PAIN
Volume 139, Issue 2 , Pages 243-247 , 15 October 2008

Animal models and the prediction of efficacy in clinical trials of analgesic drugs: A critical appraisal and call for uniform reporting standards

  • Andrew S.C. Rice

      Affiliations

    • Pain Research, Department of Anaesthetics, Pain Medicine and Intensive Care, Faculty of Medicine, Imperial College London, Chelsea & Westminster Hospital Campus, 369 Fulham Road, London SW10 9NH, UK
    • Corresponding Author InformationCorresponding author. Tel.: +44 (0) 208 746 8816; fax: +44 (0) 208 237 5109.
    • ,
  • Dorothy Cimino-Brown

      Affiliations

    • Mari Lowe Centre for Comparative Oncology Research, School of Veterinary Medicine, University of Pennsylvania, 3900 Delancey Street, Philadelphia, PA 19104-6010, USA
    • ,
  • James C. Eisenach

      Affiliations

    • Department of Anesthesia, Wake Forest University School of Medicine, Medical Center Boulevard, Winston Salem, NC 27157, USA
    • ,
  • Vesa K. Kontinen

      Affiliations

    • Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Central Hospital, Helsinki, Finland
    • ,
  • Michael L. Lacroix-Fralish

      Affiliations

    • Department of Psychology, McGill University, 1205 Dr. Penfield Avenue, Montreal, Que., Canada H3A 1B1
    • ,
  • Ian Machin

      Affiliations

    • Pfizer Global Research and Development, Sandwich CT13 9NJ, UK
    • ,
  • (on behalf of the Preclinical Pain Consortium)
    • ,
  • Jeffrey S. Mogil

      Affiliations

    • Department of Psychology, McGill University, 1205 Dr. Penfield Avenue, Montreal, Que., Canada H3A 1B1
    • ,
  • Thomas Stöhr

      Affiliations

    • Bitop AG, Stockumerstr. 28, 58453 Witten, Germany

Received 27 August 2008 ,Accepted 27 August 2008.

