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

<jats:p>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.</jats:p>

Utilization of multiple-criteria decision analysis (MCDA) to support healthcare decision-making FIFARMA, 2016

“…Diagnosis and treatment decisionsii. Clinical trial designAdunlin et al [16]Guest et al [17]Canadai. Healthcare priority-settingii.…”

The Cancer Drug Tamoxifen: A Potential Therapeutic Treatment for Spinal Cord Injury

“…Based on the criteria outlined in the review by Tator and colleagues 49 and Guest and colleagues, 50 we summarized our results in Table 3, which suggest that TMX may be a promising intervention for the treatment of SCI. For example, TMX readily crosses the blood-brain barrier, [51][52][53] and therefore can be systemically administered, which has a clear clinical advantage.…”

Developing a spinal cord injury research strategy using a structured process of evidence review and stakeholder dialogue. Part II: Background to a research strategy

“…Formation of collaborative networks, such as the Spinal Cord Injury Network, 4 North American Clinical Trials Network, 5,6 NeuroRecovery Network 7 and European Multicentre Study about Spinal Cord Injury; 8 Development of a grading system and other strategies to evaluate the readiness of preclinical studies for clinical translation; 9,10 Development of guidelines for the conduct of SCI clinical trials, such as the International Campaign for Cures of Spinal Cord Injury Paralysis series [11][12][13][14] and for preclinical research, through the United States National Institute of Neurological Disorders and Stroke 15 and, more recently, guidelines for reporting through the Minimum Information about a Spinal Cord Injury experiment project; 16 Development of International SCI core data sets; 17,18 and Development of SCI patient registries, such as the Australian Spinal Cord Injury Register 19 and the Rick Hansen Spinal Cord Injury Registry in Canada, 20 to facilitate research, injury monitoring and benchmarking.…”