Description
The MSRP Metric Development and Validation Award is being offered for the first time in FY09. The Metric Development and Validation Award is designed to develop and/or validate readily accessible, cost-effective, analytical methods that may be utilized to quantify the disease, monitor disease progress, and/or evaluate the efficacy of disease therapies. Particular emphasis is laid on the development of measurement processes with regard to reproducibility and accuracy and/or the validation of existing and novel measures. Resulting metrics should have broad clinical and/or research applications, as well as the potential for high impact on the MS clinical and/or research community. FY09 DOD Multiple Sclerosis Metric Development and Validation Award 3 Clinical trials are not allowed under this mechanism. Refer to the Application Instructions and General Information, Appendix 6, for additional information on clinical trials. The overall goal of this award is to accelerate advances in MS research. The following are significant features of this award mechanism: 1. Impact: High-impact measurements, if successful, will significantly improve the sensitivity and/or specificity of current methods, or provide methods specific to novel targets, and thereby will enable improved experiments toward the MSRP vision of preventing the occurrence, reversing or slowing the progression and disability, and lessening the impact of MS. Proposals should address a central critical problem or question in MS research. Examples include, but are not limited to, the development of: Metrics for prognosis and/or progression monitoring within individual patients Disease activity or severity metrics for use in longitudinal studies of MS Novel methods for integrating and validating existing data sets Metrics targeting specific subgroups within the MS population (e.g., ethnicity) Quick and inexpensive function-specific measures of physical or cognitive abilities before and after a quantifiable work load 2. Clinical/Research Metrics: It is critical that each proposal address at least one area of MS research in which current measures are inadequate for clinical and/or research needs. Examples of metrics that if systematically validated would be of interest for MS detection and quantification include, but are not limited to: Biometrics: Biomarkers of central nervous system (CNS) autoimmunity, demyelination, axonal degeneration, synaptic regeneration, microbial exposure, nutritional status, gene expression, epigenetics, genetic susceptibility, etc. Cognitive Disability Metrics: Memory attention, visual perception, information processing speed, executive function, etc. Imaging Metrics: Magnetic resonance imaging, optical coherence tomography, positron emission tomography, etc. Multidimensional Metrics: Algorithms using combinations of multiple metrics Physical Disability Metrics: Ease of movement, strength, speed, coordination, dexterity, use of assistive devices, etc. Quality of Life Metrics: Pain, fatigue, sleep disorder, depression, anger, sexual dysfunction, co-morbidities, etc. 3. Preliminary Data: Submission of preliminary data relevant to MS and the proposed project is encouraged but not required. If preliminary data is provided, it must have been generated from the laboratory of the Principal Investigator (PI) or collaborators listed on this award application. Although groundbreaking research often involves a degree of risk due to unforeseen difficulties or results, proposals should be based on a sound scientific rationale FY09 DOD Multiple Sclerosis Metric Development and Validation Award 4 that is established through logical reasoning and/or critical review and analysis of the literature.