The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations

Shannon M. Smith; Robert H. Dworkin; Dennis C. Turk; Ralf Baron; Michael Polydefkis; Irene Tracey; David Borsook; Robert R. Edwards; Richard E. Harris; Tor D. Wager; Lars Arendt-Nielsen; Laurie B. Burke; Daniel B. Carr; Amy Chappell; John T. Farrar; Roy Freeman; Ian Gilron; Veeraindar Goli; Juergen Haeussler; Troels Jensen; Nathaniel P. Katz; Jeffrey Kent; Ernest A. Kopecky; David A. Lee; William Maixner; John D. Markman; Justin C. McArthur; Michael P. McDermott; Lav Parvathenani; Srinivasa Naga Raja; Bob A. Rappaport; Andrew S.C. Rice; Michael C. Rowbotham; Jeffrey K. Tobias; Ajay D. Wasan; James Witter

doi:10.1016/j.jpain.2017.02.429

The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations

Shannon M. Smith, Robert H. Dworkin, Dennis C. Turk, Ralf Baron, Michael Polydefkis, Irene Tracey, David Borsook, Robert R. Edwards, Richard E. Harris, Tor D. Wager, Lars Arendt-Nielsen, Laurie B. Burke, Daniel B. Carr, Amy Chappell, John T. Farrar, Roy Freeman, Ian Gilron, Veeraindar Goli, Juergen Haeussler, Troels JensenNathaniel P. Katz, Jeffrey Kent, Ernest A. Kopecky, David A. Lee, William Maixner, John D. Markman, Justin C. McArthur, Michael P. McDermott, Lav Parvathenani, Srinivasa Naga Raja, Bob A. Rappaport, Andrew S.C. Rice, Michael C. Rowbotham, Jeffrey K. Tobias, Ajay D. Wasan, James Witter

School of Medicine

Research output: Contribution to journal › Review article › peer-review

47 Scopus citations

Abstract

Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. Perspective The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability.

Original language	English (US)
Pages (from-to)	757-777
Number of pages	21
Journal	Journal of Pain
Volume	18
Issue number	7
DOIs	https://doi.org/10.1016/j.jpain.2017.02.429
State	Published - Jul 2017

Keywords

Biomarkers
IMMPACT
brain imaging
sensory testing
skin punch biopsy

ASJC Scopus subject areas

Neurology
Clinical Neurology
Anesthesiology and Pain Medicine

Access to Document

10.1016/j.jpain.2017.02.429

Cite this

Smith, S. M., Dworkin, R. H., Turk, D. C., Baron, R., Polydefkis, M., Tracey, I., Borsook, D., Edwards, R. R., Harris, R. E., Wager, T. D., Arendt-Nielsen, L., Burke, L. B., Carr, D. B., Chappell, A., Farrar, J. T., Freeman, R., Gilron, I., Goli, V., Haeussler, J., ... Witter, J. (2017). The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations. Journal of Pain, 18(7), 757-777. https://doi.org/10.1016/j.jpain.2017.02.429

Smith, SM, Dworkin, RH, Turk, DC, Baron, R, Polydefkis, M, Tracey, I, Borsook, D, Edwards, RR, Harris, RE, Wager, TD, Arendt-Nielsen, L, Burke, LB, Carr, DB, Chappell, A, Farrar, JT, Freeman, R, Gilron, I, Goli, V, Haeussler, J, Jensen, T, Katz, NP, Kent, J, Kopecky, EA, Lee, DA, Maixner, W, Markman, JD, McArthur, JC, McDermott, MP, Parvathenani, L, Raja, SN, Rappaport, BA, Rice, ASC, Rowbotham, MC, Tobias, JK, Wasan, AD & Witter, J 2017, 'The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations', Journal of Pain, vol. 18, no. 7, pp. 757-777. https://doi.org/10.1016/j.jpain.2017.02.429

