Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?

Fegan, Greg; Lang, Trudie

doi:10.1371/journal.pmed.0050006

Cited by 42 publications

(35 citation statements)

References 9 publications

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“…Despite the benefits, commercial EDC systems are expensive [13] and frequently non-customizable. They have been considered inadequate in context to the needs of healthcare stakeholders (clinicians, administrators, and patients) [46].…”

Section: Commercial Edc Systemsmentioning

confidence: 99%

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Electronic Data Capture for Registries and Clinical Trials in Orthopaedic Surgery: Open Source versus Commercial Systems

Shah

Rajgor

Pradhan

et al. 2010

Clinical Orthopaedics &Amp; Related Research

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Our purposes are (1) to provide a brief overview of EDC systems, their types, and related pros and cons as well as to describe commonly used EDC platforms and their features; and (2) describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system. WHERE ARE WE NOW?: Electronic data capture systems aimed at addressing these issues are widely being adopted at an institutional/national/international level but are lacking at an individual level. A wide array of features, relative pros and cons and different business models cause confusion and indecision among orthopaedic surgeons interested in implementing EDC systems. WHERE DO WE NEED TO GO?: To answer clinical questions and actively participate in clinical studies, orthopaedic surgeons should collect data in parallel to their clinical activities. Adopting a simple, user-friendly, and robust EDC system can facilitate the data collection process. HOW DO WE GET THERE?: Conducting a balanced evaluation of available options and comparing them with intended goals and requirements can help orthopaedic surgeons to make an informed choice.

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Section: Commercial Edc Systemsmentioning

confidence: 99%

“…Despite being feature rich, scalable, secure and compliant to industry standards, these EDC systems are prohibitively expensive [13], thus limiting their use by individual investigators and users from developing countries that do not having adequate funding but are interested in research participation.…”

Section: Commercial Edc Systemsmentioning

confidence: 99%

Electronic Data Capture for Registries and Clinical Trials in Orthopaedic Surgery: Open Source versus Commercial Systems

Shah

Rajgor

Pradhan

et al. 2010

Clinical Orthopaedics &Amp; Related Research

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“…Anecdotal evidence suggests that the reduction in development time may range between 20% and 80%, depending upon the organizational context. Based on the early evaluations mentioned in Section 2, it seems that the reduction in licensing costs can be measured in terms of the cost of a Microsoft Office SharePoint Server select license (of the order of £1000, covering arbitrarily many studies) against that for a typical solution based on commercial domain-specific tools (which "would cost in the range of hundreds of thousands of dollars" [17]). …”

Section: Discussionmentioning

confidence: 99%

Form Follows Function: Model-Driven Engineering for Clinical Trials

Gibbons

2011

Electron. Proc. Theor. Comput. Sci.

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Abstract. We argue that, for certain constrained domains, elaborate model transformation technologies-implemented from scratch in generalpurpose programming languages-are unnecessary for model-driven engineering; instead, lightweight configuration of commercial off-the-shelf productivity tools suffices. In particular, in the CancerGrid project, we have been developing model-driven techniques for the generation of software tools to support clinical trials. A domain metamodel captures the community's best practice in trial design. A scientist authors a trial protocol, modelling their trial by instantiating the metamodel; customized software artifacts to support trial execution are generated automatically from the scientist's model. The metamodel is expressed as an XML Schema, in such a way that it can be instantiated by completing a form to generate a conformant XML document. The same process works at a second level for trial execution: among the artifacts generated from the protocol are models of the data to be collected, and the clinician conducting the trial instantiates such models in reporting observations-again by completing a form to create a conformant XML document, representing the data gathered during that observation. Simple standard form management tools are all that is needed. Our approach is applicable to a wide variety of information-modelling domains: not just clinical trials, but also electronic public sector computing, customer relationship management, document workflow, and so on.It is the pervading law of all things organic and inorganic, Of all things physical and metaphysical, Of all things human and all things super-human, Of all true manifestations of the head, Of the heart, of the soul, That the life is recognizable in its expression, That form ever follows function. This is the law.

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“…Features such as audit trails, double data entry, queries, and data access restrictions make the software useful for both clinical trails and for a number of descriptive epidemiological studies at MRU [3].…”

Section: Softwarementioning

confidence: 99%

Developing Information Technology at the Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné, Gabon

Dibacka

Bounda

Nguema

et al. 2010

Wien Klin Wochenschr

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Information technology has become a key resource for research institutions, providing services such as hardware, software and network maintenance, as well as data management services. The IT department of the Medical Research Unit (MRU) of the Albert Schweitzer Hospital in Lambaréné, Gabon is a good example of how IT has developed at African Research Centres in recent years and demonstrates the scope of work that a modern research centre needs to offer. It illustrates the development in the past 15 years--from single computers maintained by investigators to the present situation of a group of well-trained local IT personal who are in charge of a variety of hardware and software and who also develop applications for use in a research environment. Open source applications are particularly suited for these needs and various applications are used in data management, data analysis, accounting, administration and quality management.

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Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?

Abstract: The authors argue that research organizations and funders should combine efforts to produce an open-source solution for trial data management.

Cited by 42 publications

References 9 publications

Electronic Data Capture for Registries and Clinical Trials in Orthopaedic Surgery: Open Source versus Commercial Systems

Electronic Data Capture for Registries and Clinical Trials in Orthopaedic Surgery: Open Source versus Commercial Systems

Form Follows Function: Model-Driven Engineering for Clinical Trials

Developing Information Technology at the Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné, Gabon

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