OC15 in Review

Two weeks ago, members of the OpenClinica community converged on the Lloyd Hotel in Amsterdam for the 2015 OpenClinica Global Conference. The event was highlighted by a keynote from John Wilbanks, who inspired us with a great talk on how mobile technology and open source can help break new ground in understanding disease. Smartphone-based engagement tools, used in real world settings, can enable greater participation in research, cut costs, and make new research designs and insights possible. It’s not just theoretical, as his company, Sage BioNetworks, is walking the walk by open-sourcing its e-consent toolkit and working with Apple on studies using ResearchKit.

Our community demonstrated it is also a powerful driver of innovation. Through innovative applications, by integrating with other powerful tools, or augmenting the OpenClinica core with custom built extensions, OpenClinica is playing a role in patient engagement, big data, and translational science. TraIT shared its work integrating OpenClinica into a Translational Molecular Medicine infrastructure (ppt), Aachen University presented its integration of medical imaging applications, and University of Cambridge’s RDCIT team unveiled its integration sophisticated pedigree and phenotyping capabilities to support clinical genomics research (pdf). We got to take deep dives into powerful GUIs for data import, client libraries for OC’s web services API, and data marts/reporting. That’s just a few. Many of these efforts are open source and are being shared freely–a phenomenon unique in the field of clinical research.

https://twitter.com/RRittberg/status/604983558562820096/photo/1

https://twitter.com/benbaumann/status/604925177584087040/photo/1

We have become a community that rapidly disseminates ideas and code while holding each other to rigorous standards of quality. We are building on a shared foundation of strong data provenance, audit trails, privacy protections, and GCP compliance. OC15 was a reminder of how openly and effectively our community collaborates, and how great we are at welcoming new participants. I left OC15 inspired and motivated by the participants’ passion and creativity.

Engineering OpenClinica’s Future

We recently introduced OpenClinica Participate™.

We believe all research participants—patients, clinicians, researchers, should have technology that meets the ‘anytime, anywhere’ expectations of a mobile, smartphone enabled world. Based on conversations with the OpenClinica community, many of you share this view as well. We are committed to making sure, at minimum, that OpenClinica’s patient engagement technology ‘just works’ in mobile, real world environments. Wherever possible, we will go beyond that and work to make the participant experience engaging, fun, and inspiring.

As transformational as these patient engagement capabilities can be, what we’ve been working on is about more than that. This is about a foundation for the future of the OpenClinica project.

EnketoAs I briefly pointed out in an earlier post, OpenClinica Participate forms are powered by the new enketo-express app that was built around the widely used enketo-core form engine (both available on GitHub).

OpenROSA_LogoOpenClinica will soon natively support the OpenRosa API, which will let you run Enketo, ODK Collect, or any of a number of OpenRosa-compliant data capture clients. Eventually, we envision the Enketo forms engine will replace the current CRF engine in the OpenClinica code base.

odk_medium_squareIf you’re not familiar with Enketo, ODK, or OpenRosa, here’s a primer. Most important is understanding there is a rich global ecosystem of technology, developers and users around the OpenRosa Xform standard. The resultant solutions have been battle tested in diverse health care and field-based data collection settings over many years. In keeping with the open source principles of flexibility and choice, aligning the OpenClinica ecosystem with this community will provide new features and options that you can use.

As my 5 year-old son has taught me when we watch Spider-Man cartoons, with great power comes great responsibility. So it is with open source software. Tapping in to the richness and variety of the OpenRosa community creates new possibilities, but it can add complexity too by expanding the options you have to choose from. OpenClinica is released under an open source license so that many developers can improve, combine, and share their code in a way that enhances quality, usability, and features, and we believe that this richness will drive the next cycle of innovation.

With this goal of better encouraging code contributions, the focus of the repositories and downloads will be easy-to-use open-source libraries: building blocks for developers to create their own OpenClinica-powered apps and modules.

If you are developing on the OpenClinica code base to add features or build custom solutions, you’ll have a greater ability to mix and match just the pieces you need, and to share back your improvements in a modular fashion. It will be much easier for developers to use the libraries and share their experience and contributions back with the community. We will gladly help out if you experience issues. Our own engineers will be able to focus more of their time on improving quality, usability, and functionality, rather than on packaging, testing, and supporting so many different environments. We hope to build a strong collaboration with the Enketo and OpenRosa communities that spawns new ideas and developments.

