Forum upgrades and more

OpenClinica CommunityWhen you join OpenClinica as a user or a developer, you are joining an active, collaborative community. Our community is growing and with that growth it is constantly changing. Very soon you’ll see some changes that will allow you to interact with other community members in a richer, more powerful way.

The venerable GNU Mailman list software has been at the heart of the OpenClinica community for many years. It does it’s intended job (user and developer email lists) really well, but does not offer many features beyond that. Next week we are launching a new tool to power how the community works and corresponds.

The new OpenClinica Forums, powered by Vanilla, will offer the ability to post and read via the web. They still support email-based correspondence, so if you prefer to post and read via e-mail, you won’t notice much of a difference from how you’re used to doing things. In addition, the new web interface will have numerous features for search and collaboration that are simple yet powerful.

The forums will be organized into categories by topic. Some will be end-user focused, some will be IT/system admin focused, and some will be developer focused. Others may be a hybrid. If you’re currently subscribed to either the users or developers list, upon launch of the new forums, you’ll be subscribed to receive email from all of forum categories if you wish. However, you can log in to customize your settings to only receive emails from certain categories. If you have an idea for a new category, suggest it on the forums and if there’s support for it in the community we’ll create it for you.

Like any growing community, having a few ground rules about expected behavior is good for everyone. The OpenClinica community already does a great job being respectful and helpful, but it’s good to put the basics in writing so new and old participants alike know what to expect. New Community Guidelines (to be posted next week as well) are designed to help preserve the valuable culture our community has established, and ensure that participants continue to engage in the same meaningful, respectful ways as we grow. The guidelines are modeled off other successful open source communities and should be intuitive to most… however if you have feedback that can improve them, let us know (on the forums of course)!

Last and perhaps most exciting, we’ll soon be launching a new OpenClinica Extensions site. This site will allow you to easily share useful tools, add-ons, and integrations you have built to make OpenClinica more useful. It will be a catalog of useful OpenClinica resources from around the globe. We’ll have more information in the coming weeks as this gets closer to launch.

Growing the Community

A recent discussion on the OpenClinica users mailing list centered around making OpenClinica more optimal for small, low-budget academic research studies, and how open source community participation is helping OpenClinica to meet those users’ needs.

Regarding OpenClinica’s target audience: OpenClinica is used in a tremendous variety of studies and organizations. Many of these are paying customers of OpenClinica LLC (f/k/a Akaza Research) who are running large GCP compliant, multi-site clinical trials. Clearly we as a company have an obligation and incentive to support them and provide software that fits their needs.

But I also am committed to making OpenClinica (the technology) successful and widely used. We want OpenClinica to power as many studies as possible, both small and large. If you’re determined to scratch down some data into Excel I won’t stop you. But since you’re reading this you likely know the arguments against doing so, and want a more robust solution for capturing and managing your clinical research data. We want lots of OpenClinica researchers, entrepreneurs and service providers to thrive in a growing ecosystem. If you are a researcher with no budget and you need OpenClinica to do X, me and my staff are ready and willing to prioritize getting feature X into a release if we have meaningful participation from community members to get that feature designed, coded, documented, tested, etc. Every participant in the OpenClinica community has the ability to make those contributions and/or to mobilize community participation to get their feature defined and developed. It’s not benevolence or volunteer work – with open source software the benefit you get out is proportional to the investment you put in.

There are growing examples of this participation. But more is needed to truly realize OpenClinica’s potential. As a community, we need to ask: (1) How do we grow participation? (2) How do we make it easier to participate? and (3) What can you contribute?

February 25th Deadline for Submitting Session and Poster Proposals for OpenClinica Conference

February 25th Deadline for Submitting Session and Poster Proposals for the 2011 OpenClinica Global Conference.

Share your experience and expertise by proposing a speaking session or poster at the upcoming 2011 OpenClinica Global Conference, May 8-9 in Boston.

The subject matter of posters and sessions may be either technical or non-technical and address a wide variety of OpenClinica related topics such as:
•    Case studies and best practices
•    Technical development strategies and techniques
•    Designing effective eCRFs
•    Open proposals to the community
•    Data and systems integration
•    Regulatory considerations
•    Tutorials / code sprints

Sessions and posters will be selected based on the following guidelines:
•    Relevance to the broader OpenClinica community
•    Interesting attributes (novel approaches, etc.)
•    Quality of abstract and credibility of author

Accepted poster and session presenters will be notified by March 11th.

