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P2‐393: Enhancing Florida Clinical Trial Recruitment in Alzheimer's Disease Research through a Mobile Clinical Trial Unit
Author(s) -
Smith Jill S.,
Morgan David,
Smith Amanda G.
Publication year - 2016
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2016.06.1604
Subject(s) - clinical trial , unit (ring theory) , medicine , patient recruitment , disease , clinical research , schedule , family medicine , gerontology , physical therapy , psychology , computer science , mathematics education , operating system
Background:Florida has a large number of senior residential communities and an excellent series of state-supported Memory Disorders Clinics (MDCs) through the Alzheimer’s Disease Initiative. Although these clinics care for 10,000 memory-impaired cases annually, many do not have the resources or expertise to offer clinical research. Participant enrollment and retention is also impacted by problems in transportation to the clinical trial sites where patients may travel an hour or more to access the nearest clinical trial in Florida.Methods:The Byrd Alzheimer’s Institute has developed a mobile Alzheimer’s clinical trial unit that will offer potential benefits including: A) increasing the availability of Alzheimer’s clinical research, B) taking advantage of the clinical diagnosis provided by MDCs for recruitment, and C) increasing the number of clinical trial participants evaluated by the same individuals. This mobile unit could travel to retirement communities and/or MDCs that lack established facilities to conduct clinical trial research. The increased accessibility may increase long term retention of research subjects. Results:Our facility has acquired funding from the State of Florida in July 2015. As of January 2016, manufacturing has begun. Final unit delivery is expected May 2016. The mobile unit model includes: reception, exam room, two consultation/testing rooms, and a phlebotomy suite. We estimate ability to conduct 5-8 study visits daily with a team of study physician, study nurse, and two clinical raters. The unit will visit approximately 2 sites per week on a rotating schedule. Conclusion: The mobile unit provides multi-center recruitment/enrollment equal to activity of 4-5 clinical research centers. It offers sponsors the benefit of having single site for monitoring, contracts, and qualified staff to reduce variability of research data and outcome measures collected. It offers the benefit of reduced travel to potential participants and research opportunities otherwise not be available to them. We project the enrollment capability on this mobile unit for a clinical trial to be 75-100 participants, in phased enrollment across multiple locations over a period of time. We expect that sites will be located within 90 minutes of the Institute, including Sarasota, Orlando, and St. Petersburg areas, which offer diverse communities of African Americans and Hispanics.