So try it out! Check out OpenClinica Participate or get started by hooking up OpenClinica with Enketo.

And need I say, you’ll certainly be able to learn more about these OpenClinica innovations at the upcoming OC15 conference in Amsterdam, May 31-June 1.

Reacting to #ResearchKit

OpenClinica_AppleRK Apple, Inc. has a remarkable ability to capture the world’s attention when announcing “the next big thing.” They have honed their well-known Reality Distortion Field skills for over 30 years. As the largest company in the world, and bellwether of the technology industry, Apple’s announcements are immediately recounted, opined, lionized, and criticized all across the Internet—sometimes with very limited real information on the new product itself. Of course, it helps to have their unmatched track record in actually delivering the next big thing.

ResearchKit has grabbed such attention. Maybe not as much as The Watch, but amongst the minority of us who pay attention to such things. And the reactions have been typically polarized—it’s either an “ethics quagmire” or “Apple fixing the world.”

But reality rarely presents an either-or proposition. I’ve written before on the need to use technology in simple, scalable ways to engage more participants in research and capture more data. Every form of engaging with patients and conducting research is fraught with potential for bias, bad data, and ethical dilemmas. Properly controlling these factors is difficult, and the current handling of these factors lead many to conclude that clinical research is overly “bloated and highly controlled”. There’s truth to that, but the fundamental need for good controls is real. As technology enables us to engage in new ways, how we implement such controls is likely to transform, perhaps unrecognizably so.

I don’t think Apple—or anybody—has these problems fully solved yet. And I expect we’re going to a see a vigorous debate in coming years between #bigdata and #cleandata that I hope will lead us to more of both. But ResearchKit, or at least the announcement thereof, is a game changer. Whether or not ResearchKit in its present form becomes a widely adopted platform, the impact was felt overnight: “11,000 iPhone owners signed up for a heart health study using Apple’s newly-announced ResearchKit in the first 24 hours… To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country”. ResearchKit builds on momentum towards patient-centricity established in the last five years within pharma, NIH, online patient communities, mHealth, and health care, and uses Apple’s consumer clout to bring it to the attention of the average person on the street.

So let’s break down what we know about ResearchKit. Since this is a blog about OpenClinica, we’ll also share early thoughts on how we see OpenClinica, ResearchKit, and OpenClinica Participate fitting together.

It’s Open Source. Great move! We’ll learn more about what this means when the code is released next month.

The technical paper indicates it is a front-end software framework for research, and that they expect it to expand over time as modules are contributed by researchers. Through use of both platforms’ APIs, OpenClinica could serve as a powerful backend and ‘brain’ to ResearchKit.

It’s not clear if data goes through Apple’s servers on its way to a final destination. I also haven’t seen anything from Apple mentioning if it will be portable to other non-iOS platforms (which represent 80% of mobile device market share), though its open source nature would suggest that will be possible.

Surveys. Analogous in many ways to the forms module in OpenClinica Participate, it is a pre-built user interface for question and answer surveys. As somebody who’s worked in this realm for years, I know that this can mean a lot of things. What specific features are supported, how flexible is it, how easy is the build process? Perhaps most important, can it be ported to other mobile app platforms, or to the web?

Informed Consent. The need for fundamental ethical controls for for research conduct and data use are just as important in the virtual world as they are in the brick-and-mortar realm, and Informed Consent is a cornerstone. I’m glad to see ResearchKit taking this on; I don’t expect they have it 100% figured out, but their work with Sage Bionetworks, who has released an open toolkit on Participant Centered Consent, is a great sign.

Active Tasks. Maybe the most exciting component, here’s where ResearchKit takes advantage of the powerful sensors and hardware in the device and provides a way to build interactive tests and activities. In this way, I expect ResearchKit will be a great complementary/alternative frontend to OpenClinica Participate when specialized tests tied to specific, highly-calibrated devices are required.