If you have questions about submitting posters or session abstracts, please contact us.

The Early Bird Registration Deadline has also been extended through March 1st. Take advantage of this opportunity to lock-in discounted registration and training. More information at www.openclinicaconference.org.

The Open Source Effect: Akaza Research Provides Insight into Rapid Growth of OpenClinica

OpenClinica has seen a surge in usage over the past year, according to recent survey conducted by Akaza Research.

“Our annual survey of the OpenClinica community showed strong expansion in all key measurements of system usage,” said Cal Collins, Chief Executive Officer at Akaza. “In the past year we have seen doubling in the number of OpenClinica users and subjects, and a nearly 10-fold increase in regulatory submissions.”

The company reports that a reported 168,989 subjects have been involved in OpenClinica-powered clinical trials, a 224 percent increase from the prior year. In tandem, the company identified a 246 percent increase in the number of OpenClinica software users. The figure measures users working at the sponsor or CRO level and does not include users at clinical trial sites.

“Since these figures are based on a voluntary survey of the OpenClinica community, they are likely underestimates,” said Collins. “While it can be difficult to precisely measure the usage of freely distributed open source software, they provide a clear indication of the growth in OpenClinica adoption around the world,” he added.

The Professional Open Source Model

OpenClinica stands in stark contrast against the landscape of other EDC products that are provided under a closed source license. Akaza Research’s “professional open source” business model makes OpenClinica available in two editions. The OpenClinica Community Edition is freely available to use and modify, and may be downloaded form www.openclinica.org. The OpenClinica Enterprise Edition is a certified build of the open source technology commercially supported by Akaza Research. In many respects, the company’s business model is similar to that of RedHat (Linux), MySQL (database software), and other open source companies.

The OpenClinica rapidly growing open source community currently comprises over 10,500 users and developers, many of whom help review and adapt the open source software. Roughly 33 percent of OpenClinica users are located in North America, 30 percent in Europe, 14 percent in Asia, 9 percent in Africa, 7 percent in South America, and 7 percent in Australia. OpenClinica community members drive much of the product’s evolution, and in recent years have helped to usher the technology into a wide variety of clinical trial settings.

Worldwide Acceptance in Regulated Trials

The composition of the OpenClinica community is changing over time, with an increasing number of OpenClinica users representing commercial clinical trials. Currently, 55 percent of the OpenClinica community members identifies themselves as working in industry, with the remainder in academic or government settings.

According to Collins, “the robust overall growth is highlighted by an increasing proportion of OpenClinica users representing pharmaceutical, biotech, device, and other companies. We saw a 975 percent increase in OpenClinica-powered trials used in regulatory submissions in the past year, and in the next 12 months OpenClinica adopters expect to increase this number by another 200 percent. This is consistent with our OpenClinica Enterprise Edition customer growth, where a majority of new customers are from industry.”

For more information about OpenClinica see the OpenClinica website.

OpenClinica Community Virtual Forum

With over 8,000 members worldwide, OpenClinica is leading the charge on bringing professional quality open source software to the world of clinical trials. Many people within the OpenClinica community are interested in ways to influence the development of the electronic data capture and clinical data management system for their own purposes as well as for the greater benefit of the community. I want to briefly point out a little known, but powerful way to contribute by participating in the OpenClinica Community Virtual Forum.

The OpenClinica Community Virtual Forum is a bi-monthly web meeting of OpenClinica users who get together to provide input on new OpenClinica features and functionality and detail their experiences in working with the system. Meetings are kept small and intimate, and topics to the point. The Virtual Forum is oriented towards users of the system, not software programmers. Participants include data managers, study programmers, biostatisticians, and other users from a variety of organizations representing both the industry and academic worlds.

The exchange of ideas and feedback that has occurred in past Virtual Forums has significantly helped to refine the way functionality has been implemented and influence OpenClinica’s short and long term roadmap. In our most recent meeting last November, we discussed Dynamic Logic and received early feedback on the newly released OpenClinica 3.0.

The next Virtual Forum is scheduled for January 19th, 2010. If you would like to potentially participate in future Forum meetings, please send an email to community-forum@akazaresearch.com. For more information about the OpenClinica Virtual Forum, see https://www.openclinica.org/dokuwiki/doku.php?id=publicwiki:virtualforum:start.

