Highlights

Lessons learned during the start-up of a minority-based clinical trials program follow the basic tenets of a successful business model.

Why this item may be useful

This academic medical center case study demonstrates the challenges encountered and lessons learned in establishing a NCI-supported Minority-Based Community Clinical Oncology Program (MB-CCOP). Despite programmatic strengths, successful accrual of sufficient numbers of minority patients was a challenge. Key lessons learned include: 1) there must be an unmet need, 2) an intensely dedicated leader is required, 3) the leader must assemble a core team committed to working toward program success, 4) the leader must convince financial stakeholders to provide financial and programmatic support, 5) the leader must keep the team together and have the authority to reward or remediate performance. 

Details

• The article includes tables that list specific organizational strengths, challenges to clinical trial enrollment, and recommendations. Each table is categorized under patient-based, physician-based, and institution-based issues.
• Key recommendations for programs considering applying for government funding include:
  • ​Demonstrate extensive experience providing care for patients from minority groups and enrolling them onto clinical trials.
  • Resolve issues related to obtaining translated informed consent with the institutional review board before considering application.
  • Have physician committment to refer all eligible patients.
  • Institutional and system-wide support must be in place to ensure success.