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Abstract Details

Network for Excellence in Neuroscience Clinical Trials, NeuroNEXT: Concept to Implementation
Neurologic 好色先生
P04 - (-)
245
BACKGROUND: In Oct 2011, NINDS awarded the Clinical Coordinating Center (CCC) grant to MGH, the Data Coordinating Center (DCC) grant to the University of Iowa, and Clinical Study Sites (CSS) grants to 25 academic institutions. Three novel initiatives to increase the efficiency of conducting clinical trials in the Network were proposed: utilization of a Central IRB (CIRB) of record, establishment of Master Clinical Trial Agreements (MCTA) with all CSS, and availability of experienced trial design staff to assist principal investigators.
DESIGN/METHODS: The CCC and DCC developed 50 Standard Operating Procedures for Network operations. The CIRB held teleconferences and one in person meeting with IRB leaders from the CSS. In Oct 2011, the NeuroNEXT Executive Committee (NEC) was established and began reviewing proposals. Those that met the goals and mission of NINDS, and were approved by the NEC, then proceeded to a Protocol Working Group (PWG) with the objective of designing the strongest protocol and grant application.
RESULTS: All CSS executed Reliance Agreements with the CIRB (mean 25 days, range 1 to 43 days), and MCTA (mean 50 days, range 4 - 168 days). The first funded study was announced in April 2012. The study was submitted to the CIRB for full review on July 18th, and received full CIRB approval on Aug 21st, 2012. In year 1, 60 proposals were submitted to NINDS, 32 submitted to the NEC and 18 PWG were formed. Four grant applications were submitted to NINDS for review; with an additional 8 expected in Dec 2012.
CONCLUSIONS: The NeuroNEXT Network has successfully established infrastructure that will greatly increase the efficiency and quality of clinical trials.
Authors/Disclosures
Marianne Kearney
PRESENTER 		No disclosure on file
Dixie J. Ecklund, RN (University of Iowa) The institution of Ms. Ecklund has received research support from NIH. The institution of Ms. Ecklund has received research support from Michael J. Fox Foundation. Ms. Ecklund has received personal compensation in the range of $500-$4,999 for serving as a Scientific Review Board with Department of Defense. Ms. Ecklund has received personal compensation in the range of $500-$4,999 for serving as a Consultant with Northwestern University.
No disclosure on file
Michael J. Bosch, RN (University of Iowa College of Public Health) No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Brenda Thornell (Massachusetts General Hospital) No disclosure on file
Sarah Titus No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Michele Costigan, RN (University of Iowa College of Public Health) Ms. Costigan has nothing to disclose.
No disclosure on file
No disclosure on file
Jeremy M. Shefner, MD, PhD, FAAN (Barrow Neurological Institute) Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amylyx. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Uniqure. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clene. Dr. Shefner has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Cytokinetics. Dr. Shefner has received personal compensation in the range of $0-$499 for serving as a Consultant for Mitsubishi Tanabe Pharma America. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for annexon. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurosense. Dr. Shefner has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuvivo. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nura BIo. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Prilenia. Dr. Shefner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for swanbio. Dr. Shefner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for vertex. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Shefner has received personal compensation in the range of $50,000-$99,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for UpToDate. The institution of Dr. Shefner has received research support from NIH. The institution of Dr. Shefner has received research support from Mitsubishi Tanabe Pharma America. The institution of Dr. Shefner has received research support from Amylyx. The institution of Dr. Shefner has received research support from BIogen. The institution of Dr. Shefner has received research support from Cytokinetics. The institution of Dr. Shefner has received research support from IONIS. The institution of Dr. Shefner has received research support from Healey Center for ALS. Dr. Shefner has received personal compensation in the range of $500-$4,999 for serving as a grant review chair with DOD- General Dynamics.
Laurie Gutmann, MD, FAAN The institution of Dr. Gutmann has received research support from NIH. The institution of Dr. Gutmann has received research support from Harmony . Dr. Gutmann has received publishing royalties from a publication relating to health care.
William R. Clarke, PhD (The University of Iowa) No disclosure on file
James C. Torner, PhD (University of Iowa) The institution of Dr. Torner has received research support from NIH.
Jeffrey D. Long Jeffrey Long has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Triplet. Jeffrey Long has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vacinnex. Jeffrey Long has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Wave. Jeffrey Long has received personal compensation in the range of $0-$499 for serving as a Consultant for PTC. Jeffrey Long has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Jeffrey Long has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Jeffrey Long has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for uniQure. Jeffrey Long has received research support from NIH DSMB.
No disclosure on file
No disclosure on file
Dawn E. McNeil, MD (McNeil Pediatric Therapeutics Consultancy) Dr. McNeil has received personal compensation for serving as an employee of Bluebirdbio .
Walter J. Koroshetz, MD, FAAN (Dana Foundation) Dr. Koroshetz has nothing to disclose.
Petra Kaufmann, MD, FAAN (Affinia Therapeutics) Dr. Kaufmann has received personal compensation for serving as an employee of Affinia Therapeutics. Dr. Kaufmann has received personal compensation for serving as an employee of Vigil Neuroscience. Dr. Kaufmann has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for DTx. Dr. Kaufmann has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Taysha Gene Therapies. Dr. Kaufmann has stock in Vigil Neuroscience. The institution of an immediate family member of Dr. Kaufmann has received research support from Cystic Fibrosis Foundation . Dr. Kaufmann has a non-compensated relationship as a Member of a Scientific Advisory Board with NIH that is relevant to AAN interests or activities.
Merit E. Cudkowicz, MD, MSC, FAAN (Massachusetts General Hospital) Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for biogen. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for cytokinetics. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for immunitypharm. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for transposon. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quralis. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Regeneron. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for vectorY. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for inflectis. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for novartis. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ono. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for otsuka. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for coya. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ac immune. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for pontifax. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inflectis. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for ab science. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for aclipse. Dr. Cudkowicz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Locust Walk. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pasithea. Dr. Cudkowicz has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Praxis Precision Medicine. Dr. Cudkowicz has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Annals of Neurology . The institution of Dr. Cudkowicz has received research support from NINDS. The institution of Dr. Cudkowicz has received research support from ALSFAC. The institution of Dr. Cudkowicz has received research support from UCB ra. The institution of Dr. Cudkowicz has received research support from Biohaven. The institution of Dr. Cudkowicz has received research support from Clene nanomedicine. The institution of Dr. Cudkowicz has received research support from prilenia. The institution of Dr. Cudkowicz has received research support from ALS one. The institution of Dr. Cudkowicz has received research support from Seelos. The institution of Dr. Cudkowicz has received research support from Calico. The institution of Dr. Cudkowicz has received research support from denali. The institution of Dr. Cudkowicz has received research support from ITB. The institution of Dr. Cudkowicz has received research support from PharmAust. The institution of Dr. Cudkowicz has received research support from woolsley. Dr. Cudkowicz has received research support from lilly. The institution of Dr. Cudkowicz has received research support from J& J. Dr. Cudkowicz has received publishing royalties from a publication relating to health care.
Christopher Coffey, PhD, FAAN (University of Iowa) Dr. Coffey has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Heart Association. The institution of Dr. Coffey has received research support from NIH. The institution of Dr. Coffey has received research support from Michael J Fox Foundation.