Possible Combinations of Electronic Data Capture and Randomization SystemsPrinciples and the Realization with RANDI2 and OpenClinica
28 June 2013
accepted: 30 February 2014
20 January 2018 (online)
Background: Clinical trials (CT) are in a wider sense experiments to prove and establish clinical benefit of treatments. Nowadays electronic data capture systems (EDCS) are used more often bringing a better data management and higher data quality into clinical practice. Also electronic systems for the randomization are used to assign the patients to the treatments.
Objectives: If the mentioned randomization system (RS) and EDCS are used, possibly identical data are collected in both, especially by stratified randomization. This separated data storage may lead to data inconsistency and in general data samples have to be aligned. The article discusses solutions to combine RS and EDCS. In detail one approach is realized and introduced.
Methods: Different possible settings of combination of EDCS and RS are determined and the pros and cons for each solution are worked out. For the combination of two independent applications the necessary interfaces for the communication are defined. Thereby, existing standards are considered. An example realization is implemented with the help of open-source applications and state-of-the-art software development procedures.
Results: Three possibilities of separate usage or combination of EDCS and RS are pre -sented and assessed: i) the complete independent usage of both systems; ii) realization of one system with both functions; and iii) two separate systems, which communicate via defined interfaces. In addition a realization of our preferred approach, the combination of both systems, is introduced using the open source tools RANDI2 and Open-Clinica.
Conclusion: The advantage of a flexible independent development of EDCS and RS is shown based on the fact that these tool are very different featured. In our opinion the combination of both systems via defined interfaces fulfills the requirements of randomization and electronic data capture and is feasible in practice. In addition, the use of such a setting can reduce the training costs and the error-prone duplicated data entry.
- 1 Schwartz D, Flamant R, Lellouch J. Clinical Trials.. New York: Academic Press Inc; 1980
- 2 Altman DG, Bland JM. Treatment allocation in controlled trials: why randomise?. BMJ 1999; 318 7192 1209-1209.
- 3 Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz I R. Stratified Randomization for Clinical Trials.. J Clin Epidemiol 1999; 52 (01) 19-26.
- 4 Hu F, Rosenberger WF. The Theory of Response-Adaptive Randomization in Clinical Trials. 1st ed. John Wiley & Sons. 2006
- 5 Welker JA. Implementation of electronic data capture systems: Barriers and solutions.. Contemp Clin Trials 2007; 28 (03) 329-336.
- 6 Pavlović I, Kern T, Miklavčiĉ D. Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study. Contemp Clin Trials 2009; 30 (04) 300-316.
- 7 Meyer J, Fredrich D, Piegsa J, Habes M, van den Berg N, Hoffmann W. A mobile and asynchronous electronic data capture system for epidemiologic studies.. Comput Methods Programs Biomed 2013; 110 (03) 369-379.
- 8 Franklin JD, Guidry A, Brinkley JF. A partnership approach for Electronic Data Capture in small-scale clinical trials.. J Biomed Inform 2011; 44 (Suppl. 01) Supplement S103-S108.
- 9 Zelen M. Play the winner rule and the controlled clinical trail.. J Am Stat Assoc 1969; 64: 131-146.
- 10 Day S, Fayers P, Harvey D. Double Data Entry: What Value, What Price?. Control Clin Trials 1998; 19 (01) 15-24.
- 11 CDISC ODM (Internet). Clinical Data Interchange Standards Consortium; c2013 (cited June 28). CDISC Operational Data Model; Available from. http://www.cdisc.org/odm
- 12 Kuchinke W, Wiegelmann S, Verplancke P, Ohmann C. Extended Cooperation in Clinical Studies through Exchange of CDISC Metadata between Different Study Software Solutions.. Methods Inf Med 2006; 45: 441-446.
- 13 Kuchinke W, Aerts J, Semler SC, Ohmann C. CDISC Standard-based Electronic Archiving of Clinical Trials. Methods Inf Med 2009; 48: 408-413.
- 14 Curbera F, Duftler M, Khalaf R, Nagy W, Mukhi N, Weerawarana S. Unraveling the Web services web: an introduction to SOAP, WSDL, and UDDI.. Ieee Internet Comput 2002; 6 (02) 86-93.
- 15 W3C (Internet). World Wide Web Consortium; c2013 (cited December 02). Available from. http://www.w3.org/
- 16 secuTrial® [Internet]. interActive Systems GmbH; c2013 [cited December 02]. SecuTrial® - web-based data capture in clinical trials. Available from. http://www.secutrial.com/
- 17 OpenClinica (Internet). OpenClinica, LLC; c2013 (cited December 02). OpenClinica 3.1 User Documentation; Available from. https://docs.openclinica.com/3.1/
- 18 Randomizer (Internet). Medical Univeristy of Graz; c2013 (cited December 02). Web-Based Patient Randomization (Randomisation) Service for Multi-Center Clinical Trials. Available from. http://www.randomizer.at
- 19 RANDI2 (Internet); c2013 (cited December 02). RANDI2 open-source web-based randomization. Available from:. http://www.randi2.org
- 20 Saghaei M. Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials.. Journal of Biomedical Science and Engineering 2011; 4: 734-739.
- 21 Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research Electronic Data Capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support.. J Biomed Inform 2009; 42: 377-381.
- 22 Schrimpf D, Plotnicki L, Pilz L. Web-based open source application for the randomization process of clinical trials: RANDI2.. Int J Clin Pharmacol Ther 2010; 48: 465-467.
- 23 Rosenberger WF, Lachin JM. Randomization in Clinical Trials: Theory and Practice. 1st ed.. John Wiley & Sons. 2002
- 24 Zelen M. The randomization and stratification of patients to clinical trials.. J Chronic Dis 1974; 27 7-8 365-375.
- 25 Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials.. Control Clin Trials 1988; 9 (04) 345-364.
- 26 Han B, Enas NH, McEntegart D. Randomization by minimization for unbalaced treatment allocation.. Stat Med 2009; 28: 3329-3346.
- 27 Liang Y, Carriere KC. Stratified and randomized play-the-winner rule.. Stat Methods Med Res 2008; 17 (06) 581-593.