CloseClinical aims to provide a community environment for academics and professionals interested in health and clinical research informatics.

Until recently, the Oracle Corp's Oracle Clinical, and the Phase Forward's ClinTrial were the only big bosses of the clinical trial management system, with annual costs of tens of thousands of dollars. As a result only big pharmaceutical and biotechnology laboratories could afford such systems, which seem necessary for complying with international requirements of clinical trials.

OpenClinica, by Akaza Research company is in one of rare free and open source softwares available for the management of clinical trials. Another alternative, TrialDB is maintained and developed by a team at Yale University Medical Informatics department. Although copyrighted, it is freely available under GNU licence (which means that it cannot be used or modified for commercial use).

Both systems are web based: OpenClinical uses JSP and TrialDB uses ASP.NET (with Visual Basic.NET behind). They provide a database interface which is able to connect to an Oracle system, although theoretically it would be possible to connect them to any other database such as MySQL and PostgreSQL. TrialDB uses a Microsoft Access data base access internally for creating case report forms. It demands clients to have Internet Explorer as their web browser.

They implement workflows and provide different customizable access groups. Trial DB uses an entity-attribute-value (EVA) architecture which is somehow different from the conventional relational databases.

Although both systems provide modules for design and creation of case report forms (CRFs), the user interface of OpenClinica seems to be more modern and flexible than that of TrialDB for this purpose. Both systems have modules for defining access groups such as administrator, data coordinator, investigator, monitor, and data manager. The creation of annotations and queries is possible with both systems.

TrialDB supports access to a number of controlled vocabularies (e.g., ICD-10, DSM-IV, the Cerner/Multum Drug Lexicon, the NCI Common Toxicity Criteria) during data entry. However, it is more difficult to install and set up -as I understand from its website.

Both systems provide various export formats such as tabulated text, SPSS or SAS. OpenClinica provides also export in Clinical Data Interchange Standards Consortium's (CDISC) format.

In any way, these two sofwares are good initiatives for a new domain of open source projects. At the moment, I think they can also enjoy from some commercial success (especially for OpenClinica).

In a scientific and public health point of view, one should be aware that international requirements such as those demanded by the internationl conference for harmonisation (ICH) are so sophisticated that it has become almost impossible for the developing countries as well as for small and midium sized companies to carry out clinical trials without having a patent software. The arrival of these patented open source softwares is certainly welcomed and appretiated.

Open Clinical website: http://www.openclinica.org/

TrialDB website: http://ycmi.med.yale.edu/TrialDB/index.shtm