In general, the promise is big: that technology will lower barriers in a way that leads to fundamental advances in our understanding of human health and breakthrough treatments. That we’ll go from data collected once every three months to once every second, and we’ll encounter–and solve–problems of selection bias, identity management, privacy, and more along the way. And that, according to John Wilbanks at Sage, “there’s coming a day when you’re not going to have an excuse to have a tiny cohort just because you chose not the use digital technologies to engage people.”

Introducing OpenClinica Participate

In clinical research, we all work towards better evidence-based, patient-centered health interventions. We all understand the importance of evidence. But how about patient-centered? We hear this phrase perhaps too often nowadays, but it’s more than just a buzzword. A patient-centered approach directs research toward questions that are important to patients so they can make more informed healthcare decisions. It measures the outcomes that are noticeable and important to patients, and produces results that help them weigh the value of healthcare.

At OpenClinica, we think increasing the patient-centeredness of research is vital. Industry, NIH, FDA, and the general public seem to agree, and furthermore share our view that technology can increase patient engagement. This can happen by designing highly accessible, mobile technology to:

  • Improve patient participation, motivation, and adherence
  • Increase ability to meet recruitment goals, budget, and completion timelines
  • Enable new designs that better target populations and/or more closely align with real-world use

HTCPhoneI’d like to introduce our upcoming product, OpenClinica Participate, a tool tightly integrated with OpenClinica for engaging patients and collecting data directly from study participants.

If you took our recent survey, you got a glimpse of what your forms for patient-reported outcomes could look like in OpenClinica Participate. Driven by a powerful forms engine based on proven open-source technology, the participant forms are simple, dynamic, mobile-focused, and platform-independent.

But it’s about a lot more than mobile-friendly forms. Patient expectations are rising while trial participation is shrinking. Clinical trials need to engage ‘Subjects’ as ‘Participants’ — by recruiting and retaining through real-time engagement and meeting the ‘anytime, anywhere’ expectations of a mobile, smartphone enabled world. It starts with an intuitive, action-oriented dashboard. Participants are greeted with a simple interface that motivates and focuses them on what they need to do today. The layout is responsive and knows whether you are using your phone, a tablet, or a traditional browser. Communication with the participant can occur through multiple channels — via the dashboard, through SMS, or via email, with options to help you make sure the right balance is struck between security and accessibility.

Participate_OCUILast, and perhaps most important, Participate is tightly integrated with the OpenClinica EDC platform. The Participate solution allows you to design your study and forms using the OpenClinica study build tools you already know, while seamlessly capturing all your clinical and participant-reported outcomes in a single database. You can build skip patterns, repeats, and other logic into your participant forms just as you do with traditional OpenClinica CRFs, using the same rules engine. You can use scheduling rules to identify the next time participant feedback is required. As data is submitted by study participants, their activities become part of the same audit trail that tracks what your clinical users do. The data they submit can immediately be reviewed and extracted along with CRF data from other sources.

Participate is extremely easy to adopt. As a modular add-on to your hosted OpenClinica Enterprise instance, it can be activated for any new study from within your study build screen. Forms are powered by the widely used open source enketo-express library and all editions of OpenClinica will support the widely-used OpenRosa API to let you run Enketo, ODK Collect, or any of a number of OpenRosa-compliant data capture clients. Participate utilizes a cloud-based Software-as-a-Service (SaaS) delivery model, so there is no costly and delay-inducing software deployment to worry about.

 

Visit the OpenClinica Participate Website

 

Using Tokens in OpenClinica CRFs and URLs

An important new feature in OpenClinica 3.3 is the ability to incorporate variables in your CRF display. When designing your CRF, you can embed tokens into your form design with some simple markup (such as ${studySubject} to print the Study Subject ID). When the CRF is rendered for a patient visit, the tokens are parsed and replaced with the appropriate values. So, if you now want to display the name of the study, visit name or number, or study subject ID on a particular place on the form, you merely need to insert the token in the right place. You can even display the value of an item – for instance if you want to display a value entered in section 1 on a later section of the form, just use ${item[‘item_name’]}, replacing item_name with the name of your item. (screenshot right-justified – overlay snippet of CRF w/token on top of snippet of LI text with parsed variable)

ParameterizedLink2

This feature can be used in much more powerful ways too, especially when combined with the existing ability to include HTML markup and javascript code in your CRF.