References 

  1. Bebarta V, Luyten D, Heard K. Emergency medicine animal research: does use of randomization and blinding affect the results?. Acad Emerg Med. 2003;10:684–687
  2. Bove G. Mechanical sensory threshold testing using nylon monofilaments: the pain field’s tin standard. Pain. 2006;124:13–17
  3. Boyce S, Hill RG. Discrepant results from preclinical and clinical studies on the potential of substance P-receptor antagonist compounds as analgesics. In:  Devor M,  Rowbotham MC,  Wiesenfeld-Hallin Z editor. Proceedings of the 9th world congress on pain. 16th ed.. Seattle: IASP Press; 2000;p. 313–324
  4. Brown DC, Boston R, Coyne J, Farrar JT. A novel approach to the use of animals in studies of pain: validation of the canine brief pain inventory in canine bone cancer. Pain Med 2008; in press.
  5. Chesler EJ, Wilson SG, Lariviere WR, Rodriguez-Zas SL, Mogil JS. Identification and ranking of genetic and laboratory environment factors influencing a behavioral trait, thermal nociception, via computational analysis of a large data archive. Neurosci Biobehav Rev. 2002;26:907–923
  6. Daniel HC, Narewska J, Serpell M, Hoggart B, Johnson R, Rice AS, et al. Comparison of psychological and physical function in neuropathic pain and nociceptive pain: implications for cognitive behavioral pain management programs. Eur J Pain. 2008;12:731–741
  7. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19
  8. Eisenach JC, Lindner MD. Did experimenter bias conceal the efficacy of spinal opioids in previous studies with the spinal nerve ligation model of neuropathic pain?. Anesthesiology. 2004;100:765–767
  9. Finnerup NB, Otto M, McQuay HJ, Jensen TS, Sindrup SH. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain. 2005;118:289–305
  10. Flatters SJL, Bennett GJ. Ethosuximide reverses paclitaxel- and vincristine-induced painful peripheral neuropathy. Pain. 2004;109:150–161
  11. Fleetwood-Walker SM, Quinn JP, Wallace C, Blackburn-Munro G, Kelly BG, Fiskerstrand CE, et al. Behavioural changes in the rat following infection with varicella zoster virus. J Gen Virol. 1999;80:2433–2436
  12. Fox A, Eastwood C, Gentry C, Manning D, Urban L. Critical evaluation of the streptozotocin model of painful diabetic neuropathy in the rat. Pain. 1999;81:307–316
  13. Garry EM, Delaney A, Anderson HA, Sirinathsinghji EC, Clapp RH, Martin WJ, et al. Varicella zoster virus induces neuropathic changes in rat dorsal root ganglia and behavioral reflex sensitisation that is attenuated by gabapentin or sodium channel blocking drugs. Pain. 2005;118:97–111
  14. Hackam DG. Translating animal research into clinical benefit. BMJ. 2007;334:163–164
  15. Hasnie FS, Breuer J, Parker S, Wallace V, Blackbeard J, Lever I, et al. Further characterization of a rat model of varicella zoster virus-associated pain: relationship between mechanical hypersensitivity and anxiety-related behavior, and the influence of analgesic drugs. Neuroscience. 2007;144:1495–1508
  16. Joseph EK, Chen X, Khasar SG, Levine JD. Novel mechanism of enhanced nociception in a model of AIDS therapy-induced painful peripheral neuropathy in the rat. Pain. 2004;107:147–158
  17. Kontinen VK. Basic science systematic reviews. In:  McQuay HJ,  Kalso E,  Moore RA editor. Systematic reviews in pain research: Methodology refined. 1st ed.. Seattle: IASP Press; 2008;
  18. Kontinen VK, Meert TF. Predictive validity of neuropathic pain models in pharmacological studies with a behavioral outcome in the rat: a systematic review. In:  Dostrovsky JO,  Carr DB,  Koltzenburg M editor. Proceedings of 10th world congress on pain. 24th ed.. Seattle: IASP Press; 2003;p. 489–498
  19. LaBuda CJ, Fuchs PN. Place avoidance paradigm: a simple method for measuring the aversive quality of inflammatory and neuropathic pain in rats. Exp Neurol. 2000;163:490–494
  20. Langford DJ, Crager SE, Shehzad Z, Smith SB, Sotocinal SG, Levenstadt JS, et al. Social modulation of pain as evidence for empathy in mice. Science. 2006;312:1967–1970
  21. Lindner MD, Frydel BR, Francis JM, Cain CK. Analgesic effects of adrenal chromaffin allografts: contingent on special procedures or due to experimenter bias?. J Pain. 2003;4:64–73
  22. Malcangio M, Tomlinson DR. A pharmacologic analysis of mechanical hyperalgesia in streptozocin/diabetic rats. Pain. 1998;76:151–157
  23. Meyer-Rosberg K, Kvarnstrom A, Kinnman E, Gordh T, Nordfors LO, Kristofferson A, et al. Peripheral neuropathic pain – a multidimensional burden for patients. Eur J Pain. 2001;5:379–389
  24. Mignini LE, Khan KS. Methodological quality of systematic reviews of animal studies: a survey of reviews of basic research. BMC Med Res Methodol. 2006;6:10
  25. Mogil JS, Chanda ML. The case for the inclusion of female subjects in basic science studies of pain. Pain. 2005;117:1–5
  26. Mogil JS, Crager SE. What should we be measuring in behavioral studies of chronic pain in animals?. Pain. 2004;112:12–15
  27. Moher D, Schulz F, Altman G, Lepage L. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–1194
  28. Monassi CR, Bandler R, Keay KA. A subpopulation of rats show social and sleep–waking changes typical of chronic neuropathic pain following peripheral nerve injury. Eur J Neurosci. 2003;17:1907–1920
  29. Pedersen LH, Blackburn-Munro G. Pharmacological characterisation of place escape/avoidance behaviour in the rat chronic constriction injury model of neuropathic pain. Psychopharmacology (Berl). 2006;185:208–217
  30. Perel P, Roberts I, Sena E, Wheble P, Briscoe C, Sandercock P, et al. Comparison of treatment effects between animal experiments and clinical trials: systematic review. BMJ. 2007;334:197
  31. Rice ASC, Lever IJ, Zarnegar R. Cannabinoids and analgesia, with special reference to neuropathic pain. In:  McQuay HJ,  Kalso E,  Moore RA editor. Systematic reviews and meta-analyses in pain. Seattle: IASP Press; 2008;p. 233–246
  32. Rice ASC, Maton S Post Herpetic Neuralgia Study Group. Gabapentin in postherpetic neuralgia; a randomised, double-blind, controlled study. Pain. 2001;94:215–224
  33. Roeska K, Doods H, Arndt K, Treede RD, Ceci A. Anxiety-like behaviour in rats with mononeuropathy is reduced by the analgesic drugs morphine and gabapentin. Pain 2008; doi 10.1016/j.pain.2008.05.003.
  34. Rolke R, Baron R, Maier C, Tolle TR, Treede RD, Beyer A, et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006;123:231–243
  35. Schnabel J. Neuroscience: standard model. Nature. 2008;454:682–685
  36. Scott FT, Leedham-Green ME, Barrett-Muir WY, Hawrami K, Gallagher WJ, Johnson R, et al. A study of shingles and the development of postherpetic neuralgia in East London. J Med Virol. 2003;70:S24–S30
  37. Sena E, van der Worp HB, Howells D, Macleod M. How can we improve the pre-clinical development of drugs for stroke?. Trends Neurosci. 2007;30:433–439
  38. Stevenson GW, Bilsky EJ, Negus SS. Targeting pain-suppressed behaviors in preclinical assays of pain and analgesia: effects of morphine on acetic acid-suppressed feeding in C57BL/6J mice. J Pain. 2006;7:408–416
  39. Wallace VCJ, Blackbeard J, Segerdahl A, Hasnie FS, Pheby T, McMahon SB, et al. Characterisation of rodent models of HIV-gp120 and anti-retroviral associated neuropathic pain. Brain. 2007;130:2688–2702
  40. Wallace VCJ, Blackbeard J, Pheby T, Segerdahl AR, Davies M, Hasnie F, et al. Pharmacological, behavioural and mechanistic analysis of HIV-1 gp120 induced painful neuropathy. Pain. 2007;133:47–63
  41. Whiteside GT, Adedoyin A, Leventhal L. Predictive validity of animal pain models? A comparison of the pharmacokinetic-pharmacodynamic relationship for pain drugs in rats and humans. Neuropharmacology. 2008;54:767–775

PII: S0304-3959(08)00508-3

doi: 10.1016/j.pain.2008.08.017

PAIN
Volume 139, Issue 2 , Pages 243-247 , 15 October 2008

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