Biomarkers and surrogate markers: An FDA perspective

@article{Katz2004BiomarkersAS,
  title={Biomarkers and surrogate markers: An FDA perspective},
  author={Russell L Katz},
  journal={NeuroRX},
  year={2004},
  volume={1},
  pages={189-195}
}
Interest is increasing rapidly in the use of surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials. Many such surrogate markers have been proposed as potential candidates for use in definitive effectiveness trials of agents to treat neurologic or psychiatric disease, but as of this date, there are no such markers that have been adequately “validated,” that is, shown to predict the effect of the treatment on the clinical outcome of interest… CONTINUE READING
BETA

Similar Papers

Topics from this paper.

Citations

Publications citing this paper.
SHOWING 1-10 OF 143 CITATIONS, ESTIMATED 41% COVERAGE

EEG beta 2 power as surrogate marker for memory impairment: a pilot study.

  • International psychogeriatrics
  • 2017
VIEW 3 EXCERPTS
CITES BACKGROUND
HIGHLY INFLUENCED

Quantifying Disease Progression in Amyotrophic Lateral Sclerosis

  • Annals of neurology
  • 2014
VIEW 14 EXCERPTS
CITES BACKGROUND
HIGHLY INFLUENCED

Prediction of cognitive decline by positron emission tomography of brain amyloid and tau.

  • Archives of neurology
  • 2012
VIEW 6 EXCERPTS
CITES BACKGROUND
HIGHLY INFLUENCED

FILTER CITATIONS BY YEAR

2005
2019

CITATION STATISTICS

  • 6 Highly Influenced Citations

  • Averaged 11 Citations per year from 2017 through 2019

References

Publications referenced by this paper.
SHOWING 1-10 OF 13 REFERENCES

End points and United States Food and Drug Administration approval of oncology drugs.

  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2003
VIEW 1 EXCERPT

Evaluating surrogate endpoints.

  • Controlled clinical trials
  • 2002
VIEW 1 EXCERPT

Research Institute of the Alzheimer’s Association and the National Institute on Aging Working Group. Consensus report of the Working Group on: molecular and biochemical markers of Alzheimer’s disease

The Ronald, Nancy Reagan
  • Neurobiol Aging
  • 1998

Slowing the progression of Alzheimer disease: methodologic issues.

  • Alzheimer disease and associated disorders
  • 1997
VIEW 1 EXCERPT