Abstract
Important questions regarding the conduct of scientific research and data transparency have been raised in various scientific forums over the last 10 years. It is becoming clear, that in spite of published RIGOR guidelines, that improvement in the transparency of scientific research is required to focus on the discovery and drug development process so that a treatment can be provided to stroke patients. We have the unique privilege of conducting research using animal models of a disease so that we can address the development of a new therapy, and we should do this with great care and vigilance. This document identifies valuable resources for researchers to become Good Laboratory Practices compliant and increase and improve data transparency and provides guidelines for accurate data management to continue to propel the translational stroke research field forward while recognizing that there is a shortage of research funds worldwide. While data audits are being considered worldwide by funding agencies and they are used extensively by industry, they are still quite controversial for basic researchers. Due to the special exploratory nature of basic and translational science research, the current challenging funding environment, and independent and individualized laboratory activities, it is debatable if current individualized non-standardized data management and monitoring represents the best approach. Thus, herein, we propose steps to prepare research study data in an acceptable form for archival purposes so that standards for translational research data can be comparable to those that are accepted and adhered to by the clinical community. If all translational research laboratories follow and institute the guidelines while conducting translational research, data from all sources may be more comparable and reliable.
Similar content being viewed by others
References
Lapchak PA, Zhang JH. The high cost of stroke and stroke cytoprotection research. Translational Stroke Research. 2017; doi:10.1007/s12975-016-0518-y.
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, et al. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017; doi:10.1161/CIR.0000000000000485.
Dirnagl U, Macleod MR. Stroke research at a road block: the streets from adversity should be paved with meta-analysis and good laboratory practice. Br J Pharmacol. 2009;157(7):1154–6.
Macleod MR, Fisher M, O'Collins V, Sena ES, Dirnagl U, Bath PM, et al. Good laboratory practice: preventing introduction of bias at the bench. Stroke. 2009;40(3):e50–2.
Jolkkonen J, Kwakkel G. Translational hurdles in stroke recovery studies. Transl Stroke Res. 2016;7(4):331–42.
Napoli E, Borlongan CV. Recent advances in stem cell-based therapeutics for stroke. Transl Stroke Res. 2016;7(6):452–7.
Rodriguez-Frutos B, Otero-Ortega L, Gutierrez-Fernandez M, Fuentes B, Ramos-Cejudo J, Diez-Tejedor E. Stem cell therapy and administration routes after stroke. Transl Stroke Res. 2016;7(5):378–87.
Koh SH, Park HH. Neurogenesis in stroke recovery. Transl Stroke Res. 2016.
Linfante I, Cipolla MJ. Improving reperfusion therapies in the era of mechanical thrombectomy. Transl Stroke Res. 2016;7(4):294–302.
Lapchak PA. Critical early thrombolytic and endovascular reperfusion therapy for acute ischemic stroke victims: a call for adjunct neuroprotection. Transl Stroke Res. 2015;6(5):345–54.
Marbacher S. Animal models for the study of subarachnoid hemorrhage: are we moving towards increased standardization? Transl Stroke Res. 2016;7(1):1–2.
Shi Y, Leak RK, Keep RF, Chen J. Translational stroke research on blood-brain barrier damage: challenges, perspectives, and goals. Transl Stroke Res. 2016;7(2):89–92.
Yang Y, Kimura-Ohba S, Thompson J, Rosenberg GA. Rodent models of vascular cognitive impairment. Transl Stroke Res. 2016;7(5):407–14.
Lapchak PA. A cost-effective rabbit embolic stroke bioassay: insight into the development of acute ischemic stroke therapy. Transl Stroke Res. 2015;6(2):99–103.
Ahnstedt H, McCullough LD, Cipolla MJ. The importance of considering sex differences in translational stroke research. Transl Stroke Res. 2016;7(4):261–73.
Ergul A, Hafez S, Fouda A, Fagan SC. Impact of comorbidities on acute injury and recovery in preclinical stroke research: focus on hypertension and diabetes. Transl Stroke Res. 2016;7(4):248–60.
