Experiences of the NINDS clinical research collaboration with the use of a virtual coordinator
Year of Publication
Burke, C; Lindblad, A
Annual Meeting of the Society for Clinical Trials
The Chronic Migraine Treatment Trial was a randomized double blind placebo controlled trial to test the efficacy of combination prophylactic therapy in chronic migraine patients. This study offered a virtual clinical research coordinator to sites which, due to a lack of staffing resources, may not otherwise have been able to participate in research. The CRC virtual coordinator was to collaborate with investigators and subjects from each site requesting such services by performing the traditional role of a clinical coordinator remotely from the NINDS CRC Operations Center. Specifically the virtual coordinator was available to assist the physician with CRF completion, data entry, informed consent process, subject follow-up and protocol adherence. Four of the 70 activated centers elected to utilize this option. One of these centers enrolled 14 subjects and randomized 6 subjects; one screened 3; one screened 1, and one site failed to screen a single subject. The site that randomized 6 subjects was in the top 20 percent of enrolling sites. Challenges to implementing this approach included: “ Completion and storage of source documentation that ensured site staff and the virtual coordinator have access to current study subject information while maintaining confidentiality “ Coordinating schedules for study visits and virtual coordinator availability between the subject, the clinic site, and the CRC coordinator “ Ensuring that all consent procedures and study activities were completed for each subject “ Ensuring that site staff appropriately determined eligibility prior to forwarding subject contact information to the virtual coordinator “ Minimizing the potential for discrepancies between the coordinator and physician The virtual coordinator model allowed physicians to actively and productively participate in research. The challenges with the virtual aspect are ones that are unlikely to be conducive to wide spread adoption of this approach.