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A mobile clinical trials unit improved Alzheimer's research visibility and participation but faced significant costs and logistical challenges, leading to its retirement. Future use involves transferring the unit to another team.

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Area of Science:

  • Clinical Trials
  • Neurodegenerative Diseases
  • Mobile Health

Background:

  • Established a mobile clinical trials unit in 2016 to boost Alzheimer's disease clinical trial enrollment in Florida.
  • Aimed to increase community engagement and access to research opportunities.

Purpose of the Study:

  • Evaluate the successes and failures of a mobile clinical trials unit.
  • Analyze financial viability and operational challenges.
  • Determine the future of the mobile unit.

Main Methods:

  • Retrospective review of unit operations, including successes and failures.
  • Analysis of revenue versus expenditures.
  • Assessment of participant feedback and sponsor interest.

Main Results:

  • Positive outcomes: Increased community visibility, positive participant feedback, higher appointment requests, and some trial enrollment increases.
  • Significant challenges: High operational costs (>$100k expenditures vs. $27k revenue), maintenance issues, sponsor hesitancy (especially for monoclonal antibody trials), regulatory hurdles (FDA 1572s), and logistical complexities.
  • The unit retired due to financial unsustainability and operational barriers, particularly with evolving trial drug types.

Conclusions:

  • Mobile clinical trials units offer benefits for community outreach and observational studies.
  • Operational costs, maintenance, and lack of consistent funding/revenue streams pose significant challenges.
  • The semi-mobile unit was retired due to financial and logistical issues, with plans to transfer it to another institutional team.