Yuko Y. Palesch, PhD

A multitude of networks supported by the NIH now exists to maximize efficiencies to develop, promote and conduct high-quality, multi-site clinical trials.  The efficiencies are gained from establishing and maintaining an infrastructure that consists of coordinating center(s) and multiple clinical sites that enroll patients into the multiple, concurrently ongoing trials.

Currently, the National Institute of Neurological Disorders and Stroke (NINDS) funds four networks to conduct clinical trials, one of which is the NeuroNEXT managed by the Massachusetts General Hospital (for clinical coordination) and the University of Iowa (for statistics and data management).  The other three – Neurological Emergencies Treatment Trials (NETT), Stroke Trials Network (NIH StrokeNet), and Strategies to Innovate Emergency Care Clinical Trials (SIREN) – are managed operationally (i.e., project management and network coordination) by the University of Michigan (NETT and SIREN) and the University of Cincinnati (StrokeNET). The Medical University of South Carolina (MUSC) acts as the statistics and data management center (SDMC) for all three.

The lecture briefly describes the three networks and presents the experiences of the Data Coordination Unit at the MUSC in establishing and managing the SDMCs, comparing and contrasting the three networks with respect to the infrastructure and processes of developing projects, obtaining funding, and implementing clinical trials.  In addition, the expanded roles of the SDMC statisticians, above and beyond analyzing data, in the networks are discussed.

With each network, there have been growing pains, along with addressing and complying with new rules and regulations (e.g., single IRBs, grant submission formats, etc). The magnitude of the networks as well as of the projects also have posed some challenges (“trials”).  Nevertheless, the realization of efficiencies in initiating and managing clinical trials through the networks are emerging.  Furthermore, participating in the three networks has provided the MUSC statistical and information systems teams with great opportunities to be informed and be innovative in designing and conducting clinical trials (“jubilation”).