Data Standardization and Quality Management

被引:15
作者
Lapchak, Paul A. [1 ]
Zhang, John H. [2 ]
机构
[1] Cedars Sinai Med Ctr, Dept Neurol & Neurosurg, Translat Res, Adv Hlth Sci Pavil,Suite 8305, Los Angeles, CA 90048 USA
[2] Loma Linda Univ, Sch Med, Ctr Neurosci Res, 11175 Campus St, Loma Linda, CA 92350 USA
关键词
Translational; Neuroprotection; Neuroprotective; Cytoprotection; Brain; Stroke; Embolic; Hemorrhage; Clinical trial; NIHSS; STAIR; RIGOR; Transparency; Animal research; Drug discovery; STROKE RESEARCH; ARRIVE GUIDELINES; THERAPY; RECOMMENDATIONS; CHALLENGES; OPTIMIZE; MODELS; IMPACT; TRIALS; WINDOW;
D O I
10.1007/s12975-017-0531-9
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
引用
收藏
页码:4 / 8
页数:5
相关论文
共 35 条
  • [1] The Importance of Considering Sex Differences in Translational Stroke Research
    Ahnstedt, Hilda
    McCullough, Louise D.
    Cipolla, Marilyn J.
    [J]. TRANSLATIONAL STROKE RESEARCH, 2016, 7 (04) : 261 - 273
  • [2] Benjamin EJ, 2018, CIRCULATION, V137, pE67, DOI [10.1161/CIR.0000000000000558, 10.1161/CIR.0000000000000485, 10.1161/CIR.0000000000000530]
  • [4] The ARRIVE guidelines, a welcome improvement to standards for reporting animal research
    Danos, Olivier
    Davies, Kay
    Lehn, Pierre
    Mulligan, Richard
    [J]. JOURNAL OF GENE MEDICINE, 2010, 12 (07) : 559 - 560
  • [5] Stroke research at a road block: the streets from adversity should be paved with meta-analysis and good laboratory practice
    Dirnagl, Ulrich
    Macleod, Malcolm R.
    [J]. BRITISH JOURNAL OF PHARMACOLOGY, 2009, 157 (07) : 1154 - 1156
  • [6] ARRIVE: new guidelines for reporting animal research
    Drummond, Gordon B.
    Paterson, David J.
    McGrath, John C.
    [J]. JOURNAL OF PHYSIOLOGY-LONDON, 2010, 588 (14): : 2517 - 2517
  • [7] Impact of Comorbidities on Acute Injury and Recovery in Preclinical Stroke Research: Focus on Hypertension and Diabetes
    Ergul, Adviye
    Hafez, Sherif
    Fouda, Abdelrahman
    Fagan, Susan C.
    [J]. TRANSLATIONAL STROKE RESEARCH, 2016, 7 (04) : 248 - 260
  • [8] Recommendations for standards regarding preclinical neuroprotective and restorative drug development
    Feinklestein, SP
    Fisher, M
    Furland, AJ
    Goldstein, LB
    Gorelick, PB
    Kaste, M
    Lees, KR
    Traystman, RJ
    Albers, GW
    Anwer, UE
    Ashwood, T
    Barone, FC
    Basta, SL
    Bogousslavsky, J
    Buchan, AM
    Cady, WJ
    Chan, PH
    Clemens, JA
    Cox, BF
    Craddock, RE
    Cramer, SC
    del Zoppo, GJ
    Dielrich, WD
    Elliott, P
    Faden, AI
    Feuerstein, GZ
    Ginsberg, MD
    Gold, M
    Greene, WL
    Hall, ED
    Hsu, CY
    Hunter, AJ
    Lai, M
    Lesko, LM
    Levy, DE
    Li, FH
    Locke, KW
    Lodge, D
    Lowe, D
    Marcoux, FW
    McCulloch, J
    McDermott, J
    Meibach, R
    Messersmith, EK
    Moseley, M
    Moskowitz, MA
    Mueller, AL
    Munro, F
    Nudo, RJ
    Oeda, J
    [J]. STROKE, 1999, 30 (12) : 2752 - 2758
  • [9] ARRIVE and CONSORT guidelines: do they have a place in Veterinary Anaesthesia and Analgesia?
    Flammer, Shannon M. Axiak
    Trim, Cynthia M.
    [J]. VETERINARY ANAESTHESIA AND ANALGESIA, 2016, 43 (01) : 2 - 4
  • [10] Endovascular Therapy in Acute Ischemic Stroke Challenges and Transition From Trials to Bedside
    Goyal, Mayank
    Yu, Amy Y. X.
    Menon, Bijoy K.
    Dippel, Diederik W. J.
    Hacke, Werner
    Davis, Stephen M.
    Fisher, Marc
    Yavagal, Dileep R.
    Turjman, Francis
    Ross, Jeffrey
    Yoshimura, Shinichi
    Miao, Zhongrong
    Bhatia, Rohit
    Almekhlafi, Mohammed
    Murayama, Yuichi
    Sohn, Sung-Il
    Saver, Jeffrey L.
    Demchuk, Andrew M.
    Hill, Michael D.
    [J]. STROKE, 2016, 47 (02) : 548 - 553