Utilizing a mobile clinical trials unit: Lessons learned from the first three years

• Published in: Alzheimer's & dementia Vol. 16
• Main Authors: Smith, Amanda G., Rodrigo, Kelly, Lowe, Patricia, Andrade, Melissa, Burnett, Elisabeth, Vasquez‐Ramos, Myriam, Mba, Ijeoma, Janavs, Juris, Major, Beth, Epstein, Patricia, Wynne‐Phillips, Heather, Flynn, Myrna DeJesus, Morgan, Dave
• Format: Journal Article
• Language: English
• Published: 01-12-2020
• ISSN: 1552-5260; 1552-5279
• DOI: 10.1002/alz.037099

Background
It is well‐established that clinical trials for Alzheimer's Disease need faster enrollment. Transportation challenges can sometimes prevent potential subjects from participating in clinical trials. In Florida, many persons live more than 30 minutes from sites conducting clinical trials. Based on these facts, we created a mobile clinical trials unit that launched in the 2nd half of 2016.
Method
We created a mobile clinical trial unit on which all trial screening activity other than imaging could be performed. It is a 53' trailer with 400 square feet of space and allows for all aspects of study visits other than imaging to be conducted on it. We reflected upon the successes and failures of the last three years of experience with the unit with the team members who staff it. We also documented feedback from sponsors and participants.
Result
We have previously reported that the mobile unit increased the number of minorities participating in memory screening at Health Fairs (CTAD 2016) and doubled the number of participants we screened in prevention trials (AAIC 2018.) Additional positive findings include increased visibility in the community, feelings from subjects that we were making an effort to accommodate them, increased request for appointments in our clinic, increased enrollment in treatment trials compared to our main clinic alone, and national and international interest in expanding the concept. Challenges included cost of moving the unit and need to use a trucking company to do so, space requirements for parking, unexpected maintenance issues and associated costs, hesitancy of sponsors to adopt the concept, need for development of unit‐specific SOPs, staffing issues, and additional work & accountability transporting study materials such as drug, source documents, and labs.
Conclusion
There are both pros and cons associated with the operation of a mobile clinical trials unit, especially when the unit itself is only semi‐mobile. Nevertheless, it has thus far ultimately been successful in expanding our pool of subjects across the spectrum of AD and increasing trial participation.