Literature DB >> 28283966

Data Standardization and Quality Management.

Paul A Lapchak1, John H Zhang2.   

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.

Entities:  

Keywords:  Animal research; Brain; Clinical trial; Cytoprotection; Drug discovery; Embolic; Hemorrhage; NIHSS; Neuroprotection; Neuroprotective; RIGOR; STAIR; Stroke; Translational; Transparency

Mesh:

Year:  2017        PMID: 28283966     DOI: 10.1007/s12975-017-0531-9

Source DB:  PubMed          Journal:  Transl Stroke Res        ISSN: 1868-4483            Impact factor:   6.829


  35 in total

Review 1.  Endovascular Therapy in Acute Ischemic Stroke: Challenges and Transition From Trials to Bedside.

Authors:  Mayank Goyal; Amy Y X Yu; Bijoy K Menon; Diederik W J Dippel; Werner Hacke; Stephen M Davis; Marc Fisher; Dileep R Yavagal; Francis Turjman; Jeffrey Ross; Shinichi Yoshimura; Zhongrong Miao; Rohit Bhatia; Mohammed Almekhlafi; Yuichi Murayama; Sung-Il Sohn; Jeffrey L Saver; Andrew M Demchuk; Michael D Hill
Journal:  Stroke       Date:  2016-01-07       Impact factor: 7.914

2.  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.

Authors:  Eric A G Blomme
Journal:  Vet J       Date:  2011-09       Impact factor: 2.688

Review 3.  Neurogenesis in Stroke Recovery.

Authors:  Seong-Ho Koh; Hyun-Hee Park
Journal:  Transl Stroke Res       Date:  2016-03-18       Impact factor: 6.829

4.  A blinded, randomized study of L-arginine in small clot embolized rabbits.

Authors:  Paul A Lapchak; Jessica T Daley; Paul D Boitano
Journal:  Exp Neurol       Date:  2015-02-20       Impact factor: 5.330

5.  Selecting Patients for Intra-Arterial Therapy in the Context of a Clinical Trial for Neuroprotection.

Authors:  Patrick Lyden; Sara Weymer; Chris Coffey; Merit Cudkowicz; Samantha Berg; Sarah O'Brien; Marc Fisher; E Clarke Haley; Pooja Khatri; Jeff Saver; Steven Levine; Howard Levy; Marilyn Rymer; Lawrence Wechsler; Ashutosh Jadhav; Elizabeth McNeil; Salina Waddy; Kent Pryor
Journal:  Stroke       Date:  2016-11-01       Impact factor: 7.914

Review 6.  Impact of Comorbidities on Acute Injury and Recovery in Preclinical Stroke Research: Focus on Hypertension and Diabetes.

Authors:  Adviye Ergul; Sherif Hafez; Abdelrahman Fouda; Susan C Fagan
Journal:  Transl Stroke Res       Date:  2016-03-30       Impact factor: 6.829

7.  Scientific Rigor Recommendations for Optimizing the Clinical Applicability of Translational Research.

Authors:  Paul A Lapchak
Journal:  J Neurol Neurophysiol       Date:  2012

Review 8.  The Importance of Considering Sex Differences in Translational Stroke Research.

Authors:  Hilda Ahnstedt; Louise D McCullough; Marilyn J Cipolla
Journal:  Transl Stroke Res       Date:  2016-02-01       Impact factor: 6.829

Review 9.  Stem Cell Therapy and Administration Routes After Stroke.

Authors:  Berta Rodríguez-Frutos; Laura Otero-Ortega; María Gutiérrez-Fernández; Blanca Fuentes; Jaime Ramos-Cejudo; Exuperio Díez-Tejedor
Journal:  Transl Stroke Res       Date:  2016-07-07       Impact factor: 6.829

Review 10.  Neuroimaging as a Selection Tool and Endpoint in Clinical and Pre-clinical Trials.

Authors:  Keith W Muir; I Mhairi Macrae
Journal:  Transl Stroke Res       Date:  2016-08-20       Impact factor: 6.829

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  4 in total

1.  Experimental Aneurysmal Subarachnoid Hemorrhage: Tiding Over.

Authors:  Marcel A Kamp; Hans-Jakob Steiger; Jasper Hans van Lieshout
Journal:  Transl Stroke Res       Date:  2019-09-02       Impact factor: 6.829

2.  "Real world survey" of hydrogen-controlled cancer: a follow-up report of 82 advanced cancer patients.

Authors:  Ji-Bing Chen; Xiao-Feng Kong; You-Yong Lv; Shu-Cun Qin; Xue-Jun Sun; Feng Mu; Tian-Yu Lu; Ke-Cheng Xu
Journal:  Med Gas Res       Date:  2019 Jul-Sep

3.  Developing a systematic approach to assessing data quality in secondary use of clinical data based on intended use.

Authors:  Hanieh Razzaghi; Jane Greenberg; L Charles Bailey
Journal:  Learn Health Syst       Date:  2021-05-03

4.  Reframing the Biological Basis of Neuroprotection Using Functional Genomics: Differentially Weighted, Time-Dependent Multifactor Pathogenesis of Human Ischemic Brain Damage.

Authors:  William A Kofke; Yue Ren; John G Augoustides; Hongzhe Li; Katherine Nathanson; Robert Siman; Qing Cheng Meng; Weiming Bu; Sukanya Yandrawatthana; Guy Kositratna; Cecilia Kim; Joseph E Bavaria
Journal:  Front Neurol       Date:  2018-06-26       Impact factor: 4.003

  4 in total

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