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.
  
  
  
  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.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Ralf
authors.initials: R
authors.lastname: Baron
authors.forename: Michael
authors.initials: M
authors.lastname: Polydefkis
authors.forename: Irene
authors.initials: I
authors.lastname: Tracey
authors.forename: David
authors.initials: D
authors.lastname: Borsook
authors.forename: Robert R
authors.initials: RR
authors.lastname: Edwards
authors.forename: Richard E
authors.initials: RE
authors.lastname: Harris
authors.forename: Tor D
authors.initials: TD
authors.lastname: Wager
authors.forename: Lars
authors.initials: L
authors.lastname: Arendt-Nielsen
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Carr
authors.forename: Amy
authors.initials: A
authors.lastname: Chappell
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.forename: Roy
authors.initials: R
authors.lastname: Freeman
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.forename: Veeraindar
authors.initials: V
authors.lastname: Goli
authors.forename: Juergen
authors.initials: J
authors.lastname: Haeussler
authors.forename: Troels
authors.initials: T
authors.lastname: Jensen
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Kent
authors.forename: Ernest A
authors.initials: EA
authors.lastname: Kopecky
authors.forename: David A
authors.initials: DA
authors.lastname: Lee
authors.forename: William
authors.initials: W
authors.lastname: Maixner
authors.forename: John D
authors.initials: JD
authors.lastname: Markman
authors.forename: Justin C
authors.initials: JC
authors.lastname: McArthur
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Lav
authors.initials: L
authors.lastname: Parvathenani
authors.forename: Srinivasa N
authors.initials: SN
authors.lastname: Raja
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Andrew S C
authors.initials: ASC
authors.lastname: Rice
authors.forename: Michael C
authors.initials: MC
authors.lastname: Rowbotham
authors.forename: Jeffrey K
authors.initials: JK
authors.lastname: Tobias
authors.forename: Ajay D
authors.initials: AD
authors.lastname: Wasan
authors.forename: James
authors.initials: J
authors.lastname: Witter
mesh_terms: D015415:Biomarkers; D001921:Brain / Q000000981:diagnostic imaging / Q000503:physiopathology; D059350:Chronic Pain / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology / Q000503:physiopathology; D006801:Humans; D012684:Sensory Thresholds / Q000502:physiology*; D012867:Skin / Q000473:pathology
chemical_list: D015415:Biomarkers
keywords: Biomarkers; IMMPACT; brain imaging; sensory testing; skin punch biopsy