The OpenClinica Platform – Developer Round Table Discussions

OpenClinica is a clinical trial software platform that aims to provide data capture, data management, and operations management functionality to support human subjects-based research. It can be used for traditional clinical trials as well as a wide variety of other types of human subjects-based research.

Our vision for the product is to provide data capture, data management, and operations management functionality out-of-the-box, in an easily configurable, usable, and highly reliable manner. The underlying platform should be interoperable, modular, extensible, and familiar – so users can solve specific problems, in a generalizable way.

This past spring, the development team here at OpenClinica, LLC held a series of round table discussions about how this vision is reflected in the product. Our goals were to learn critical standards and information models needed for our technology to truly reflect this vision, to develop a consistent, shared vocabulary for the problem domain and the OpenClinica technology, and identify the most urgent opportunities to put these lessons into practice in the product and the community. In particular, we spent a lot of the time in these discussions about how OpenClinica’s use of the CDISC Operational Data Model helps enable this vision.

The discussions were invigorating and thought-provoking. We’ve recorded them to share with the greater community of OpenClinica developers, integrators, and others who want to better understand how the technology works, the design philosophy behind it, and where we’re going in the future. The videos are embedded below.

But before getting to the videos, here’s a bit more background on how we think about OpenClinica as a product and a platform.

First, OpenClinica functionality should be ready out-of-the-box, easily configurable and highly usable. Some of the most important features include:

  • Data definition and instrument/form design with no or minimal programming
  • Sophisticated data structures such as repeating items and item groups
  • Support for a wide variety of response types and data types (single select, multiple choice, free text, image)
  • Data management and review capabilities (including discrepancy management and clinical monitoring) with flexible workflows
  • ALCOA-compliant controls and audit history over all data and metadata, including electronic signature capabilities
  • Patient visit calendar design with management of multiple patient encounters and multi-form support
  • Reporting and data extract to a wide variety of formats (tab, SPSS, CDISC ODM)
  • Ability to combine electronic patient reported outcome (ePRO) data with clinically reported data using common form definitions (write once, run anywhere)
  • Deployment via multiple media, mobile or standard web browser

Many of these things have already been implemented, and more are under development.

The core concept around which OpenClinica is organized is the electronic case report form (CRF). In OpenClinica, a CRF is a resource that is essentially a bunch of metadata modeled in CDISC ODM with OpenClinica extensions. It doesn’t (necessarily) have to correspond to a physical or virtual form; it may represent a lab data set or something similar. An OpenClinica Event CRF is that same bunch of metadata populated with actual data about a particular study participant. Thus, it combines the metadata with the corresponding item (field) data, with references to the study subject, event definition, CRF version, and event ordinal that it pertains to. In this conceptual view of the world, CRFs (as well as CRF items, studies, study events, etc.) are resources with core, intrinsic properties and then some other metadata that has to do with how they are presented in a particular representation. Built around these core resources are all the workflow, reporting, API, security, and other mechanisms that allow OpenClinica to actually save you time and increase accuracy in your research.

Second, OpenClinica should be interoperable. The ultimate measure of interoperability is having shared, machine readable study protocol definitions, and robust, real-time, ALCOA-compliant exchange of clinical data and metadata that aligns with user’s business processes. It should be easy to plug in and pull out or mix-and-match different features, such as forms, rules, study definitions, report/export formats, and modules, to transport them across OpenClinica instances or interact with other applications. Establishing well defined methods and approaches for integration into existing health data environments is a key goal of interoperability.

Third, OpenClinica should be modular and extensible. OpenClinica already provides some of the most common data capture and data management components and aims to have a very broad selection of input types, rules, reports, data extracts, and workflows. However OpenClinica developers should also have the freedom to come up with their own twist on a workflow, module, or data review workflow and have it work easily and relatively seamlessly with the rest of OpenClinica. User identification, authentication, and authorization should be highly configurable and support commonly used general purpose technologies for user credentialing and single-sign-on (such as LDAP & OAuth).

The CRF-centric model allows us a great deal of flexibility and extensibility. We can support multiple modalities, with different representation metadata for rendering the same form, or perhaps the shared representation metadata but applied in a different way (i.e. web browser vs. mobile vs. import job). We can address any part of the CRF in an atomic, computable manner. This approach has been successfully applied in the Rule Designer, which takes the ODM study metadata and allows browsing of the study CRFs and items, with the ability to drag and drop those resources to form rule expressions. Features such as rules and report/export formats are represented as XML documents. These documents define how the features behave in standardized ways so that one rule can, say, be easily replaced with another rule without having to modify all the code that makes use of the rule.

