OpenClinica 3.0 Features Preview – Part I

We have been working hard on OpenClinica 3.0 for the last 9 months and are getting closer and closer to a production release ready for use in live clinical studies. In the meantime, I wanted to talk about some of the new features over the next few weeks to let folks know what is coming.

OpenClinica 3.0 is sure to bring a lot of excitement to all users of the rapidly growing open source electronic data capture system. A lot of focus in this release has been put on the way trial sponsors use an EDC system and I’d like to point out some of the new features that should enhance their user experiences.

OpenClinica 3.0 will provide a new home page to study-level users providing key information about the progress of a study. These users will be able to see a summary of the subjects enrolled at each site compared to their expected total enrollment as well as the overall subject enrollment for the complete study. Also, these study-level users will be shown a count of the number of study events that are in a particular status. A summary for the number of subject statuses will be displayed so the study-level user can easily see how many subjects are signed, source data verified etc.

OpenClinica 3.0 will provide monitors a workspace to source data verify subjects and their data. The workspace will allow users to source data verify information collected at each visit one-by-one, or verify the information in a bulk process. These two options allow the monitors to perform remote source data verification daily for subjects in the study. Or, if the monitor has to be on site to review and verify information, he/she can go back to their hotel room and check-off verification for many subjects and events at once so they do not have to go one-by-one through every subject and event CRF.

The top-level navigation in OpenClinica 3.0 has been streamlined so site users of the application understand exactly what they have to do after they login. A new home page for investigators and clinical research coordinator users will show the number of queries assigned to them with a link to see every Query assigned them. The home page will show the 5 most recent queries to give the user an idea of what they need to respond to that day.

The new navigation points to the 3 main actions the site users should take. The “Subject Matrix” link will bring them to the new and improved subject matrix in OpenClinica. This matrix will allow users to easily add subjects, schedule events and even enter data from a single, powerful screen. The “Add Subject” link will bring them to a page where they can add a new subject to the study. “Notes & Discrepancies” will bring them to a page where they can see all the queries for their site and allow them to provide a response.

Above is just a small sample of the new features in OpenClinica 3.0. Like I said, I will plan on posting additional features once a week so be sure to check back often. In the meantime, please feel free to download the alpha2 at http://svn.akazaresearch.com/OpenClinica-3.0-distros/.

- Paul Galvin

OpenClinica at International Conference on Global Health

Akaza Research will be presenting OpenClinica at the upcoming International Conference on Global Health in Washington, DC. The conference runs from May 26-30 at the Omni Shoreham Hotel. More information about the event at http://www.globalhealth.org/conference_2009/.

We hope to see you there!

OpenClinica European Summit

Close to 100 OpenClinica users recently came together face to face in Brussels for the OpenClinica European Summit, the first event of its kind for the OpenClinica community. The half-day event was packed with 15 rapid-fire presentations along three key themes: case studies using OpenClinica, regulatory considerations, and integration & standards.

The quality of the presentations was excellent. I learned a tremendous amount about how OpenClinica is being used in a variety of research settings. It was inspiring to see so many enthusiastic users, and I think we all benefited from the opportunity to talk and network face to face. Plus, Brussels is a great place to visit in the spring!

OpenClinica at 2009 ACRP Global Conference and Expo

Hello from Denver! OpenClinica is well represented at the 2009 Global Conference & Exposition here in Denver, Colorado. Akaza Research is hosting an OpenClinica exhibit and providing demonstrations of OpenClinica in booth 511, so be sure and stop by if you’re attending! On Monday at 11:30am, Cal Collins (Akaza’s CEO) will be delivering a presentation titled “Using open source software and CDISC in regulated clinical trials.”

In coming weeks Akaza Research will also be doing OpenClinica presentations and exhibits at the following conferences:

• Society for Clinical Trials Annual Meeting, May 3-6 (Atlanta, GA)
• 30th Annual International Conference on Global Health, May 26-30 (Wasington, DC)
• Drug Information Association Annual Meeting, June 21-25 (San Diego, CA)

Let us know if you’re planning on attending any of these!

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 https://www.openclinica.org/European_Summit.html.

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!

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.

How a Busy Research Clinical Laboratory Deploys OpenClinica as a Laboratory Information System (LIS)

Here at Geneuity Research Services, we do laboratory tests for clients
conducting clinical trials. We are a one-­stop shop, handling everything
from routine clinical assays to esoteric molecular analyses. We use
OpenClinica as an in-­house LIS to keep track of work­flow and to help
with administrative tasks like billing and specimen archiving. This isn’t
exactly what the developers of OpenClinica had in mind originally. The
application was designed from the point of view of trial sponsors, not their
subcontractors. But it works very well for us nonetheless. In this article,
we briefly describe how we do it.

