title: Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network.
abstract: The North American Clinical Trials Network (NACTN) includes 9 clinical centers funded by the US Department of Defense and the Christopher Reeve Paralysis Foundation. Its purpose is to accelerate clinical testing of promising therapeutics in spinal cord injury (SCI) through the development of a robust interactive infrastructure. This structure includes key committees that serve to provide longitudinal guidance to the Network. These committees include the Executive, Data Management, and Neurological Outcome Assessments Committees, and the Therapeutic Selection Committee (TSC), which is the subject of this manuscript. The NACTN brings unique elements to the SCI field. The Network's stability is not restricted to a single clinical trial. Network members have diverse expertise and include experts in clinical care, clinical trial design and methodology, pharmacology, preclinical and clinical research, and advanced rehabilitation techniques. Frequent systematic communication is assigned a high value, as is democratic process, fairness and efficiency of decision making, and resource allocation. This article focuses on how decision making occurs within the TSC to rank alternative therapeutics according to 2 main variables: quality of the preclinical data set, and fit with the Network's aims and capabilities. This selection process is important because if the Network's resources are committed to a therapeutic, alternatives cannot be pursued. A proposed methodology includes a multicriteria decision analysis that uses a Multi-Attribute Global Inference of Quality matrix to quantify the process. To rank therapeutics, the TSC uses a series of consensus steps designed to reduce individual and group bias and limit subjectivity. Given the difficulties encountered by industry in completing clinical trials in SCI, stable collaborative not-for-profit consortia, such as the NACTN, may be essential to clinical progress in SCI. The evolution of the NACTN also offers substantial opportunity to refine decision making and group dynamics. Making the best possible decisions concerning therapeutics selection for trial testing is a cornerstone of the Network's function.
authors.affiliation: Department of Neurological Surgery, University of Miami, Florida 33136, USA. jguest@med.miami.edu
authors.forename: James
authors.initials: J
authors.lastname: Guest
authors.forename: James S
authors.initials: JS
authors.lastname: Harrop
authors.forename: Bizhan
authors.initials: B
authors.lastname: Aarabi
authors.forename: Robert G
authors.initials: RG
authors.lastname: Grossman
authors.forename: James W
authors.initials: JW
authors.lastname: Fawcett
authors.forename: Michael G
authors.initials: MG
authors.lastname: Fehlings
authors.forename: Charles H
authors.initials: CH
authors.lastname: Tator
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D003657:Decision Making; D006801:Humans; D012107:Research Design / Q000592:standards*; D013119:Spinal Cord Injuries / Q000628:therapy*