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The POINT trial is a partnership between the Clinical Coordinator Center (CCC) based in the UCSF Stroke Sciences Group (SSG), and the NINDS NETT Network, which will be responsible for data management and oversight of NETT sites, and the Clinical Research Collaboration (CRC), which will manage the non-NETT sites.
The UCSF SSG
Directed by Dr. S. Claiborne Johnston, involves 30 faculty and staff with expertise in study design, epidemiology, biostatistics, nursing, and study coordination. It has coordinated multicenter observational studies and clinical trials for the last decade and is co-PI with Dr. J. Donald Easton, who has vast experience working on complex multicenter stroke trials.
NETT Clinical Coordinating Center (U. Michigan)
The NETT CCC provides a large number of ready sites on line to do acute neurological studies. The coordination of NETT is already sponsored by the NINDS but study specific costs are not. The relationship with the NETT has been secured with a contractual arrangement.
The NETT CCC is housed in the Department of Emergency Medicine at the University of Michigan, Medical School in Ann Arbor, MI. It is directed by Dr. William Barsan, the NETT CCC Principal Investigator, with the assistance of NETT-CCC investigators and staff. The NETT-CCC Site Manager oversees the day-to-day activities of clinical sites in the NETT Network, and coordinates communication of trial activities (e.g., meeting and teleconference arrangements).
NETT Statistics and Data Monitoring Center (Medical University of South Carolina)
POINT is using the the NETT SDMC which is housed in the Data Coordination Unit (DCU) in the Division of Biostatistics and Epidemiology (DBE) at the Medical University of South Carolina (MUSC) in Charleston, SC. The Division is directed by the PI of the NETT SDMC, Yuko Palesch, Ph.D., and the DCU is directed by Valerie Durkalski, Ph.D., who is the co-PI of the NETT SDMC. Catherine Dillon, who is the supervisory Data Manager in the DCU, oversees the data management activities at the NETT SDMC. The responsibility of the NETT SDMC is to provide statistical design and analysis of the POINT study, liaise with the DSMB, and to provide efficient web-based data management. NETT SDMC is in full compliance with the ICH-GCP Guidelines and FDA regulations for conducting clinical trials.
Through its NETT SDMC, the NETT will provide reports to the DSMB and medical safety monitors, shielding the UCSF CCC and NETT CRC from access to unblinded data during the performance of the trial. The Director of the NETT SDMC will be responsible for the randomization protocol, final statistical analysis plan and final data analysis.
POINT Clinical Research Collaboration (The EMMES Corporation, Rockville, Maryland)
The EMMES Corporation, under contract with UCSF, serves as the POINT CRC Operations Center. In its role as the Operations Center for the NINDS sponsored Clinical Research Collaboration, EMMES has been working with hundreds of practice-based physicians to assist in research training and participation. All CRC participants interested in POINT participation have been invited to consider becoming certified for the study. The POINT CRC is directed by Anne Lindblad, PhD. Site identification and activation is directed by the CRC Operations Center and CRC protocol specialists serve as site resources for IRB submissions, data timeliness and accuracy.