@article{00d6233d3ce34e179dab2912f87770fe,

title = "The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations",

abstract = "Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. Perspective The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability.",

keywords = "Biomarkers, IMMPACT, brain imaging, sensory testing, skin punch biopsy",

author = "Smith, {Shannon M.} and Dworkin, {Robert H.} and Turk, {Dennis C.} and Ralf Baron and Michael Polydefkis and Irene Tracey and David Borsook and Edwards, {Robert R.} and Harris, {Richard E.} and Wager, {Tor D.} and Lars Arendt-Nielsen and Burke, {Laurie B.} and Carr, {Daniel B.} and Amy Chappell and Farrar, {John T.} and Roy Freeman and Ian Gilron and Veeraindar Goli and Juergen Haeussler and Troels Jensen and Katz, {Nathaniel P.} and Jeffrey Kent and Kopecky, {Ernest A.} and Lee, {David A.} and William Maixner and Markman, {John D.} and McArthur, {Justin C.} and McDermott, {Michael P.} and Lav Parvathenani and Raja, {Srinivasa Naga} and Rappaport, {Bob A.} and Rice, {Andrew S.C.} and Rowbotham, {Michael C.} and Tobias, {Jeffrey K.} and Wasan, {Ajay D.} and James Witter",

note = "Publisher Copyright: {\textcopyright} 2017 American Pain Society",

year = "2017",

month = jul,

doi = "10.1016/j.jpain.2017.02.429",

language = "English (US)",

volume = "18",

pages = "757--777",

journal = "Journal of Pain",

issn = "1526-5900",

publisher = "Churchill Livingstone",

number = "7",

}

TY - JOUR

T1 - The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials

T2 - IMMPACT Considerations

AU - Smith, Shannon M.

AU - Dworkin, Robert H.

AU - Turk, Dennis C.

AU - Baron, Ralf

AU - Polydefkis, Michael

AU - Tracey, Irene

AU - Borsook, David

AU - Edwards, Robert R.

AU - Harris, Richard E.

AU - Wager, Tor D.

AU - Arendt-Nielsen, Lars

AU - Burke, Laurie B.

AU - Carr, Daniel B.

AU - Chappell, Amy

AU - Farrar, John T.

AU - Freeman, Roy

AU - Gilron, Ian

AU - Goli, Veeraindar

AU - Haeussler, Juergen

AU - Jensen, Troels

AU - Katz, Nathaniel P.

AU - Kent, Jeffrey

AU - Kopecky, Ernest A.

AU - Lee, David A.

AU - Maixner, William

AU - Markman, John D.

AU - McArthur, Justin C.

AU - McDermott, Michael P.

AU - Parvathenani, Lav

AU - Raja, Srinivasa Naga

AU - Rappaport, Bob A.

AU - Rice, Andrew S.C.

AU - Rowbotham, Michael C.

AU - Tobias, Jeffrey K.

AU - Wasan, Ajay D.

AU - Witter, James

PY - 2017/7

Y1 - 2017/7

N2 - Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. Perspective The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability.

AB - Valid and reliable biomarkers can play an important role in clinical trials as indicators of biological or pathogenic processes or as a signal of treatment response. Currently, there are no biomarkers for pain qualified by the U.S. Food and Drug Administration or the European Medicines Agency for use in clinical trials. This article summarizes an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting in which 3 potential biomarkers were discussed for use in the development of analgesic treatments: 1) sensory testing, 2) skin punch biopsy, and 3) brain imaging. The empirical evidence supporting the use of these tests is described within the context of the 4 categories of biomarkers: 1) diagnostic, 2) prognostic, 3) predictive, and 4) pharmacodynamic. Although sensory testing, skin punch biopsy, and brain imaging are promising tools for pain in clinical trials, additional evidence is needed to further support and standardize these tests for use as biomarkers in pain clinical trials. Perspective The applicability of sensory testing, skin biopsy, and brain imaging as diagnostic, prognostic, predictive, and pharmacodynamic biomarkers for use in analgesic treatment trials is considered. Evidence in support of their use and outlining problems is presented, as well as a call for further standardization and demonstrations of validity and reliability.

KW - Biomarkers

KW - IMMPACT

KW - brain imaging

KW - sensory testing

KW - skin punch biopsy

UR - http://www.scopus.com/inward/record.url?scp=85017357343&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85017357343&partnerID=8YFLogxK

U2 - 10.1016/j.jpain.2017.02.429

DO - 10.1016/j.jpain.2017.02.429

M3 - Review article

C2 - 28254585

AN - SCOPUS:85017357343

SN - 1526-5900

VL - 18

SP - 757

EP - 777

JO - Journal of Pain

JF - Journal of Pain

IS - 7

ER -

The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this