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.

Microsoft Veteran Banks on Open Source

11-year Microsoft veteran, Keith Curtis, has recently published a book on Lulu.com called “After the Software Wars”. In it, Mr. Curtis describes how he believes open source will be the primary innovation engine for many long promised technological developments, such as cars that drive themselves. However, what is particularly interesting is the fact that Mr. Curtis built his career at Microsoft, a company that quite possibly views open source as its single largest threat.

While I haven’t read the book yet, the Web is already abound with abstracts and commentary, including a good summary posted on the New York Times blog by John Markoff. Here’s an excerpt:

“The key to faster technological progress is making software free,” he [Curtis] writes. “The difference between free, and non-free or proprietary software, is similar to the divide between science and alchemy. Before science, there was alchemy, where people guarded their ideas because they wanted to corner the market on the mechanisms used to convert lead into gold.”

He notes that there is an important parallel to the end of the Dark Ages, which came when society began to freely share advancements in math and science.

It is refreshing to see a man who spent 11 years enduring Microsoft propaganda still be able to think outside the confines of the proprietary software paradigm.

Why Pharmaceutical Companies Now Have a Reason to Choose Open Source

On October 27th, Bio-IT World published an article on the newly released OpenClinica 2.5. In a somewhat bold statement the article’s author stated that “Akaza Research has given pharmaceutical companies reason to take heed of the open source movement.” Akaza Research, of course, is the primary commercial force behind OpenClinica, the world’s most popular open source electronic data capture software.

What the author fails to explain, in my opinion, is why this is the case. For instance, I personally do not believe that the larger pharmaceutical companies would choose an open source EDC system for open source’s sake. In other words, the cost and flexibility benefits of open source, while significant, may not offer the same degree of value to Big Pharma as it would to myriad smaller companies. The industry’s largest firms have the financial resources and technical expertise to obtain and utilize essentially any solution in the marketplace and will therefore need a stronger motivation in order to move to open source. And I think that this motivation has to come from the quality of the technology and the overall solution through which it is implemented.

I do not believe OpenClinica would be making such a strong impact in such a short period of time if it weren’t for the robust open source community behind it. It is this community that provides fundamental value to the software. The decentralized efforts of users around the globe fuel OpenClinica’s evolution in a way that is both rapid and driven by true market demand from the trenches. The result is a product containing features that real-world users want and that work in the way these real world users want them to.

The open source community also helps to self-police the quality of OpenClinica distributions. There is a diverse group of users and developers who experiment with beta releases and continuously scour the system source code. From their unbridled vantage points within the community, these people report issues in a frank, public, and uncompromising manner. This transparency and candid public discourse about the software makes it difficult, if not impossible, to cut corners or sweep defects under the rug.

In a sense, with proprietary software you never really know what you’re getting. With open source software you know it all—both the good and the bad. It is the open source community that drives OpenClinica’s success, and this, in my opinion, is why pharmaceutical companies have reason to take heed of OpenClinica.

Why Open Source is Good for International Health Research (and Everyone Else)

A recent article titled, “Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?”, published in PLoS (Public Library of Science) proposes that “international health research organisations combine their efforts and spending power and assist with the development of systems that are open to all.” This is a bold statement with, in my opinion, solid rationale.
 

The authors, Greg W. Fegan and Trudie A. Lang, manage numerous clinical trials for the Kenya Medical Research Institute–Wellcome Trust Collaborative Research Programme in Kilifi, Kenya. Like many other research organizations in developing countries, their work largely focuses on finding treatments for “neglected diseases” such as malaria, hookworm, and encephalopathies. They clearly communicate the inability for proprietary eClinical software to be a widely useable solution in such settings due to costly and restrictive licensing. 
 

However, Fegan and Lang define the appeal of open source as something greater than financial savings (although this is a strong motivation). In addition to freedom from license fees, open source clinical trial software built with open components and open standards is more “modifiable and amenable for use with existing software already employed.” Perhaps the most significant point made is that open source can be a more powerful way to promulgate standards and better leverage the collective efforts of disparate research institutions.
 

Indeed, the authors also point out that the impact of a well designed and supported open source eClinical system “can be beneficial to all clinical researchers” and urge “international health research organisations to combine their efforts and spending power and assist with the development of systems that are open to all and truly fit for purpose.”
 

The paper closes with the following call to action:

“Research organisations and funders should combine efforts to produce an open-source solution for trial data management. A shared platform could then be easily established, and would bring wider benefits such as electronic submission to regulators, automated sharing of data, and contribution to important public databases such as pharmacovigilance and drug-monitoring registries.

We believe that an open-source approach to a truly designed-for-purpose data-management system for clinical trials is attractive. Such a system would save money by eliminating the reliance on the use of expensive database software systems and their administrators. This would empower and enable a wider variety of people to conduct trials, as the question of capturing, cleaning, and extracting data would not be overly daunting or expensive. This point is significant, as it may encourage more investigators in resource-poor settings to take part in high-standard research that would otherwise be out of reach and beyond their capacity. Surely this would increase the scope and variety of trials that are conducted. Our hope for this article is that it will begin a debate on this topic, and lead to a concerted effort to lobby the international research and donor community to make sure this barrier to trial conduct is understood and addressed.”

I encourage you to read the full article online at the PLoS website.