Finally, OpenClinica aims to be familiar in the sense of allowing data managers, developers, statisticians to work in a design/configuration/programming environment that they already know. Programmers don’t all have the same experience, and it would be somewhat limiting to force OpenClinica developers to all use the same language (Java) that OpenClinica was written in. We are constantly looking at ways to make it possible (not to mention reliable and easy!) for users and developers to interact with and extend OpenClinica in a programmatic way. This can mean anything from data loading to more meaningful integrations of applications common to the clinical research environment. As proponents of open, standards-based interoperability, our starting point is always to develop interfaces for these interactions based on the most successful, open, and proven methods in the history of technology – namely the protocols that power the World Wide Web (such as HTTP, SSL, XML, OAuth 2.0). They are relatively simple, extensively documented, widely understood, and well-supported out of the box in a large number of programming and IT environments. On top of this foundation, we rely heavily on the wonderful work of CDISC and the CDISC ODM to model and represent the clinical research protocol and clinical data.

Session 1:  from 30-March-2012 (start at the 5 min 20 sec mark)

Session 2:  from 06-April-2012 (start at the 1 min 25 sec mark)

Session 2a:  from 20-April-2012

Session 3:  from 27-April-2012

Session 4:  from 11-May-2012

OpenClinica Exhibiting at DIA China Conference (May 20-23, Shanghai)

OpenClinica is exhibiting at the Drug Information Association’s 4th Annual China Meeting, May 20-23 at the Shanghai International Convention Center.

The environment for clinical research is rapidly evolving in China. This theme of this year’s event is “collaboration and innovation in China.” Sessions features numerous topics related to China and global pharmaceuticals.

Stop by the OpenClinica booth to learn about how OpenClinica is leading the way for modern, more effective clinical research in China.

OpenClinica at Society for Clinical Trials Annual Meeting (May 20-23, Miami)

OpenClinica will be both exhibiting and presenting at this year’s Society for Clinical Trials Annual Meeting, May 20-23 in Miami. Come by the OpenClinica booth to introduce yourself and learn about the many exciting things happening within the OpenClinica software and community! On Wednesday, May 23, OpenClinica’s, CEO, Cal Collins, will lead a presentation showcasing an innovative new OpenClinica mobile data capture technology. The session is titled “Electronic Patient Reported Data for Risk Screening in Primary Care Clinics using OpenClinica and CDISC ODM.”

OpenClinica Conference Showcases Innovation

Innovation in the OpenClinica community occurs on many different levels and in many places around the world. The 2012 OpenClinica Conference earlier this week brought together a diverse group of clinical and IT professionals to share first-hand a lot of the innovative, cutting-edge work being done within our community. Mobile, compliance, best practices, SAS, were all key themes at this year’s event. I was very encouraged by the growing enthusiasm for OpenClinica, and came a way more excited than ever about our collective ability to positively transform clinical research.

Here are some photos on Facebook: http://www.facebook.com/pages/2012-OpenClinica-Conference/228070113945322

Thanks to everyone for helping to make the 2012 OpenClinica Conference the best yet!

– Ben Baumann

Community OpenClinica Meetup in Vienna April 17th!

In the time leading up to the OpenClinica Global Conference, we are able to organize some small events outside of the USA.

We’d like to hold an informal meetup for all interested users of OpenClinica in Vienna Austria, April 17th 2012, 7pm-9pm, at the Starbucks Bräunerstraße. For a full address and map, please click here.

The agenda is currently open – we’d like for everyone to come with their own ideas, opinions and stories and be ready to share. From the OpenClinica LLC side, Tom Hickerson will be organizing the event, and if you have any questions or suggestions, please get in touch with him through thickerson -at- openclinica.com. You can also leave a comment below, or at our LinkedIn page!

Check Out the 2012 OpenClinica Conference Program

The program for the 2012 OpenClinica Global Conference is now available online (see it here). This year’s program features lots of useful content–key themes include:

  • Mobile (including mobile data collection, integration with mobile applications, etc.)
  • Integration/Interoperability (including web services, randomization, and more)
  • Using OpenClinica with SAS (perspectives, methods, and best practices)
  • Tutorials (including study build, installation/troubleshooting, data mining, performance management, and several other topics)
  • Case studies (including FISMA security, OpenClinica’s usage in the largest clinical research network in the world)
  • …and more!

The event also features hands-on exhibits demonstrating OpenClinica-related technologies. Finally, we are thrilled to have Dr. Tomasz Sablinksi deliver this year’s keynote address as he proposes a thought-provoking new “open source” model for clinical development.

