Can Animal Models of Disease Reliably Inform Human Studies?

1. HackamDG

RedelmeierDA

2006 Translation of research evidence from animals to humans. JAMA 296 1731 1732

2. PerelP

RobertsI

SenaE

WhebleP

BriscoeC

2007 Comparison of treatment effects between animal experiments and clinical trials: systematic review. B M J 334 197

3. HackamDG

2007 Translating animal research into clinical benefit. B M J 334 163 164

4. BesselinkMG

van SantvoortHC

BuskensE

BoermeesterMA

van GoorH

2008 Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet 371 651 659

5. ShuaibA

LeesKR

LydenP

GrottaJ

DavalosA

2007 NXY-059 for the treatment of acute ischemic stroke. N Engl J Med 357 562 571

6. DirksenMT

LaarmanGJ

SimoonsML

DunckerDJ

2007 Reperfusion injury in humans: a review of clinical trials on reperfusion injury inhibitory strategies. Cardiovasc Res 74 343 355

7. YellonDM

HausenloyDJ

2007 Myocardial reperfusion injury. N Engl J Med 357 1121 1135

8. O'CollinsVE

MacleodMR

DonnanGA

HorkyLL

van der WorpBH

2006 1,026 experimental treatments in acute stroke. Ann Neurol 59 467 477

9. Van der WorpHB

Van GijnJ

2007 Clinical practice. Acute ischemic stroke. N Engl J Med 357 572 579

10. GrottaJ

2001 Neuroprotection is unlikely to be effective in humans using current trial designs. Stroke 33 306 307

11. GladstoneDJ

BlackSE

HakimAM

Heart and Stroke Foundation of Ontario Centre of Excellence in Stroke Recovery 2002 Toward wisdom from failure. Lessons from neuroprotective stroke trials and new therapeutic directions. Stroke 33 2123 2136

12. JuniP

AltmanDG

EggerM

2001 Systematic reviews in health care: Assessing the quality of controlled clinical trials. B M J 323 42 46

13. AltmanDG

SchulzKF

MoherD

EggerM

DavidoffF

2001 The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134 663 694

14. Stroke Therapy Academic Industry Roundtable (STAIR) 1999 Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke 30 2752 2758

15. DirnaglU

2006 Bench to bedside: the quest for quality in experimental stroke research. J Cereb Blood Flow Metab 26 1465 1478

16. SenaE

Van der WorpHB

HowellsD

MacleodM

2007 How can we improve the pre-clinical development of drugs for stroke? Trends Neurosci 30 433 439

17. MacleodMR

FisherM

O'CollinsV

SenaES

DirnaglU

2009 Good laboratory practice: preventing introduction of bias at the bench. Stroke 40 e50 e52

18. RosenthalR

1966 Experimenter effects in behavioral research. New York Appleton-Century-Crofts

19. Van der WorpHB

de HaanP

MorremaE

KalkmanCJ

2005 Methodological quality of animal studies on neuroprotection in focal cerebral ischaemia. J Neurol 252 1108 1114

20. Van der WorpHB

SenaES

DonnanGA

HowellsDW

MacleodMR

2007 Hypothermia in animal models of acute ischaemic stroke: a systematic review and meta-analysis. Brain 130 3063 3074

21. CampbellMJ

JuliousSA

AltmanDG

1995 Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. B M J 311 1145 1148

22. FestingMF

AltmanDG

2002 Guidelines for the design and statistical analysis of experiments using laboratory animals. ILAR J 43 244 258

23. BathPM

MacleodMR

GreenAR

2009 Emulating multicentre clinical stroke trials: a new paradigm for studying novel interventions in experimental models of stroke. Int J Stroke 4 471 479

24. LeeDS

NguyenQT

LapointeN

AustinPC

OhlssonA

2003 Meta-analysis of the effects of endothelin receptor blockade on survival in experimental heart failure. J Card Fail 9 368 374

25. MacleodMR

Van der WorpHB

SenaES

HowellsDW

DirnaglU

2008 Evidence for the efficacy of NXY-059 in experimental focal cerebral ischaemia is confounded by study quality. Stroke 39 2824 2829

26. SamaranayakeS

2009 Study Quality in Experimental Stroke. Camarades Monograph Number 2, http://www.camarades.info/index_files/CM2.pdf. (accessed 22/12/09)

