|
Open Source SolutionOverviewWhile copyrighted by its creators and developers, TrialDB is freely available under the GNU General Public License. Study managers can download TrialDB and setup the CSDMS locally. But freeware does not mean it is "plug-and-play." Learning to operate it, like the conduct of a multi-centric study itself, requires a significant investment in time and effort, as well as a significant degree of database expertise and Web development skills (because you may wish to customize it for your needs). At least two people are needed to maintain it:
Study designers must understand the domain of clinical trials, and have at least a rudimentary knowledge of the medical field to the extent of being able to ask questions about the domain of the study intelligently. The chance of finding a hardened developer who also knows medicine is very small. TrialDB's two primary developers are probably rather rare in this regard. The study designer must also understand the elements of database design. To a large extent, when you use TrialDB to set up a clinical study, you are faking a relational database design using what is called an Entity-Attribute-Value design. Therefore, it is necessary to understand the principles of database normalization, because you will be setting up your study in accordance with these principles. Just as availability of a relational database engine is no guarantee that databases will be designed correctly, the same caveat applies to TrialDB: a naive designer can easily set up a study incorrectly to the point where data extracts from TrialDB are very difficult to analyze without considerable restructuring by a database expert (or the unfortunate statistician who receives the data). There is often more than one way to set up a given case report form, but in a given circumstance, one may be more appropriate than the others. The designer manual provides detailed guidelines for form design that have been developed through extensive experience. Note for statistics mavens: SAS version 7 has now integrated SQL into its programming language (there's a new command called PROC SQL) - it expects to reach out to production relational databases via ODBC rather than import data physically into SAS-format files- and therefore normalized designs are the way to go. SPSS also lets you compose SQL to access relational databases. Getting HelpIt is said that with free software, you get what you pay for. However, Tom Hoen, formerly of Johns Hopkins, has set up a ListServ for TrialDB at Yahoo! Groups. You will need to get a Yahoo ID in order to join this group. (Make sure, when you do so, that you customize your preferences so that you do not permit Yahoo to spam you - permission to spam is the default.) Several people in the TrialDB community will answer your questions, but remember that you should also be doing your homework. (For example, if you don't know programming in VBA or VB.NET, or relational database technology to the extent that you can administer an Oracle or SQL Server installation or write queries in SQL, start teaching yourself. Until then, TrialDB is not for you.) Getting TrialDBImportant note: TrialDB source code and documentation is currently being updated and in transition. Some information below as well as some code and documentation maybe out of date. We will update information when available. (04/08/09)
For questions regarding TrialDB, please send E-mail to Prakash Nadkarni or Cynthia Brandt . Please remember that, while we do our best to answer our E-mails quite promptly, free software cannot come with support. (We will, however, take the opportunity to use your questions and feedback to improve the quality of the software and the documentation.) |
