How Do You Sell "Free?"
The free-to-download, free-to-modify code makes for a challenging business model. Still, there is a market in offering a fix. Open-source vendors create a distinction between free and paid "Enterprise" versions using some combination of additional services such as technical support, quality testing, proprietary add-on utilities, certification, and training.
By including these perks, they ameliorate the shortcomings of classical open-source, for a price, usually a fraction of competing costs. This is the case with OpenClinica, a clinical electronic data capture solution. Everyone can download the same base software, but only paid users receive validation, hosting, support, etc.
Though this blurs the lines of open- and closed-source, the confusion doesn't stop there. Other licenses such as for the molecular dynamics tool Amber are not free but do include the source; the prices are split between $400 per non-profit/academic site and $20,000 for commercial sites. Finally, premium tools such as Accelrys' Discovery Studio integrate open-source molecular dynamics tool NAMD with closed-source tools together in one giant package.
The question of which software option to use comes down to two main questions: What are your employees familiar with, and what is their time worth? Cash-strapped academic labs have shown that open-source software options are generally up to the task, but tweaking, fiddling, fixing, and searching is often necessary to get them running properly.
Once an open-source tool reaches a threshold of usability, though, schools start to integrate it into curricula; a phenomenon that will only become more common as library and software budgets are slashed. OpenClinica generated interest in academic circles after it was featured in PLoS Medicine, and its free version was demonstrated in an independent investigator-run 400-patient study.
It's already made its way into a course at the Bioinformatics Institute of India and been picked up by several CROs including Athena Healthcare in China, Qualitix in Taiwan, and Emphron in Australia. This is a small fraction of the market, but it's a start, and as areas like China and India grow in wealth, so too will the value of those CROs. Open-source software could take over newer, smaller, and poorer CROs that have fewer patients and could expect a greater fraction of licensing overhead.
Even so, changing software is a relatively small modification. If you could afford Oracle Clinical or one of the other commercial packages, then clinical trial workflow will not be particularly altered. For those who couldn't, however, data collection and dissemination will become much easier.
Open-source represents an answer to software piracy, price-gouging, vendor lock-ins, and abandoned code. It comes with just one question: Who wants to install it?