The potential role of sensory testing, skin biopsy, and

J Pain · Jul 2017

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The potential role of sensory testing, skin biopsy, and functional brain imaging as biomarkers in chronic pain clinical trials: IMMPACT considerations.

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. ⋯ 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.

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- 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 N Raja, Bob A Rappaport, RiceAndrew S CASC, Michael C Rowbotham, Jeffrey K Tobias, Ajay D Wasan, and James Witter.
- J Pain. 2017 Jul 1; 18 (7): 757777757-777.
UnlabelledValid 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.PerspectiveThe 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.Copyright © 2017 American Pain Society. All rights reserved.

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The potential role of sensory testing, skin biopsy, and functional brain imaging as biomarkers in chronic pain clinical trials: IMMPACT considerations.

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