Guo D, Wilkinson DA, Thompson BG, Pandey AS, Keep RF, Xi G, et al. MRI characterization in the acute phase of experimental subarachnoid hemorrhage. Transl Stroke Res. 2016.
Muir KW, Macrae IM. Neuroimaging as a selection tool and endpoint in clinical and pre-clinical trials. Transl Stroke Res. 2016;7(5):368–77.
Landis SC, Amara SG, Asadullah K, Austin CP, Blumenstein R, Bradley EW, et al. A call for transparent reporting to optimize the predictive value of preclinical research. Nature. 2012;490(7419):187–91.
Lapchak PA. Recommendations and practices to optimize stroke therapy: developing effective translational research programs. Stroke. 2013;44(3):841–3.
Lapchak PA, Zhang JH, Noble-Haeusslein LJ. RIGOR guidelines: escalating STAIR and STEPS for effective translational research. Transl Stroke Res. 2013;4(3):279–85.
Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke. 1999;30(12):2752–8.
Lapchak PA. Scientific rigor recommendations for optimizing the clinical applicability of translational research. J Neurol Neurophysiol. 2012;3:e111.
Axiak Flammer SM, Trim CM. ARRIVE and CONSORT guidelines: do they have a place in veterinary anaesthesia and analgesia? Vet Anaesth Analg. 2016;43(1):2–4.
Blomme EA. The ARRIVE guidelines: a resource for authors and reviewers to ensure that submissions to The Veterinary Journal meet minimal expectations of completeness, accuracy and transparency. Vet J. 2011;189(3):237–8.
Danos O, Davies K, Lehn P, Mulligan R. The ARRIVE guidelines, a welcome improvement to standards for reporting animal research. J Gene Med. 2010;12(7):559–60.
Drummond GB, Paterson DJ, McGrath JC. ARRIVE: new guidelines for reporting animal research. J Physiol. 2010;588(Pt 14):2517.
Karp NA, Meehan TF, Morgan H, Mason JC, Blake A, Kurbatova N, et al. Applying the ARRIVE guidelines to an in vivo database. PLoS Biol. 2015;13(5):e1002151.
Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol. 2010;8(6):e1000412.
Lapchak PA, Kirkeby A, Zivin JA, Sager TN. Therapeutic window for nonerythropoietic carbamylated-erythropoietin to improve motor function following multiple infarct ischemic strokes in New Zealand white rabbits. Brain Res. 2008;1238:208–14.
Lapchak PA, Daley JT, Boitano PD. A blinded, randomized study of L-arginine in small clot embolized rabbits. Exp Neurol. 2015;266:143–6.
Mokin M, Snyder KV, Siddiqui AH, Levy EI, Hopkins LN. Recent endovascular stroke trials and their impact on stroke systems of care. J Am Coll Cardiol. 2016;67(22):2645–55.
Henninger N, Fisher M. Extending the time window for endovascular and pharmacological reperfusion. Transl Stroke Res. 2016;7(4):284–93.
Goyal M, Yu AY, Menon BK, Dippel DW, Hacke W, Davis SM, et al. Endovascular therapy in acute ischemic stroke: challenges and transition from trials to bedside. Stroke. 2016;47(2):548–53.
Lyden P, Weymer S, Coffey C, Cudkowicz M, Berg S, O'Brien S, et al. Selecting patients for intra-arterial therapy in the context of a clinical trial for neuroprotection. Stroke. 2016;47(12):2979–85.
Acknowledgments
This article was written without direct financial support from government sources (PAL). PAL is supported by pharmaceutical industry grants and donations. JHZ was supported by NIH (NS081740 and NS084921).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of Interest
PAL is Editor-in-Chief, Journal of Neurology & Neurophysiology and Associate Editor, Translational Stroke Research; JHZ is Editor-in-Chief, Translational Stroke Research Editor-in-Chief, Medical Gas Research.
Rights and permissions
About this article
Cite this article
Lapchak, P.A., Zhang, J.H. Data Standardization and Quality Management. Transl. Stroke Res. 9, 4–8 (2018). https://doi.org/10.1007/s12975-017-0531-9
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12975-017-0531-9