TABLE 3-6 Criteria for Determining and Validating a Biomarker Used to Monitor Spinal Cord Injury Progression and Recovery of Function

Necessary properties of a progression marker

  • Describe a biological process that changes with the progression of the disease or recovery

  • Correlate with clinical deterioration

Necessary properties of a progression indicator biomarker measure used as a

  • Objective (i.e., it should be amenable to a blinded or a centralized assessment)

  • Reproducible (i.e., repeat measurements of the progression indicator for the same patient should be highly correlated)

  • Specific to changes in progression indicator; otherwise, the effects of other changes in the biomarker (e.g., compensatory changes related to drugs used to treat the injury or to agent under study in a clinical trial) should be known so that suitable adjustments in the analysis of clinical trial data can be made

  • Low signal-to-noise ratio for the biomarker measure

  • Safe and tolerable and should not require maneuvers that could unblind the study

Other desirable properties of a biomarker measure used as a progression indicator

  • Relatively inexpensive and easy to use

  • Capable of being used in repeated studies with a particular individual with a spinal cord injury

Data needed to support the use of progression indicator or biomarker measurement for application to a clinical trial for study of spinal cord injury

  • Data from longitudinal studies should be available for a sufficient number of individuals with spinal cord injuries to allow an informative assessment of the distributional properties (e.g., mean and variance) of the progression measure progression over periods of time pertinent to future clinical trials; such data are needed to allow calculation of the sample size and power for trials to evaluate the effects of specific treatments on spinal cord injury progression

NOTE: This table is based on recommendations for the development of biomarkers for use in monitoring the progression of Parkinson’s disease.

SOURCE: Adapted from Brooks et al., 2003.

Casha et al., 2001). Thus, identification of specific fluctuations in the levels of proteins like interleukin-6 and Fas could inform clinicians about changes in an individual’s level of injury.

  • Treatment guidance. Analysis of gene expression during the course of the injury and recovery could provide clinicians with detailed informa-

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