Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care

Abstract

Researchers conducting clinical trials in multiple clinical sites with targeted populations face significant management challenges to maintain data integrity, while obtaining and retaining an adequate sample. These challenges can be further compounded when multiple institutions are involved, such as an integrated healthcare system and an academic-based partner. For example, communication among project team members can present a challenge to management of multi-site collaborations. Richards described communication as "the force that allows groups to take on their own identity" [1]. Effective communication for a research team is generally thought to be a function of pre-planning, adaption to various leadership styles, and organizational commitment [2-4]. However, a multi-site clinical trial does not necessarily fit the traditional hierarchical organizational model [3,5]. Within each clinical site, between clinical sites, and between clinical and academic collaborators, there must be common management strategies in place. Multi-site and multi-institutional studies present the added communication challenges of travel distance and time. Whether they are a clinic or academic employee, research coordinators, in particular, have significant responsibility for organizing and overseeing a site's participation in multi-site clinical trials. Few organizations have exactly the same training requirements for coordinators and, as the number of clinical trial sites increases, these variations can present challenges in trial management. Training variability has the potential to create discrepancies among study staff regarding operating procedures, data collection, and record-keeping. A high degree of control in protocol implementation, data collection, and reporting has been identified as a key component in successfully managing multi-institutional randomized controlled trials (RCTs) and can be achieved, in part, through standardized training requirements [3,6].

The CANadian Pediatric Weight management Registry (CANPWR): lessons learned from developing and initiating a national, multi-centre study embedded in pediatric clinical practice

“…The observed challenges of conducting multi-site clinical trials [ 10 ] are also relevant to observational studies such as CANPWR. As highlighted, specific requirements and length of time for approval from research ethics boards can vary site-to-site.…”

Effective Project Management of a Pan-African Cancer Research Network: Men of African Descent and Carcinoma of the Prostate (MADCaP)

“…28 Key challenges in the project management of multi-institutional, multicenter, clinical research studies include project team communication, staff training, efficient and accurate record keeping and data integrity, research staff access to clinical areas, staff turnover, participant recruitment and retention, and navigation of institutional review boards and other regulatory bodies. 29 Site-specific adaptations are also key to a successful outcome, particularly when studies are conducted in multiple countries. In the current study, one center created a cross-center intervention committee to review and approve initial protocols, proposing adaptations and the implementation of intervention components throughout the study lifecycle.…”

Experience of establishing and coordinating a nationwide network for bidirectional intussusception surveillance in India: lessons for multisite research studies

“…Multicentre studies face several challenges related to design, site selection, regulatory approvals, study conduct, coordination, data management and dissemination. [17][18][19][20] The lessons from multisite studies in India are limited. The intussusception surveillance study has been successfully completed and the network has evolved over time to undertake more vaccine safety studies.…”