How Open Source EDC Can Make Clinical Trials More Productive

Barbara Zwick, from the European clinical trial Evidence and Performance Blog recently published an interview with Ben Baumann, Director of Business Development at Akaza Research. The interview discusses how open source EDC (Electronic Data Capture) clinical trials software can help enhance product time to market and overall productivity of clinical trials. Here are some excerpts from the interview:

[BZ] Today’s big Pharma R&Ds are increasing their demand for efficiency and effectiveness. How are you facing this accelerating demand for speed to market?

[BB] There are a number of ways that OpenClinica can accelerate time-to-market. First, open source software can be much easier and quicker to evaluate and get up and running than proprietary software. People can readily install it and experiment with it. Potential adopters can readily inspect everything down to the source code and directly interact with other members of the OpenClinica community to get rapid, unbiased, real-world feedback.

In addition to a full set of EDC and CDM features one might expect in such a system, OpenClinica has  built-in features that give users the ability to set-up their own studies. Therefore, an organization can get a complete picture of how well the system will work for them before committing to use it.

In short, an organization can make a rapid and highly informed decision whether or not to use OpenClinica without having to go through lengthy vendor-biased demonstrations and negotiations, and rely on a vendor in order to get their studies configured appropriately.

[BZ] How can technologies serve to clinical trial performance, to minimize costs and time to market, and to allow rapid decision making? Are innovative EDC technologies, like your platform, more performant and focused on this specific need, rather than ‘old-fashioned’ EDC Solutions?

[BB] Aside from features of the product and benefits of the open source model described above, Akaza Research’s business model for support is designed to maximize productivity of clinical trials. Our support is comprehensive and highly flexible, so customers are able to obtain support packages tailored to their needs. In addition, our customers find our support to be of extremely high quality-after all support is our primary source of revenue.

Most of our support isn’t priced “per study” so clients are able to amortize their investment over numerous studies and don’t have to go through a lengthy contracting process for each new clinical trial they want to use OpenClinica for. This can really help to minimize costs and accelerate the set-up time for new studies.

[BZ] What are the pro and cons of an open source technologies versus a classical technology in the SaaS model?

[BB] First, OpenClinica is available under both a SaaS model and local deployment. Open source has a number of benefits over “classical” proprietary EDC systems. Here are a few examples:

–  Reduce vendor lock-in. Numerous proprietary EDC companies have failed and gone out of business. Open source products exist and evolve independently of any particular vendor, so if one vendor ceases to exist, there are others readily available to take their place.

–  Improved security. Open source software is frequently more secure and bug free than proprietary software. The open source code is continuously (and often intensely) scrutinized by large community developers and security experts. As a result bugs and security issues are found and fixed usually before they become real problems.

–  Readily customizable. Open source systems can be readily customized and extended–you don’t need to rely on a vendor who may or may not make the software modifications you need. If the system doesn’t work the way to want it to, you can change it.

–  Enhanced validation. Validation can be much more thorough with open source software. Buying proprietary software is like buying a car with the  hood welded shut-you don’t know what’s really know going on behind the scenes. Open source provides the highest level of transparency making it possible to truly validate a system from end-to-end.

OpenClinica European Summit

You may have seen the recent announcement of the OpenClinca European Summit. Akaza is planning this event to reach out to our European user base and provide an opportunity for face to face dialogue, networking, and learning. We’ve got a great lineup of speakers and panelists that we will be announcing soon.

From the announcement:

The first OpenClinca European Summit brings together users, developers, and other interested parties in a structured setting to share information about OpenClinica. Whether you’re already using OpenClinica or considering it for future use, this event is an excellent way to obtain lots of high quality information quickly and interact with real users in the OpenClinica community.

The Summit will take place April 14 in Brussels, followed by optional OpenClinica Intensive End User and Advanced eCRF Development training courses that will run April 15 – 18. Registration is open to all and the early bird deadline is January 30th. For more information see

Hope to see you there!

The State of an Electronic Data Capture Open Source Community

I believe we’ll look back at 2008 as the year the OpenClinica open source community truly coalesced. From a size perspective we grew to over five thousand members, double the size of a year ago. Numbers of downloads, new registrations, and adopters in production all increased dramatically. However, the real substantive change has been in the emergence of committed individuals and organizations who participate in the community in meaningful ways.

As evidence of this, the first OpenClinica Community Virtual Forum took place in December. The goals of the forum are to provide an open environment to share ideas, promote collaboration within the community, and determine future direction in the use and development of the OpenClinica electronic data capture software. The meeting topics ranged from new feature development to how to make the development process more accessible to contributors. You can review the minutes here. Participants joined from industry and academia, from software development and data management backgrounds, and were able to share their ideas, experiences, and needs. Many of these participants are doing their own customization/extension of OpenClinica while others are providing detailed feeback and design ideas. We’ve previously discussed motivations for contributing to open source and it’s great to see it work in practice.

The next Virtual Forum will be in February 2009, and every other month thereafter. Participation is open to all, though we are limiting the size of the group to ensure productive discussion.

And that’s not all that’s happening. If you’re on one of our mailing lists you’ll have noticed the greater frequency and depth of discussion threads. The number of code contributions and branches of the OpenClinica code is increasing every month. On a related note, we will soon be announcing the first face-to-face OpenClinica User & Developer Summit.

All of this puts us in an exciting position as we start 2009. The OpenClinica community will continue to advance the vision of bringing free, open, standards-based EDC to users all over the world. This vision will grow with the enthusiasm of community members who don’t want to pay six or even seven-figure license fees, who want the freedom to integrate, customize, and control their software, and benefit from the knowledge and expertise of a transparent worldwide community. Our progress in 2008 and plans for 2009 illustrate that we are on our way!

Open Source in the News for Life Sciences

My schedule’s been quite busy the past few weeks and I haven’t yet been able to complete my series of posts outlined here on open source EDC topics. I promise I’ll get back to it soon. In the meantime, I’d encourage you to check out the latest issue of the Lazlo Letter and their discussion of open source software making inroads into biopharma, in electronic data capture, clinical trials management, online collaboration, and document management. I’m an avid reader of this blog and it’s great to see his perspective on open source.

In other exciting developments, Eli Lilly has made its Life Sciences Grid open source. It’s available on Sourceforge.

I love the smell of politics in the morning

Unless you have been living under a rock for the last six months, you will have noticed that voters in Iowa and New Hampshire are casting votes for the next candidates for our presidential elections in November.

One of the links making the rounds of healthcare-based blogs is this link, which leads to a breakdown of each candidate’s position on healthcare reform.  Some interesting points from the above, and the slightly more photogenic

  • Hillary Clinton is supporting a “paperless” health information technology system in order to reduce costs.
  • Barack Obama plans to invest $50 billion toward adoption of electronic medical records and other health information technology.
  • Bill Richardson (Tufts grad, w00t!) would reduce spending on health care administration by providing grants for adoption of health information technology.
  • Denis Kucinich, besides creating a Universal Health Plan, would promote an electronic health record to reduce paperwork.
  • And it’s not just a Democrat thing either; Mitt Romney, Mike Huckabee, and John McCain would promote deployment of Health IT and electronic medical records.

You may ask, what’s this all got to do with the OpenClinica clinical trials software?  Seeing as how we are partially sponsored by the NIH’s Commercialization Assistance Program, this has quite a bit to do with us.  We are focused more and more on the future of electronic data capture, a system that goes hand in hand with electronic health records.

So, as the great American slug-fest we call the Presidential Election 2008 begins, we can look forward to a lively debate about healthcare from all candidates, whether they are red state or blue state.