Budgeting for a Diverse Clinical Trial

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!