Payment Status
 Discuss Identified Issues
 Develop Corrective Action
 Close Study
Other Discussions for Quarterly
Meetings
 PI issues requiring intervention
 Central Office Assistance
 Sponsor Problems
 IRB Issues
 Other
Communication is Key to any Enterprise!
Other Issues: Renegotiation
 If Science is Good, Renegotiate the
Troubling Issues
 May be Better For Sponsor to ReNegotiate
 Adjust Protocol
 The Worst they can Do is Say No
 Asses Institutional Relationship with
Sponsor
Other Issues: IRB
 Good Communication with the IRB
 IRB Approved Protocols without a Study
Account Set-up (Phantom/Orphan)
 Informed Consent that Hurts Enrollment
 Renewals/Changes
Other Issues: Various
 Timing of Gain/Loss Recognition
 Research Billing
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Timing
Review of charges to studies
Error Correction SOP
 Collection from Sponsor
 Monitor Visits
 Training of Personnel (duties outside their
background)
 COMMUNICATE
Other Issues: Residuals
 Must Have Written Policy
 F & A on Residuals
 Distribution Process
 Tax Implications
 Restricted Use
 Institutional Funds
Summary
 Know your Business
 Develop Good Budgets
 Monitor
 Involve the Whole Team
 Monitor
 Work with the Sponsor
 Monitor
Communication is Key
 With PI
 With Finance
 With Billing Staff
 With Sponsor
The Entire Team,
Internal and External
Questions?

Heather Offhaus
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Director
Grant Review & Analysis
University of Michigan Medical School
[email protected]

BRIAN FARMER
Senior Director
Academic Affairs
Cleveland Clinic
[email protected]