As everybody who uses OpenClinica knows, defining your event x
CRF matrix is the most important step in configuring a trial. When a
client comes to us with a new trial, we do just that. We are careful
to reproduce the anticipated flow of events and patient groupings
just as designated by the trial’s specifications. “Why bother?”
you’re probably asking. “You’re just a subcontractor. That’s not your
concern.” But it is. Invariably, specimens get mislabeled and
inappropriate tests get ordered, and we’re able to detect many such
mistakes by doing a quick visual inspection of OpenClinica’s patient
x event dashboard with its easy-­to-­take-­in iconification. We feel
that this double-checking is part of our service to the sponsor.

CRF design is our next consideration. In this case, we don’t
try to reproduce everything required from the sponsor’s point of
view. Instead, we design a set of CRF’s that reflects just our role
as a contract clinical laboratory. This means that our CRF’s are far
more narrowly focused and less complicated. But it also means we
include some unique types of fields for pricing, specimen archiving
and the like, items that a trial sponsor usually doesn’t need to
address in their CRF’s but which are very helpful to us.

We are very careful how we name our items when crafting our
CRF’s. Specifically, we use the same terminology across our trials
whenever possible. For instance, the field for a specimen’s accession
number is always named ‘accession_number‘. Likewise, we consistently
use the names ‘freezer‘, ‘received_date‘, ‘price‘, ‘shipping_deviation‘
and ‘%assay_date‘ (where % is the wildcard string).

Using such a controlled vocabulary is vital in our case because
we use a separate installation of OpenClinica for each study and
employ the postgresql contrib module ‘dblink’ to federate their
attendant databases for querying. A helter­skeleter vocabulary would
render the latter problematic, to say the very least.

For example, we wrote a federated database procedure we call
accessions(). When executed, it consults the accession_number field
in all our installations and returns the number of accessioned
specimens broken down by trial name. This table lists some of the
federated procedures we’ve developed and their functionality.
Collectively, they provide us with a real­time, global snap­shot of
our work­flow and freezer contents.

Because OpenClinica is web­-based and has finely grained user
roles, our clients can remotely log into their respective
installations at our site with read­-only privileges and see the
status of their specimens whenever they want. Conversely, when we
think a specimen has been mislabeled or have some other issue, we can
call a client and direct them to a particular URL displaying the
pertinent information and seek clarification. OpenClinica thus
becomes a shareable laboratory notebook between us and our clients.

The bottom­line: OpenClinica works for Geneuity. Because
OpenClinica is open source, elegantly designed and well documented,
we are able to tailor the application to our needs. In the spirit of
mutual collaboration and aid fostered by OpenClinica’s lead
developers at Akaza Research, we’re making our federated procedures
freely available. They can be downloaded here.

Using OpenClinica for ICF-Based Data Acquisition

The use of electronic data capture (EDC) systems in health care, and especially in clinical trials, has been the object of significant research given the potential advantages like improved data quality, reduced cost, and increased trial repeatability. Despite significant interest and promised benefits, real adoption has been somewhat limited to date with most successful implementations performed in the field of pharmaceutical clinical trials. This can be attributed in part to the lack of underlying consistent and reusable internal data models and the high cost and complexity in customizing most EDC systems.

A potential alternative to traditional EDC software is the use of Open Source Software (OSS), broadly defined as software that is distributed as a freely available and freely modifiable system. This freedom gives the user the opportunity to perform structural modifications and adaptations to better integrate the software with pre-existing IT infrastructures, or to adapt it to local needs and requirements. There are many examples of large scale open source software (OSS) systems in health care, including the VISTA electronic health record system, used in the US Department of Defense and in several hundred installations across the world, the Care2X system, Indivo health, and the OpenClinica EDC system. The use of open source software facilitates the harmonization of a coherent and comprehensive data model that can be reused across different systems. In our work, ICF (the WHO classification for functioning and disability) has been selected as the underlying representational model, and implemented in the OpenClinica EDC software. The experimentation involved more than 10 Italian regions, with multiple hospitals and care centers. The EDC system was designed to test the effectiveness of ICF as a basis for data collection on disability and functioning in a wide spectrum of pathologies.

The complete WHO-ICF classification was imported from the CLAmL XML representation into the LexGrid editor, a tool created by Mayo Clinic for the purpose of editing and maintaining ontologies and classifications. Starting from this intermediate representation, the classification was first translated into the Italian language and then exported back into the CLAmL representation; this form was also used as the basis for the creation of the internal EDC data model, later imported into the OpenClinica platform. From this visual representation, a group of experts designed the set of forms that comprise the web application; later, the database structure and the final application templates were fixed and published on a public web site. The joint use of ICF as a representational model for an Electronic Data Capture system, coupled with the choice of open source software, yielded a significant reduction in the cost and implementation time of a multiregional EDC system. The ease of use of the web interface also facilitated interactions with medical experts to quickly implement alternative data representations and to create a stable and fast platform that is currently being used in an actual trial. OpenClinica demonstrates that open source is stable and ready to be used even in the strictest clinical trials, and that by using open source it is possible to create clinical research applications in a faster and more cost effective way.

- Carlo Daffara, Connecta