The OpenClinica Platform
The use of EDC technology in clinical trials changed dramatically with the development of OpenClinica software, according to Akaza Research, which sponsored the “OpenClinica” meeting. “One of the key trends in electronic data capture is the move toward more flexible, more easily consumable software, and as far as we’re concerned, that means a move toward open source,” said Benjamin Baumann, co-founder and director of business development.
“The OpenClinica technology is developed and distributed under an open-source license, which means that the product is available to anyone who wants to use it. Developers also have access to the underlying source code, which makes OpenClinica a very transparent technology.” With OpenClinica, site coordinators just need a browser with Internet access to enter their data.
“OpenClinica has been out there for at least five years, and we’ve been using it for the last four years. Over the last two years, OpenClinica has gotten a lot better and some of that improvement can be attributed to the nature of the open-source world,” Paul explained. “You have a lot of people using, suggesting, and/or modifying OpenClinica to fix various bugs in the software program.”
To collect data from Phase I and II trials, Social and Scientific Systems relies on case report forms using OpenClinica as a data repository, according to Naji Younes, Ph.D., principal scientist.
Essentially, data entry clerks, located at various locations across the country, key in the data that is received electronically through OpenClinica. “Once the case report forms become available for data entry, they are scanned in a central scanning facility, quality controlled and verified, and then the image of that case report form appears at the keyers’ location.
“What comes out of OpenClinica is data that has to be transformed into a format that can be read by statistical analysis software (SAS), the primary language that we use for data analysis.”
Modern EDC systems are typically web based, which is the feature that makes them readily available to clinical trial coordinators. “Web-based data-capture systems usually have a relational database at the back end. The fact that the captured data is stored in a relational database dictates how it is organized. At the other end, statisticians analyze data that is in SAS. The goals of SAS and the goals of a relational database are pretty different and the transformation requires some thought.” According to Dr. Younes, Social and Scientific Systems is working on merging those two different worlds.
Every clinical trial involves the collection of complex data with each trial containing different levels of complexity. “We do not have the luxury of being able to build from scratch custom pieces for every study. Every piece of software used in a pharma study has to be validated so it is to your advantage to build generic stuff that is clever enough to adapt itself to the idiosyncrasies of a trial. And that is just one of the issues when you are extracting data from OpenClinica,” Dr. Younes added.