The gradual spread of software automation in drug development may be getting a boost from open source systems. Most e-clinical systems today--from data capture and storage to trial management and operations--are proprietary, despite the excellent work that solutions providers have done to make their products compatible with existing standards-based and de facto standard industry systems.
True to the open source concept, such systems tend to be more accessible to the resource-constrained academic and small biotech sectors, as well as small and mid-size CROs. Open systems are available for free, with no license fee, and they provide an opportunity for interaction with other community members via the shared solution building, refining, and follow-on development that underlies them, says Ben Bauman, director for business development at Akaza Research, in an interview. The company's OpenClinica system is an open-source EDC and data management system.
Akaza recently announced the availability of an expert-reviewed case report form library for OpenClinica, as reported. In addition to providing and overseeing OpenClinica, the company sells an enterprise edition of the product and a suite of products.
The drug industry is a relative laggard when it comes to open systems adoption, as it has been to automation in general. The concept is entrenched in some other industries, including regulated ones. Some prospective drug industry users, however, "think that because they're regulated, they can't use open source systems. There's a fair amount of that," says Bauman.
But it's not true.
The National Cancer Institute's Biomedical Informatics Grid, CaBIG, is one example of an open source system for drug development that provides secure data exchange, says Bauman. CaBIG represents organized efforts to simultaneously create a grid architecture for cancer-community communication and data exchange. Bauman says CaBIG is "helping to usher in open source to the clinical trial space."
About 300 companies around the world use Akaza's OpenClinica, says Bauman. "But we don't really know because anyone can download it. The system has just under 10,000 registered users."
At the same time open source e-clinical systems are evolving alongside their proprietary system counterparts, the open-source concept is not limiting itself to the clinical trial phases, nor to software. GlaxoSmithKline last week said that it is opening up the designs behind 13,500 chemical compounds that are potential precursors of a malaria treatment. The goal is to tap minds outside of GSK and drive a community effort to develop a drug that is not patented by just one company.
- here's an article on the GSK effort