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Budgeting for a Diverse Clinical Trial

NIMICT Original

Budgeting for a Diverse Clinical Trial

Budgeting Basics

Key questions to ask yourself and team members

  • What will generate expenses?
  • What is the trial duration?
  • What is the patient burden?
  • What is the number of sites?
  • What is the accrual goal?

Components of a Successful Budget

Research Personnel

  • Full-time coordinator and research staff members
    • Language requirement?
    • Competitive salaries will attract experienced recruiters
  • Support for administrative staff at your institution and/or collaborating organizations           
  • A community advisory groups can be consulted to vet study design (often includes a fee or honorarium)

Reducing Patient Burden

  • Reimbursement for transportation, parking, meals
    • For urban settings, provide a fixed amount on a transit card
    • For longer distances, provide mileage reimbursement
  • Depending on duration of follow-up, you may need to account for childcare services and/or lodging
  • Providing gift cards to local grocery store or movie theater is a best practice
  • Consider providing after hours coverage and offering flexible follow-up visits

*All suggestions must be first approved by your program officer and institution’s IRB.

*Must be itemized in submitted budget

Recruitment

  • Passive methods: direct mailinings, mass media outlets (e.g., newspaper postings, radio and poster announcements)
    • Posters and brochures in the waiting room are a best practice
  • Active methods: telephone calls and interpersonal communication
    • Remember, on average, it took 4 in-person visits to get a "Yes."
  • Coordinator training (e.g., cultural competency)
  • Translation services, translators, and bilingual staff are essential for non-English speaking populations

Retention

  • Study memorabilia (e.g., mugs, magnets, pens, bags) improve retention rates
  • Sending birthday and holiday cards is a best practice
    • Important to include phone number to call in case of change in address, contact information, or health status
    • Photo of the research team improves recognition and personal connection
  • Successful retention of staff members can increase patient retention rates
  • Provide a contact line for patients and providers
  • Hold recognition events for community members and participants

*As a general best practice, it is critical to communicate which procedures and tests are covered under Standard of Care and how insurance including Medicare/Medicaid would cover the costs
*Don't forget about budgeting for a "rainy day" or hidden costs!

 Budget and Trial Mechanics