In addition, tokens can be embedded as parameters in a link to an external system, such as an imaging or genomic data store. With the use of parameters specific to the study subject and event CRF, the link can take the user directly to the relevant record in the external system. With a little bit of clever javascript, the form could even embed the image or other media directly. You’ll have to set up appropriate security rules in the external system to allow this, and ensure the two systems share the same identifiers. (screenshot of embedded image)

The design, coding, and testing of this feature has been developed in collaboration with our fantastic partners at CTMM/TraIT in the Netherlands. With them, we have been able to build a feature that will fulfill a key need of theirs (link directly to a patient image at point of data entry). With the feedback of others in the community we’ve been able to make it generalizable for a far broader set of capabilities, adding to OpenClinica’s powerful existing API and extensibility while keeping it simple and familiar.

Read more here.

OpenClinica Rule Designer Now Open Source

I’m excited to announce that the OpenClinica Rule Designer module is now freely available to all OpenClinica Community Edition users, and the source code is open to developers.

With this tool, users can more easily create powerful and advanced rules, driving productivity. With the upcoming release of rules-based event scheduling it is a great time to open up this valuable, time-tested tool. You can request access to the hosted Rule Designer for your Community Edition instance here.

Up until now, the Rule Designer has been available only to users of the OpenClinica Enterprise Edition. We are always looking to reduce hurdles to increasing the adoption, development, and innovation of OpenClinica, and being more open is almost always the best way to do this. Making the Rule Designer open source and freely available encourages feedback and contributions that make it better for everyone, and enables innovative re-use of parts of the code.

If you are an Enterprise Edition subscriber, nothing will change, and you’ll continue to have fully supported access to your Rule Designer backed by our Service Level Agreement.

OpenClinica is already a highly successful community project. Tens of thousands of community members use the technology and many share their innovations, create extensions, write documentation, help beginners, translate, and contribute code to the core software. Now developers interested in advanced study design capabilities can join the party, too!

Here are a few parts of the Rule Designer code that are worthy of note:

– Tree model of an OpenClinica study with 3 views – by CRF, by CRF Version, by Event Definition
– Drag-and-drop rule design functionality
– Use of the REST API to interact with OpenClinica core
– Use of OAuth to authenticate with OpenClinica to use the REST API

Get the source code on GitHub (LGPL license). Technical information on how Rule Designer works and interacts with OpenClinica is here.

There will be some great information about the Rule Designer and the new calendaring features at the upcoming OC14 conference. Long time OpenClinica expert Alicia Goodwin will facilitate a workshop on “Rules for Advanced Users,” providing a deep dive into OpenClinica Rules, a powerful mechanism for adding workflow, edit checks, and other capabilities to your OpenClinica study. She will also be showing the latest innovation of Rules-based calendaring features. More here.

OC14Logo250x260

The Future of Open Source

It was a privilege for OpenClinica to help with the “Future of Open Source” survey recently completed by Michael Skok of North Bridge Ventures, Black Duck and Forrester. The survey polled users and other stakeholders across the entire spectrum of OSS.

Recently published results from the survey substantiate the idea that open source is ‘eating the software world’s lunch’ (to borrow a phrase from Michael). OSS powers innovation, increases security, and enables a virtuous cycle of proliferation and participation across major sectors of our economy. This is even true in healthcare and life sciences, and we are seeing these trends within OpenClinica community. People are adopting OpenClinica and other open source research technologies because of the quality, flexibility, and security they provide, not just to save a buck or two.

What I find particularly significant in the results is the increased recognition of quality as a key driver of adopting open source. 8 out of 10 survey respondents indicate quality as a factor for increased OSS adoption. This has vaulted from the #5 factor in the 2011 survey to #1. In research, quality and integrity of data are paramount. OpenClinica’s active (and vocal!) community’s constant scrutiny of the code, and continuous improvements demonstrate the power of the open source model in producing quality software. Furthermore, working in a regulated environment means you need to do more than just have quality technology. You also must provide documented evidence of its quality and know how to implement it reliably. The transparent development practices of open source are huge contributors to achieving the quality and reliability that clinical trials platforms require. Knowing that feature requests and bug reports are all publicly reported, tracked, and commentable means nothing can hide under the rug. A public source code respository provides a history of all changes to a piece of code. And of course, it greatly helps that many of the key tools and infrastructure that power open source projects are open source themselves.

