Remote clinic/patient monitoring for multicenter trials

Clinic monitoring is essential for the quality control of multicenter clinical trials. In studies of eye diseases, certification of visual function testers is integral to such monitoring. Routine site visits, while useful for evaluating clinic performance and certifying visual function testers, are expensive and not suitable for every study. As part of the Longitudinal Optic Neuritis Study (LONS), a follow-up study of the patients entered into the Optic Neuritis Treatment Trial (ONTT), we established a central system for clinic monitoring and visual function tester certification in lieu of performing site visits. We also established a centralized and well-defined system for maintaining patient contact in an attempt to enhance follow-up visit compliance. Both have been used over the first three years of the LONS. Coordinators at two of the participating clinical centers were selected to serve as regional coordinators; each was responsible for overseeing seven or eight clinics and 200 patients. Annually by phone these coordinators perform certification of each technician's visual function testing. Clinic monitoring is performed by monthly phone calls. Conference calls involving each clinic's personnel, the regional coordinator, and Data Coordinating Center personnel are held one or two times per year. Patient phone contact at four-month intervals between annual patient exams is done to evaluate visual and general health status, to review study information, and to coordinate and encourage annual protocol exams at the respective centers. This system has helped achieve a visit completion rate of over 90% for active study patients. Patient phone contact by the regional coordinators has been well received. Telephone certification of visual function technicians by the regional coordinators appears to be as effective as on-site certification. Clinic performance appears to be continuing at the same high level as during the period of annual site visits. Although site visits are valuable for clinical trials, if routine site visits are not feasible the methods we have implemented for remote monitoring may be useful. (C) Elsevier Science Inc.