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Purpose: Project management for multi-institutional, multi-site clinical trials poses significant challenges. We describe the response to challenges encountered in a 5-year National Institutes of Health multi-institutional 7-site randomized controlled trial of type 2 diabetes (T2DM) self-management interventions study.
Methods: The collaborating institutions consisted of a large 220,000-member integrated healthcare system and a university academic health science center partner. The clinical team comprised the principal investigator and research coordinators covering 6 of the 7 clinical sites, while the academic team comprised the co-principal investigator, coinvestigators, and other research and clinical coordination staff. Subjects recruited for the study had a glycosylated hemoglobin ≥ 7.5 within the last 6 months and received primary care at the participating clinics. Patients who met the inclusion criteria were consented at private orientation meetings, randomized into one of 4 study arms, and followed every 6 months over a 24-month period for data collection.
Results: The encountered challenges concerned: 1) communication across the multiple clinic sites; 2) multiinstitutional coordinator training; 3) multiple record-keeping methods; 4) clinical access for academic personnel; 5) unanticipated clinical coordinator turnover; 6) subject recruitment and retention; and 7) multiple Institutional Review Boards (IRBs). Solutions included conducting full team weekly or bimonthly research meetings, coordinator crosstraining, adding study-specific templates with downloadable fields, developing a protocol for working with single point of contact in each clinic, securing commitment from the centralized clinical system to dedicate coordinator(s) to the project for the duration of the study period, setting explicit monthly recruitment goals for each clinic, and establishing a lead IRB up-front.
Conclusion: Our challenges reflect the complexity of clinical trial collaborations across clinical and academic partners. Of critical importance to the success of clinical/academic collaborations is the commitment by all institutions for advance determination of communication strategies, IRB processes, records access and storage systems, and online training needs.
Trial Registration Number/Site: NCT01221090, https://clinicaltrials.gov