The University of Rochester (UR) and its neuroscience investigators have a long and productive track record in the experimental therapeutics of neurological disorders. We currently have 39 ongoing clinical trials covering a broad range of common and rare diseases affecting adult and pediatric populations. We have over 40 potential co-investigators with experience as clinical trial site investigators, as well as expertise in all aspects of trial design and conduct. Our site resources include the University of Rochester's Clinical and Translational Science Institute (UR-CTSI), the Center for Human Experimental Therapeutics (CHET), and our training program in experimental therapeutics. We are a dominant provider of neurological care in Upstate New York in both the inpatient and outpatient settings with referral networks that have regional, national, and international reach. We have developed a leadership and oversight infrastructure to allow for the nimble, efficient and high-integrity implementation of shared Network and non-Network clinical trials. We have secured institutional leadership commitments that include the use of a central Institutional Review Board (IRB) and the adoption and implementation of master trial agreement templates. We have developed a comprehensive plan to develop and sustain relationships with patient groups, local practice networks, and regional referral resources to optimize enrollment, recruitment and retention with an emphasis on underrepresented minorities. We also have in-place training and mentoring plans to ensure a healthy pipeline of clinical trialists and coordinators, as well as a detailed quality plan to promote ever-improving performance. As a result, we are well-positioned to partner with other centers and the NIH, and to work with the Data and Clinical Coordination Centers, to implement and develop early-stage clinical trials, covering a broad range of disease entities, whether from academic, foundation or industry discoveries. The UR-NEXT site, as a single center and member of the NEXT Network, can make major contributions to neuroscience therapeutic development and bring the trial enterprise to a new level.
Randomized clinical trials are essential for the translation of scientific discoveries to improve the health of patients with neurological diseases. As a clinical trial research site, the University of Rochester and its neuroscience investigators have the experience and expertise to implement and develop early-stage clinical trials to improve the lives of patients and families with neurological diseases. NOTE: The critiques and criterion scores from individual reviewers are provided below in an essentially unedited form. These were prepared prior to the review meeting and may not have been updated or revised subsequent to the discussion at the meeting. Therefore, they may not fully reflect the final opinions of the individual reviewers at the close of group discussion or th final majority opinion of the group. The Resume and Summary of Discussion above summarizes the final outcome of the group discussion.