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Reviews on Recent Clinical Trials


ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Review Article

Clinical Trial Data Management Software: A Review of the Technical Features

Author(s): Aynaz Nourani, Haleh Ayatollahi* and Masoud Solaymani Dodaran

Volume 14, Issue 3, 2019

Page: [160 - 172] Pages: 13

DOI: 10.2174/1574887114666190207151500

Price: $65


Background: Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.

Methods: Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.

Results: Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.

Conclusion: It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

Keywords: Case Report Forms (CRFs), clinical data management, clinical trial, information technology, medical coding, systems software.

Graphical Abstract
Rorie DA, Flynn RWV, Grieve K, et al. Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology. Br J Clin Pharmacol 2017; 83(9): 1880-95.
Payne PR, Embi PJ, Cimino JJ. Clinical research informatics. In: RL Richesson, Andrews J, Eds. Biomedical Informatics.New York: Springer 2014; pp. 755-77.
Barr R, Carver V, Green K, et al. Good Informatics Practices (GIP) Module: Data Management: HIMSS; 2013.
Prokscha S. Practical guide to clinical data management. 3rd ed. Boca Raton, Florida: Taylor & Francis 2011.
McGraw MJ, George AN, Shearn SP, Haws TF, Hall RL. Principles of Good Clinical Practice. London: Pharmaceutical Press 2010.
Krishnankutty B, Bellary S, Kumar NB, Moodahadu LS. Data management in clinical research: An overview. Indian J Pharmacol 2012; 44(2): 168.
St Germain DC, Good MJ. Data Management in Clinical Trials Principles and Practice of Clinical Research. 4th ed. London: Elsevier 2017.
Gao Q-B, Kong Y, Fu Z, et al. EZ-Entry: A clinical data management system. Comput Biol Med 2008; 38(9): 1042-4.
Arab L, Hahn H, Henry J, et al. Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial. Contemp Clin Trials 2010; 31(2): 138-46.
Amorim RC, Castro JA, da Silva JR, Ribeiro C. A comparison of research data management platforms: Architecture, flexible metadata and interoperability. Universal Access Inf 2017; 16(4): 851-62.
Bryan HE. Web based data management in clinical trials Wiley StatsRef: Statistics Reference Online 2008.
Zasada SJ, Wang T, Haidar A, et al. IMENSE: An e-infrastructure environment for patient specific multiscale data integration, modelling and clinical treatment. J Comput Sci 2012; 3(5): 314-27.
Park JY, Kim DR, Haldar B, et al. Use of the data system for field management of a clinical study conducted in Kolkata, India. BMC Res Notes 2016; 9(1): 20.
Müller J, Heiss KI, Oberhoffer R. Implementation of an open adoption research data management system for clinical studies. BMC Res Notes 2017; 10(1): 252.
Ngari MM, Waithira N, Chilengi R, et al. Experience of using an open source clinical trials data management software system in Kenya. BMC Res Notes 2014; 7(1): 845.
Cavenaugh JS, Snell P, Jeffries D, Waight PA, McConkey SJ. A relational database for management of flow cytometry and ELISpot clinical trial data. Cytometry B Clin Cytom 2007; 72(1): 49-62.
Weiler G, Brochhausen M, Graf N, et al. Ontology based data management systems for post-genomic clinical trials within a European Grid Infrastructure for Cancer Research. Conf Proc IEEE Eng Med Biol Soc 2007; 2007: 6435-8.
Kruse RL, Mehr DR. Data management for prospective research studies using SAS® software. BMC Med Res Methodol 2008; 8(1): 61.
Buchsbaum R, Kaufmann P, Barsdorf AI, et al. Web-based data management for a phase II clinical trial in ALS. Amyotroph Lateral Scler 2009; 10(5-6): 374-7.
Durkalski V, Zhao W, Dillon C, Kim J. A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression. Clin Trials J 2010; 7(2): 174-82.
Pozamantir A, Lee H, Chapman J, Prohovnik I. Web-based multi-center data management system for clinical neuroscience research. J Med Syst 2010; 34(1): 25-33.
Stenzhorn H, Weiler G, Brochhausen M, et al. The ObTiMA system-ontology-based managing of clinical trials. World Congress on Medical Informatics 2010.Cape Town, South Africa.
Wilson AS, Bacon PA, Young SP, Carruthers DM. Vasculitis integrated clinical assessment database: A data management system to support studies into systemic vasculitis. J Clin Rheumatol 2010; 16(1): 10-4.
Das S, Zijdenbos AP, Harlap J, Vins D, Evans AC. LORIS: A web-based data management system for multi-center studies. Front Neuroinform 2011; 5: 37.
Musick BS, Robb SL, Burns DS, et al. Development and use of a web-based data management system for a randomized clinical trial of adolescents and young adults. Comput Inform Nurs 2011; 29(6): 337-43.
