RIGOR Guidelines: Escalating STAIR and STEPS for Effective Translational Research

Overview

Journal Transl Stroke Res

Publisher Springer

Date 2013 May 10

PMID 23658596

Citations 167

Authors

Paul A Lapchak

John H Zhang

Linda J Noble-Haeusslein

Affiliations

Soon will be listed here.

Abstract

Stroke continues to be a serious and significant health problem in the USA and worldwide. This article will emphasize the need for good laboratory practices, transparent scientific reporting, and the use of translational research models representative of the disease state to develop effective treatments. This will allow for the testing and development of new innovative strategies so that efficacious therapies can be developed to treat ischemic and hemorrhagic stroke. This article recommends guidelines for effective translational research, most importantly, the need for study blinding, study group randomization, power analysis, accurate statistical analysis, and a conflict of interest statement. Additional guidelines to ensure reproducibility of results and confirmation of efficacy in multiple species are discussed.

Citing Articles

Advice for translational neuroscience: move deliberately and build things.

Hays S, Rennaker R, Kilgard M Bioelectron Med. 2025; 11(1):3.

PMID: 39894794 PMC: 11789403. DOI: 10.1186/s42234-025-00165-w.

Unravelling Secondary Brain Injury: Insights from a Human-Sized Porcine Model of Acute Subdural Haematoma.

Kapapa T, Wernheimer V, Hoffmann A, Merz T, Zink F, Wolfschmitt E Cells. 2025; 14(1.

PMID: 39791718 PMC: 11720468. DOI: 10.3390/cells14010017.

X-ray fluorescence mapping of brain tissue reveals the profound extent of trace element dysregulation in stroke pathophysiology.

Pushie M, Sylvain N, Hou H, Pendleton N, Wang R, Zimmermann L Metallomics. 2024; 16(12).

PMID: 39547935 PMC: 11631071. DOI: 10.1093/mtomcs/mfae054.

Cerebroprotective Effects of the TLR4-Binding DNA Aptamer ApTOLL in a Rat Model of Ischemic Stroke and Thrombectomy Recanalization.

Aliena-Valero A, Hernandez-Jimenez M, Lopez-Morales M, Tamayo-Torres E, Castello-Ruiz M, Pineiro D Pharmaceutics. 2024; 16(6).

PMID: 38931862 PMC: 11206667. DOI: 10.3390/pharmaceutics16060741.

Analysis of animal-to-human translation shows that only 5% of animal-tested therapeutic interventions obtain regulatory approval for human applications.

Ineichen B, Furrer E, Gruninger S, Zurrer W, Macleod M PLoS Biol. 2024; 22(6):e3002667.

PMID: 38870090 PMC: 11175415. DOI: 10.1371/journal.pbio.3002667.

References

Cook D, Tymianski M . Nonhuman primate models of stroke for translational neuroprotection research. Neurotherapeutics. 2012; 9(2):371-9. PMC: 3337022. DOI: 10.1007/s13311-012-0115-z. View

Lees K, Walters M . Acute stroke and diabetes. Cerebrovasc Dis. 2005; 20 Suppl 1:9-14. DOI: 10.1159/000088232. View

Fisher M . Recommendations for advancing development of acute stroke therapies: Stroke Therapy Academic Industry Roundtable 3. Stroke. 2003; 34(6):1539-46. DOI: 10.1161/01.STR.0000072983.64326.53. View

Lapchak P . Neuroprotective and neurotrophic curcuminoids to treat stroke: a translational perspective. Expert Opin Investig Drugs. 2010; 20(1):13-22. DOI: 10.1517/13543784.2011.542410. View

van Gijn J, Kerr R, Rinkel G . Subarachnoid haemorrhage. Lancet. 2007; 369(9558):306-18. DOI: 10.1016/S0140-6736(07)60153-6. View