That’s just one set of factors driving us to a more open, participatory future:

“As a result of all this, Open Source is enjoying a grassroots-led proliferation that starts with a growing number of new developers and extends through the vendors and enterprises to the applications and services, industries and verticals, reaching more people and things in our everyday lives than ever before… there are now over 1 million open source projects with over 100 billion lines of code and 10 million people contributing.”

One thing I predict we’ll see a lot more of in the next year, especially for OpenClinica and life sciences as a whole, is greater interaction between projects and communities. OSS reduces traditional barriers and lets more people ‘get their hands dirty’ with tools and technologies. As OSS tools, libraries, and apps proliferate, innovation will increasingly come from the mashups of these projects.

Follow the survey findings and updates @FutureofOSS and #FutureOSS  

Responding to Heartbleed

Please change your OpenClinica passwords.

By now you’ve probably heard about the Heartbleed web security bug. At OpenClinica we take the security and integrity of our users’ data very seriously. We have been hard at work over the past 3 days responding to this vulnerability.

Our team worked into the wee hours the past two nights to respond to the problem, and I’m proud to say we have fully patched the vulnerability for all our OpenClinica Enterprise Optimized Hosting customers. If you run an OpenClinica Community instance, please check and patch your system as soon as possible. The vulnerability is at the certificate/server level, so there’s no new version of OpenClinica to install. The exact steps to update will depend on the environment you’re running on. We’ll provide some more information and references shortly. Here’s what you can do:

  • Check your site for vulnerability, using a checker such as https://lastpass.com/heartbleed/.
  • Update your server to current OS patch levels, including applying OpenSSL updates where applicable.
  • Generate a new key and SSL certificate for your domain, and deploy the new key and certificate to the server.
  • Check again via https://lastpass.com/heartbleed/ to confirm vulnerability is patched.
  • Have all users update their passwords.

 

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.

The Open Source Way

The OpenClinica LLC team subscribes to a core set of values we do our best to live and work by in everything we do. They are primarily based around what it means to us to be open source. In the spirit of living by the first one (be radically open), here they are!

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At OpenClinica, we believe that a successful business depends on a successful and growing open source community. We aspire to be part of a community that is as accomplished as Linux, Drupal, and Apache. We want to achieve a similar level of innovation, quality, collaboration, and transparency. To travel this journey (and build a great product along the way!) we constantly strive to put in practice the following values:

  • Be radically open.
  • Release early and often. Not always production releases, but find ways to get code in the hands of users and testers.
  • With enough eyeballs, all bugs are shallow. Follows from release early and often.
  • Keep barriers low!! For distribution, evaluation, adoption, contribution. Question complexity. Some is necessary but favor simplicity where at all possible.
  • If you need it, then build it. Or find it (see next one).
  • Share and re-use other’s work. Avoid not-invented-here (NIH) syndrome. Somebody has done it before. Or, someone has done something similar but not thought of using it for what you need. Here’s where radical innovation and gigantic leaps forward happen.
  • Keep at it. There are no substitutes for persistence and perspiration.
  • Reward good ideas and good contributions. Let leadership and accountability thrive.
  • Maximize participants’ strengths.
  • Avoid community anti-patterns.
  • Make it yours. You are your personality.
  • Most of all, find your passion and let your love for what you do shine through!

There are hundreds, if not thousands of articles, presentations, and academic papers on what makes open source communities work. Here are a few that best articulate the values described above:

Eric Raymond, The Cathedral and the Bazaar. It all started here. Read the summary or the full paper.
Matthew Mascord, How to Build an Open Source Community
Joel Dietz, How to build a vibrant open source community
David Neary, Open Source community building: a guide to getting it right
Jonathan Corbet, How to destroy your community
David Nalley, Leadership in open source communities
Stephen Walli, Open Source: No one is working for free
Ben Baumann, OpenClinica Community Surpasses 10,000 Members …and oh yeah, what is this open source thing?