The conference is April 22-23 in Boston. Space is limited so be sure to register today! And don’t forget to sign-up for post conference, system admin, developer, and user training!

– Ben Baumann

OpenClinica to be Used for European Commission Project “beta-JUDO”

As part of the European Union 7th Framework for Health, the “Beta-JUDO” project will involve hundreds of juveniles with obesity and type 2 diabetes. Pharmacology-based treatment strategies are limited for this growing patient group and the aim of the project is to identify novel strategies reducing insulin hyper secretion, which has so far not been considered a target for intervention in young obese individuals. The project will also involve beta-cell biology, brown adipocyte imaging, transcript and protein profiling, genetics, epidemiology and bioinformatics. A number of European institutions with expertise in these areas are thus involved. A kick-off for the project was recently held at Uppsala University, where about 30 expert scientists form several European countries attended. The project will continue until 2016 and has a total budget of €8 million.

OpenClinica will be used for data collection and data management across several European countries. The project is led by Professor Peter Bergsten Department of Medical Cell Biology at Uppsala University and two firms, Scandinavian CRO and e-Source Technology EMR, will be responsible for the management of the clinical part of the project.

We are proud to be involved in this prestigious project and to be able to demonstrate the abilities of OpenClinica and its powerful web services, which will facilitate the integration of external data from many sources across Europe.

– Dr. Krister Kristianson
e-Source Technology EMR

OpenClinica Conference: Early Bird Registration Ends Friday, February 17th

The chance to get discounted early bird rates on registration and training for the 2012 OpenClinica Global Conference ends this Friday, February 17th–so register today!

The 2012 OpenClinica Global Conference, April 22-23 in Boston, is a great opportunity to:

  • Learn what’s possible with open source EDC and the fastest growing clinical trials software
  • Hear case studies and best practices
  • Obtain ideas and techniques for how to better use OpenClinica
  • Acquire new skills through tutorials and training
  • Develop contacts with people who live and breathe OpenClinica

We are excited to have Dr. Tomasz Sablinski, founder and CEO of Transparency Life Sciences deliver this year’s keynote. His presentation titled “Breaking Barriers: Forging a New Model for Clinical Development” describes an innovative new “open source” model for clinical development. Truly innovative stuff!

The deadline for submitting session proposals, posters, and exhibits/demonstrations is also Feb. 17th.

Be sure to visit the OpenClinica Conference website, where you can register, view more information about the event program, and see pictures and videos from last year’s conference.

Breaking Barriers: Forging a New Model for Clinical Development

Could the principles of open source and open innovation transform the future of clinical research? Come hear thought leader and innovator Dr. Tomasz Sablinski deliver the keynote presentation titled “Breaking Barriers: Forging a New Model for Clinical Development” at the 2012 OpenClinica Conference on April 23rd in Boston.

The world has shown that it is possible to harness the power of crowds to deliver incredibly successful innovation and services (think Facebook, Wikipedia, Linux). However, this style of innovation is relatively absent within the domain of clinical research. Sablinski believes the time may be ripe to borrow from the principles of open source and telemedicine in order to create a new, more effective model for clinical development.

Dr. Sablinski’s ideas have profound implications. However, while bold and thought provoking, they are more than academic. He puts his money where his mouth is–Sablinski’s start-up company, Transparency Life Sciences, has set out  to increase the efficiency of clinical development leveraging open principles that turn much of the current way of thinking on its head.

Dr. Sablisnki’s assessments of the current state of clinical development are based on over 30 years in the field, as a practicing physician, basic researcher, drug developer, investor,  and now, entrepreneur. He has served as a researcher at Harvard Medical School, a Medical Director at Parexel, VP of Clinical Development at Novartis, and Head of Development and Managing Director at private equity firm Celtic Therapeutics.

We look forward to hosting Dr. Sablinski at this year’s OpenClinica Global Conference!

– Ben Baumann
Chair, OpenClinica Conference Committee

Attend the 2012 OpenClinica Conference!

The 3rd annual OpenClinica Global Conference will be held in Boston, MA on April 22nd– 23rd. Kicking-off the event with our hosted pre-conference social gathering on Sunday night and join us Monday to learn about OpenClinica and network with the community. The conference will feature tech demos, session presentations, case studies, tutorials, poster presentations, and more!

Sign-up now to take advantage of the discounted early bird prices for conference registration and training courses. We are now accepting submissions for speaking sessions, technology demos, and posters. For more information visit https://community.openclinica.com/conference.