Pardo Cabello A, Bermudo Conde S, Manzano Gamero V, Gomez Jimenez F, de la Higuera Torres-Puchol J . Implementation of clinical practice guidelines for acute ischaemic stroke in specialist care centres. Neurologia. 2012; 28(3):137-44. DOI: 10.1016/j.nrl.2012.04.008. View

. Stem Cell Therapies as an Emerging Paradigm in Stroke (STEPS): bridging basic and clinical science for cellular and neurogenic factor therapy in treating stroke. Stroke. 2008; 40(2):510-5. DOI: 10.1161/STROKEAHA.108.526863. View

Feuerstein G, Zaleska M, Krams M, Wang X, Day M, Rutkowski J . Missing steps in the STAIR case: a Translational Medicine perspective on the development of NXY-059 for treatment of acute ischemic stroke. J Cereb Blood Flow Metab. 2007; 28(1):217-9. DOI: 10.1038/sj.jcbfm.9600516. View

. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995; 333(24):1581-7. DOI: 10.1056/NEJM199512143332401. View

10.

Turner R, Jickling G, Sharp F . Are Underlying Assumptions of Current Animal Models of Human Stroke Correct: from STAIRs to High Hurdles?. Transl Stroke Res. 2011; 2(2):138-43. PMC: 3085747. DOI: 10.1007/s12975-011-0067-3. View

11.

Bath P, Gray L, Bath A, Buchan A, Miyata T, Green A . Effects of NXY-059 in experimental stroke: an individual animal meta-analysis. Br J Pharmacol. 2009; 157(7):1157-71. PMC: 2743834. DOI: 10.1111/j.1476-5381.2009.00196.x. View

12.

Saver J, Albers G, Dunn B, Johnston K, Fisher M . Stroke Therapy Academic Industry Roundtable (STAIR) recommendations for extended window acute stroke therapy trials. Stroke. 2009; 40(7):2594-600. PMC: 2761073. DOI: 10.1161/STROKEAHA.109.552554. View

13.

Kilkenny C, Browne W, Cuthill I, Emerson M, Altman D . Animal research: reporting in vivo experiments--the ARRIVE guidelines. J Cereb Blood Flow Metab. 2011; 31(4):991-3. PMC: 3070981. DOI: 10.1038/jcbfm.2010.220. View

14.

Fang M, Cutler D, Rosen A . Trends in thrombolytic use for ischemic stroke in the United States. J Hosp Med. 2010; 5(7):406-9. PMC: 3024589. DOI: 10.1002/jhm.689. View

15.

Lyden P, Zivin J . Hemorrhagic transformation after cerebral ischemia: mechanisms and incidence. Cerebrovasc Brain Metab Rev. 1993; 5(1):1-16. View

16.

Ginsberg M . Life after cerovive: a personal perspective on ischemic neuroprotection in the post-NXY-059 era. Stroke. 2007; 38(6):1967-72. DOI: 10.1161/STROKEAHA.106.479170. View

17.

Kilkenny C, Parsons N, Kadyszewski E, Festing M, Cuthill I, Fry D . Survey of the quality of experimental design, statistical analysis and reporting of research using animals. PLoS One. 2009; 4(11):e7824. PMC: 2779358. DOI: 10.1371/journal.pone.0007824. View

18.

Baird T, Parsons M, Barber P, Butcher K, Desmond P, Tress B . The influence of diabetes mellitus and hyperglycaemia on stroke incidence and outcome. J Clin Neurosci. 2003; 9(6):618-26. DOI: 10.1054/jocn.2002.1081. View

19.

Chen J, Chopp M . Neurorestorative treatment of stroke: cell and pharmacological approaches. NeuroRx. 2006; 3(4):466-73. PMC: 2790719. DOI: 10.1016/j.nurx.2006.07.007. View

20.

Moskowitz M, Lo E, Iadecola C . The science of stroke: mechanisms in search of treatments. Neuron. 2010; 67(2):181-98. PMC: 2957363. DOI: 10.1016/j.neuron.2010.07.002. View