Clinical Trials Budgeting: A Practical Perspective

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Clinical Trials BudgetingA Practical
Perspective

• Society of Research Administrators
• Georgia-South Carolina Chapter
• March 3, 2006
• Rosemary Biscardi, MBA
• Palmetto Health Research Administration

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A Practical Perspective

• Reality check
• Think like a Sponsor/CRO
• Know your costs
• Know your deal breakers
• Plan to be flexible

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Reality Check

• Create a detailed internal budget
• Use the budget as a plan
• Tool for negotiation with the sponsor or CRO
• Realize your expenses

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Reality Check

• Dont be fooled by large per-subject payments
• Contract payment schedule internal budget
• Study coordinator time and effort
• Realistic number of subjects

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Reality Check

• Always ask for study startups
• Non-refundable payments at beginning of project
• Specify clearly in the contract
• Invoice separately, if necessary

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Reality Check

• May have to turn down project
• Consider resources
• Lends credibility to site

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Sponsor Perspective

• They are usually in the process of negotiating
  budgets with all sites
• Many sites which to compare
• Convince the sponsors that there will be value
  added
• Negotiate with sponsor directly

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Sponsor Perspective

• Unaware of per-subject costs
• Underestimate study coordinator time and effort
• Scope of personnel involvement
• More difficult to negotiate for per-subject
  payments

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Sponsor Perspective

• Fully aware of startup issues
• IRB Fees, Administrative Fees, SC time, Pharmacy
  startups
• Costs associated with local IRB submission
• Easier to negotiate for these one-time payments

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Know your Costs

• Tests to be done locally cost more than usual
• Research charge billing procedures
• Extra films and reports
• Dont accept Medicare Reimbursement

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Know your Costs

• Study Coordinator Time and Effort
• Standard study coordinator rate X hours
• Great negotiating and compliance tool
• Can be regularly reassessed

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Know your Costs

• FA and other administrative costs
• 20 FA for clinical trial projects
• FA to cover indirect costs
• Administrative Fee assessed

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Know your Deal Breakers

• May decide to consider a project where costs are
  not covered
• Loss leader strategy
• To get started or to create an image
• Interest in the field

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Know your Deal Breakers

• Consider certain items to be non-negotiable
• Startups
• Policy for percentage of costs
• Be prepared to walk away

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Know Your Deal Breakers

• May have to end participation in a project
  because of a new development
• Protocol amendment
• Sponsor/CRO adding additional requirements on
  the fly
• Sponsor/CRO may be difficult to work with

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Plan to be Flexible

• Studies differ with disease, subject population,
  and sponsor
• Startup time involved
• Recruitment plan and enrollment failures
• Type of study will determine number of subjects
  to be enrolled

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Plan to be Flexible

• Be prepared for protocol amendments and
  modifications
• Effects on study coordinator time
• Renegotiate budget
• May need to reconsider participation in the
  project

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Plan to be Flexible

• Budget on one per-subject amount where possible
• Have all expenses covered in one total
  per-subject payment
• Line items in Payment Schedule for contingencies
• Invoice for payments, if necessary

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Take Away Messages

• Develop an internal budget for every project
• Use budget as a tool throughout project
• Learn effective negotiating points
• Be able to see the sponsor perspective
• Know when to say no