OpenClinica Community and Enterprise Editions

Dear OpenClinica Community,

We are only hours away now from the general release of OpenClinica 3.0. There is a ton of excitement here at Akaza as we get ready to see many months of hard work come to fruition.

In advance of this milestone I’d like to describe a few changes we’re making to how OpenClinica is organized and how the name and logo can be used.

A brief background: As a founding member of the OpenClinica® open source community, I constantly strive to ensure that our technology has a reputation for meeting the highest standards of quality. The growth of OpenClinica® over the past few years is a testament to some success in that area. In my role as CEO at Akaza Research, a business that has invested millions of dollars into development of this open source technology, I recognize that the same reputation of quality is critical to our ongoing success. Part of how we maintain this reputation is to provide quality control over solutions that bear the OpenClinica® name. To enable this, Akaza Research owns the registered trademarks for OpenClinica® and Akaza and reserves the rights to their use.

With the release of 3.0, we are publishing a trademark policy on our website (also summarized below) that defines how the OpenClinica® and Akaza Research® trademarks may be used by members of the OpenClinica community. Our goal is to protect the quality of the OpenClinica® and Akaza brands without inhibiting the freedom that comes with the open source software model. These trademark terms complement the flexibility of open source licensing, by clarifying and creating confidence in the quality and reliability of solutions that bear the OpenClinica® name.

The most visible way the policy will be manifested is by separating the Community and Enterprise editions of the software. The default software download from OpenClinica.org is the Community Edition, pre-configured in a way that complies with the requirements of the trademark policy. The policy itself covers allowed uses of the trademarks for commercial and non-commercial purposes, both for modified (derivative) works and for unmodified versions of the software.

Akaza’s OpenClinica Enterprise customers and partners will be granted separate licenses that include additional permissions on how they may use the trademark in their marketing, operations, and services activities. Their installations will be distinguished as “OpenClinica Enterprise Edition” via the label in the footer of their OpenClinica pages.

I want to stress that 100% of the core OpenClinica source code remains free and under an open source software license. It is our promise that this will always be the case. Over time Akaza will offer additional proprietary services and technology offerings as part of the OpenClinica Enterprise Edition to complement this core, but it is our goal to ensure that the Community Edition always stands on its own as a fully-functioning, 100% open source EDC/CDMS platform.

I hope you share my view that this new policy will provide the clarity and confidence that allow OpenClinica to continue to thrive, without imposing undue restrictions on members of the community.

With that (too lengthy) introduction, here is a summary of the policy. Click here for the detailed, legal version:

CategoryDescriptionTerms and Conditions
OpenClinica Community EditionYou download and install the software on your own, and are not commercially supported by Akaza.You may not use the OpenClinica brand for marketing or sales purposes, and must include the community edition disclaimer.
OpenClinica Enterprise EditionYou are an OpenClinica Enterprise System Level Support subscribers. Other Akaza customers/partners and OpenClinica code contributors may meet the requirements of this category. Contact sales for more detail.Includes limited use of the OpenClinica brand for marketing and sales purposes, ongoing support, and display of “OpenClinica Enterprise Edition” in footer.
OpenClinica Community Edition – Derivative WorkYou download and install the software on your own, make modifications to the code, and are not commercially supported by Akaza. You want to keep the OpenClinica name/logo in the modified version.You may not use the OpenClinica brand for marketing or sales purposes, and must include the community edition disclaimer.. You must also clearly state the software has been modified and the modifications are not supported by Akaza.
Other Derivative WorksYou choose to strip out the references to the OpenClinica and Akaza names and logos from your modified version of the software. The trademark policy does not apply.The OpenClinica source code is licensed under the GNU Lesser General Public License (LGPL). You still must follow the terms of the LGPL, including copyright attribution and requirements for redistribution of source code. Of course, if you choose to follow this course, we hope you’ll also let us know about your software modifications and will contribute these back to the core repositories, both for the benefit of the community and to help ensuring future compatibility of your flavor of the software.

If you are a community user of a prior version of OpenClinica and do not intend to upgrade to the latest release, please contact us if you have questions about how the new policy may affect you.

Best Regards,

Cal Collins

CEO, Akaza Research