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GMDS 2013: 58. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

01. - 05.09.2013, Lübeck

Combination of the electronic data capture system (EDCS) OpenClinica and the randomization system (RS) RANDI2

Meeting Abstract

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  • Daniel Schrimpf - Deutsches Krebsforschungzentrum (DKFZ), Heidelberg, DE
  • Lothar Pilz - Universität Heidelberg - Medizinischen Fakultät Mannheim, Mannheim, DE

GMDS 2013. 58. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). Lübeck, 01.-05.09.2013. Düsseldorf: German Medical Science GMS Publishing House; 2013. DocAbstr.176

doi: 10.3205/13gmds044, urn:nbn:de:0183-13gmds0447

Published: August 27, 2013

© 2013 Schrimpf et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Introduction: Today clinical trials are often realized with the assistance of electronic applications. A basic application is an electronic data capture system (EDCS) supporting the data entry and management. The advantage using such systems is the direct control of entered data and the immediate availability of the patient information. Another important tool is a randomization system (RS) preventing selection bias and reducing unknown influencing factors by random allocation of patients to treatment arms. Advanced (adapted) randomization methods do not use only basic patient information at study entry, but also process data during the study as treatment response to prefer the probably better treatment or to decide the study earlier with fewer patients. Using such complex methods increases the number of necessary patient data. If data collection is handled by an EDCS, preferably the entered data should be instantaneously reused for the randomization process. A realization of such a combination of EDCS and RS is exemplarily shown.

Material and Methods: To show the feasibility and efficacy of such a combination the open source systems OpenClinica [1] and RANDI2 [2] are used, because the open source characteristics of both allows a flexible adaption of the applications for implementing the necessary functions. OpenClinica provides an optional web service component for data access. These web services are based on the SOAP standard wrapping the clinical data standard ODM (operational data model) from CDISC (Clinical Data Interchange Standards Consortium) [3]. Thereby it is possible to realize the communication with external applications as with the RS RANDI2.

Results: OpenClinica provides typical features of an EDCS, like (i) double data entry and query management to reach a better data quality, and (ii) a flexible security concept to support the different user groups. RANDI2 is developed with our participation and provides through its modularized architecture a good basis for the combination with OpenClinica. The necessary interfaces an EDCS has to facilitate are determined in advance and these interfaces are compared with the available services of OpenClinica. Missing web services are identified and implemented. The application RANDI2 was adapted with all essential interfaces, including (i) the import and configuration of an OpenClinica study, (ii) the synchronization of new patient information, and (iii) the randomization with notification of the result by email and in entering the data into OpenClinica. The inter-system communication during the allocation phase takes place automatically, this avoids manual actions for the randomization process and as a consequence, the investigator needs to add a new patient only in OpenClinica.

Discussion: The combination of OpenClinica and RANDI2 allows using data from the EDCS for the randomization. This is especially favorable in case of adaptive randomization methods. The advantage of our approach for investigators is the usage of only one system; randomization is triggered automatically; both resulting in a decreasing training effort. With regard to administration there is no difference between two independent systems and our approach. The randomization process benefits from the usually good data quality


References

1.
OpenClinica LLC [Internet]. OpenClinica – Open Source for Clinical Research. Waltham (MA): 2013. [cited 2013 Apr 15]. Available from: https://openclinica.com/ External link
2.
RANDI2 [Internet]. RANDI2 – an open source randomization solution. Heidelberg: 2013.[cited 2013 Apr 15]. Available from: http://randi2.org External link
3.
CDISC [Internet]. Operational Data Model. Austin (TX): 2013. [cited 2013 Apr 15]. Available from: http://www.cdisc.org/odm External link