Tran V-A, Johnson N, Redline S, Zhang G-Q. OnWARD: Ontology-driven web-based framework for multi-center clinical studies. J Biomed Inform 2011; 44: S48-53.
Li Z, Wen J, Zhang X, et al. ClinData Express–a metadata driven clinical research data management system for secondary use of clinical data. AMIA Annu Symp Proc 2012; 2012: 552-7.
Fraccaro P, Dentone C, Fenoglio D, Giacomini M. Multicentre clinical trials’ data management: A hybrid solution to exploit the strengths of electronic data capture and electronic health records systems. Inform Health Soc Care 2013; 38(4): 313-29.
Cramon P, Rasmussen ÅK, Bonnema SJ, et al. Development and implementation of PROgmatic: A clinical trial management system for pragmatic multi-centre trials, optimised for electronic data capture and patient-reported outcomes. Clin Trials J 2014; 11(3): 344-54.
Micard E, Husson D. Team C-I, Felblinger J. ArchiMed: A data management system for clinical research in imaging. FICT 2016; 3: 31.
Gazali KaurS, Singh I. Artificial intelligence based clinical data management systems: A review. Informatics in Medicine Unlocked ( IMU) 2017; 9: 219-29.
Nourani A, Ayatollahi H, Dodaran M. A review of clinical data management systems used in clinical trials. Rev Recent Clin Trials 2018; 14(1): 27-40.
Lee H, Chapiro J, Schernthaner R, et al. How I do it: A practical database management system to assist clinical research teams with data collection, organization, and reporting. Acad Radiol 2015; 22(4): 527-33.
Fu L, Ding S, Chen T, et al. Clinical Data Management System. In: Biomedical Engineering and Computer Science (ICBECS) conference. 2010.China: IEEE.
Wu Y. Software engineering and knowledge engineering: Theory and Practice. Berlin, Heidelberg: Springer 2012.
Gyori BM, Venkatachalam G, Thiagarajan P, Hsu D, Clement M-V. OpenComet: An automated tool for comet assay image analysis. Redox Biol 2014; 2: 457-65.
Hou Z, Zhou X, Gu J, et al. ASAAS: Application software as a service for high performance cloud computing High Performance Computing and Communications (HPCC). 2010.Melbourne, Australia IEEE.
James KL. Software engineering. New Delhi: PHI Learning 2016.
Buxmann P, Hess T. The Software Industry: Economic Principles, Strategies, Perspectives. Heidelberg: Springer Berlin Heidelberg 2012.
Popp K, Meyer R. Profit from software ecosystems: Business models, ecosystems and partnerships in the software industry. Norderstedt: Books on Demand; 2010.
Ratib O, Rosset A, Heuberger J. Open source software and social networks: Disruptive alternatives for medical imaging. Eur J Radiol 2011; 78(2): 259-65.
Dezeuze A. The ‘Do-it-Yourself’ Artwork: Participation from Fluxus to New Media. Manchester: Manchester University Press 2010.
Nash F, Du Preez A, De Wet C. FCS Computer Programming L4. Cape Town: Pearson Education South Africa 2009.
Bebis G. Advances in visual computing Second International Symposium, ISVC 2006 Lake Tahoe, NV, USA November 6-8, 2006, Proceedings. Berlin: Springer;. 2006.
Wen W, Chen YH, Chen IC. A knowledge-based decision support system for measuring enterprise performance. Knowl Base Syst 2008; 21(2): 148-63.
Lin S, Huang X. Advances in Computer Science, Environment, Ecoinformatics, and Education, Part III International Conference, CSEE 2011 Wuhan, China August 21-22, 2011. Proceedings. Berlin Heidelberg: Springer. 2011.
Mouratidou M, Lourdas V, Chatzigeorgiou A, Georgiadis CK. An assessment of design patterns’ influence on a Java-based e-commerce application. J Theor Appl Electron Commer Res 2010; 5(1): 25-38.
Vojtáš P, Kiyoki Y, Jaakkola H, Tokuda T, Yoshida N. Information Modelling and Knowledge Bases XXIV Amesterdam. IOS Press 2013.
Oluwatosin HS. Client-server model. IOSRJ Comput Eng 2014; 16(1): 2278-8727.
Lu Z, Su J. Clinical data management: Current status, challenges, and future directions from industry perspectives. Open Access J Clin Trials 2010; 2: 93-105.
Ohmann C, Kuchinke W, Canham S, et al. Standard requirements for GCP-compliant data management in multinational clinical trials. Trials 2011; 12(1): 85.
Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of Clinical Trials switzerland. Springer 2015.
Gorrell LM, Engel RM, Brown B, Lystad RP. The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review. Spine J 2016; 16(9): 1143-51.
Wang X, Park JH, Tse J, et al. Development of a web based informatics system utilizing quantitative imaging features for predicting outcomes in stroke rehabilitation clinical trials Medical Imaging 2016: PACS and Imaging Informatics: Next Generation and Innovations. 2016.San Diego International Society for Optics and Photonics.

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