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

• Published in: The journal of pain Vol. 18; no. 7; pp. 757 - 777
• Main Authors: Smith, Shannon M, Dworkin, Robert H, Turk, Dennis C, Baron, Ralf, Polydefkis, Michael, Tracey, Irene, Borsook, David, Edwards, Robert R, Harris, Richard E, Wager, Tor D, Arendt-Nielsen, Lars, Burke, Laurie B, Carr, Daniel B, Chappell, Amy, Farrar, John T, Freeman, Roy, Gilron, Ian, Goli, Veeraindar, Haeussler, Juergen, Jensen, Troels, Katz, Nathaniel P, Kent, Jeffrey, Kopecky, Ernest A, Lee, David A, Maixner, William, Markman, John D, McArthur, Justin C, McDermott, Michael P, Parvathenani, Lav, Raja, Srinivasa N, Rappaport, Bob A, Rice, Andrew S.C, Rowbotham, Michael C, Tobias, Jeffrey K, Wasan, Ajay D, Witter, James
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2017
• Subjects: Anesthesia & Perioperative Care; Biomarkers; Brain - diagnostic imaging; Brain - physiopathology; brain imaging; Chronic Pain - diagnosis; Chronic Pain - diagnostic imaging; Chronic Pain - pathology; Chronic Pain - physiopathology; Humans; IMMPACT; Pain Medicine; sensory testing; Sensory Thresholds - physiology; Skin - pathology; skin punch biopsy; brain imaging; Biomarkers; sensory testing; IMMPACT; skin punch biopsy
• ISSN: 1526-5900; 1528-8447; 1528-8447
• DOI: 10.1016/j.jpain.2017.02.429

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.