27. MiettinenOS

1983 The need for randomisation in the study of intended effects. Stat Med 2 267 271

28. SchulzKF

ChalmersI

HayesRJ

AltmanDG

1995 Emperical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273 408 412

29. NoseworthyJH

ebersGC

VandervoortMK

FarquharRE

YetisirE

1994 The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology 44 16 20

30. SchulzKF

GrimesDA

2002 Blinding in randomised trials: hiding who got what. Lancet 359 696 700

31. SchulzKF

GrimesDA

2002 Allocation concealment in randomised trials: defending against deciphering. Lancet 359 614 618

32. SchulzKF

GrimesDA

2005 Sample size calculations in randomised trials: mandatory and mystical. Lancet 365 1348 1353

33. BebartaV

LuytenD

HeardK

2003 Emergency medicine animal research: Does use of randomization and blinding affect the results? Acad Emerg Med 10 684 687

34. MacleodMR

O'CollinsT

HowellsDW

DonnanGA

2004 Pooling of animal experimental data reveals influence of study design and publication bias. Stroke 35 1203 1208

35. CrossleyNA

SenaE

GoehlerJ

HornJ

van derWB

2008 Empirical evidence of bias in the design of experimental stroke studies: a metaepidemiologic approach. Stroke 39 929 934

36. Van der WorpHB

RaaijmakersTW

KappelleLJ

2008 Early complications of ischemic stroke. Curr Treat Options Neurol 10 440 449

37. SaverJL

JohnstonKC

HomerD

WitykR

KoroshetzW

1999 Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials. Stroke 30 293 298

38. The National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Study Group 2000 Effect of intravenous recombinant tissue plasminogen activator on ischemic stroke lesion size measured by computed tomography. Stroke 31 2912 2919

39. KimmelmanJ

LondonAJ

RavinaB

RamsayT

BernsteinM

2009 Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations. Mov Disord 24 1893 1901

40. ScottS

KranzJE

ColeJ

LincecumJM

ThompsonK

2008 Design, power, and interpretation of studies in the standard murine model of ALS. Amyotroph Lateral Scler 9 4 15

41. DwanK

AltmanDG

ArnaizJA

BloomJ

ChanAW

2008 Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 3 e3081

42. DirxMJ

ZeegersMP

DagneliePC

van den BogaardT

van den BrandtPA

2003 Energy restriction and the risk of spontaneous mammary tumors in mice: a meta-analysis. Int J Cancer 106 766 770

43. MacleodMR

O'CollinsT

HorkyLL

HowellsDW

DonnanGA

2005 Systematic review and metaanalysis of the efficacy of FK506 in experimental stroke. J Cereb Blood Flow Metab 25 713 721

44. JuutilainenJ

KumlinT

NaaralaJ

2006 Do extremely low frequency magnetic fields enhance the effects of environmental carcinogens? A meta-analysis of experimental studies. Int J Radiat Biol 82 1 12

45. BenatarM

2007 Lost in translation: treatment trials in the SOD1 mouse and in human ALS. Neurobiol Dis 26 1 13

46. NeitzkeU

HarderT

SchellongK

MelchiorK

ZiskaT

2008 Intrauterine growth restriction in a rodent model and developmental programming of the metabolic syndrome: a critical appraisal of the experimental evidence. Placenta 29 246 254

47. SenaES

Van der WorpHB

BathPMW

HowellsDW

MacleodMR

2010 Publication bias in reports of animal stroke studies leads to major overstatement of efficacy. PloS Biology. PLoS Biol 8(3) e1000344 doi:10.1371/journal. pbio.1000344

48. De AngelisC

DrazenJM

FrizelleFA

HaugC

HoeyJ

2004 Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 351 1250 1251

49. WillmotM

GibsonC

GrayL

MurphyS

BathP

2005 Nitric oxide synthase inhibitors in experimental ischemic stroke and their effects on infarct size and cerebral blood flow: a systematic review. Free Radic Biol Med 39 412 425

50. WillmotM

GrayL

GibsonC

MurphyS

BathPM

2005 A systematic review of nitric oxide donors and L-arginine in experimental stroke; effects on infarct size and cerebral blood flow. Nitric Oxide 12 141 149

51. GibsonCL

GrayLJ

MurphySP

BathPM

2006 Estrogens and experimental ischemic stroke: a systematic review. J Cereb Blood Flow Metab 26 1103 1113

52. GibsonCL

GrayLJ

BathPM

MurphySP

2008 Progesterone for the treatment of experimental brain injury; a systematic review. Brain 131 318 328

53. BanwellV

SenaES

MacleodMR

2009 Systematic review and stratified meta-analysis of the efficacy of interleukin-1 receptor antagonist in animal models of stroke. J Stroke Cerebrovasc Dis 18 269 276