Biomarkers and Surrogate End points in Multiple Sclerosis Trials: Regulatory Issues.
Publication
, Journal Article
Skeen, MB; Pani, L
Published in: J Clin Neurophysiol
May 1, 2021
Evoked potentials have assisted in the diagnosis of multiple sclerosis for years, but the potential to demonstrate pathophysiologic change has prompted a reconsideration of their potential role as outcome measures in clinical trials of multiple sclerosis. The use of any surrogate end point or biomarker in clinical trials requires a thorough understanding of that end point's performance characteristics and utility in a particular setting. This article explores regulatory issues regarding the use of biomarkers and surrogate end points in clinical trials of multiple sclerosis with particular emphasis on challenges faced by evoked potential studies.
Duke Scholars
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Published In
J Clin Neurophysiol
DOI
EISSN
1537-1603
Publication Date
May 1, 2021
Volume
38
Issue
3
Start / End Page
181 / 185
Location
United States
Related Subject Headings
- Treatment Outcome
- Neurology & Neurosurgery
- Multiple Sclerosis
- Humans
- Evoked Potentials
- Clinical Trials as Topic
- Biomarkers
- 5203 Clinical and health psychology
- 5202 Biological psychology
- 3209 Neurosciences
Citation
APA
Chicago
ICMJE
MLA
NLM
Skeen, M. B., & Pani, L. (2021). Biomarkers and Surrogate End points in Multiple Sclerosis Trials: Regulatory Issues. J Clin Neurophysiol, 38(3), 181–185. https://doi.org/10.1097/WNP.0000000000000732
Skeen, Mark B., and Luca Pani. “Biomarkers and Surrogate End points in Multiple Sclerosis Trials: Regulatory Issues.” J Clin Neurophysiol 38, no. 3 (May 1, 2021): 181–85. https://doi.org/10.1097/WNP.0000000000000732.
Skeen MB, Pani L. Biomarkers and Surrogate End points in Multiple Sclerosis Trials: Regulatory Issues. J Clin Neurophysiol. 2021 May 1;38(3):181–5.
Skeen, Mark B., and Luca Pani. “Biomarkers and Surrogate End points in Multiple Sclerosis Trials: Regulatory Issues.” J Clin Neurophysiol, vol. 38, no. 3, May 2021, pp. 181–85. Pubmed, doi:10.1097/WNP.0000000000000732.
Skeen MB, Pani L. Biomarkers and Surrogate End points in Multiple Sclerosis Trials: Regulatory Issues. J Clin Neurophysiol. 2021 May 1;38(3):181–185.
Published In
J Clin Neurophysiol
DOI
EISSN
1537-1603
Publication Date
May 1, 2021
Volume
38
Issue
3
Start / End Page
181 / 185
Location
United States
Related Subject Headings
- Treatment Outcome
- Neurology & Neurosurgery
- Multiple Sclerosis
- Humans
- Evoked Potentials
- Clinical Trials as Topic
- Biomarkers
- 5203 Clinical and health psychology
- 5202 Biological psychology
- 3209 Neurosciences