Open Source Software being used in Clinical Research

Although open source has not conquered the lucrative market for electronic health records (EHRs) used by hospital systems and increasingly by doctors, it is making strides in many other important areas of health care. One example is clinical research, as evidenced by OpenClinica in field of Electronic Data Capture (EDC) and LabKey for data integration. Last week I attended a conference for people who use OpenClinica in their research or want to make their software work with it.

At any one time, hundreds of thousands of clinical trials are going on around the world, many listed on an FDA site. Many are low-budget and would be reduced to using Excel spreadsheets to store data if they didn’t have the Community edition of OpenClinica. Like most companies with open-source products, OpenClinica uses the “open core” model of an open Community edition and proprietary enhancements in an Enterprise edition. There are about 1200 OpenClinica installations around the world, although estimation is always hard to do with open source projects.

Although OpenClinica sees plenty of use in well-endowed environments, some of the communities that use it need to shepherd every resource. They may lack Internet connectivity, people educated in system administration, and other infrastructure. The same creativity that goes into an open source community drives these sites to find clever solutions to EDC. Some of the researchers speaking at the conference carry out trials in Africa and rural China.