2015 Future of Open Source Survey Results

Open source software has emerged as the driving force of technology innovation, from cloud and big data to social media and mobile. The Future of Open Source Survey is an annual assessment of open source industry trends that drives broad industry discussion around key issues for new and established software-related organizations and the open source community.

The results from the 2015 Future of Open Source Survey reflect the increasing adoption of open source and highlight the abundance of organizations participating in the open source community. Open source continues to speed innovation, disrupt industries, and improve productivity; however, a reported lack of formal company policies and processes around its consumption points to a need for OSS management and security practices to catch up with this growth in investment and use.

Check out the slides below for survey results.

Reducing friction in patient engagement: an (unconventional) case study

Participate_SCDM_SurveyOur quest for frictionless, electronic patient reported outcomes (ePRO) data capture has us looking for novel ways to engage patients and streamline process. I’d like to share a fun and interesting example of this work, in which we used Participate (the OpenClinica ePRO solution) to engage study subjects at the recent SCDM annual conference.

Our goal at the SCDM conference was to get as many attendees to try OpenClinica Participate as possible. With the vast array of vendors, eye candy, and giveaways, it’s a big challenge to cut through the noise and offer a simple, fun way to engage an audience. The same holds true when engaging patients. With the enormous number of daily distractions, ensuring that your patients can quickly access, fill out and submit well-constructed, simple forms is key to compliance and ultimately, better data.

I built the form, shown here, in OpenClinica and enabled access to it via a custom URL, a new feature in our latest release.

Attendees filled out the form, sprinkled with fun health habit questions, then captured information to allow us to draw their names to win Fitbits and other giveaways. We were able to use this data and update our graphs to give the participant a view of how they stacked up with their peers—cool!

Imagine if patients could view a visual representation of the study they are enrolled in – see the parallels and possibilities?

Graphs_SCDM

Who says ePRO and patient engagement can’t be fun?

Automatic Event Scheduling with OpenClinica 3.3

An exciting new feature that has been at the top of the request list is Event Scheduling. Using the flexible and powerful Rules Designer in version 3.3, you can now build rules to automatically schedule events.

There are several workflow methods which offer a customized way of handling your study calendar.

Method 1 – Manual Reschedule

In Method 1, a series of study events can be scheduled at once off a given event date.  Any subsequent changes to event dates will not be automatically rescheduled. You can use arithmetic to generate future event dates (e.g. Visit 2 date = Visit 1 + 7).  OpenClinica also supports use of static dates and the system’s “current date” variable.

MethodOne

Method 2 – Auto Reschedule

In Method 2, a given event date generates all future visits and any changes to an event date in the chain will automatically update subsequent event dates.

MethodTwo

Method 3 – Auto Reschedule Based on Event Status

OpenClinica also allows you to write EventAction rules using the event STATUS. This opens the door to more calendaring power! Here, you can schedule an Event based on the status of another Event. For example, if a critical visit is skipped the system can auto-schedule the End of Study visit. Or let’s say you only want the next event to be scheduled when the current event is “Completed” (or “Started”). This is all possible–it’s really up to you.

MethodThree

Rule Designer Example

See the following example of scheduling the next event with Rule Designer.

EventActions_Rules

If you haven’t heard, the OpenClinica Rule Designer is now freely available. See http://wp.me/p6ydw-rE for more details.
Learn more about Event Scheduling with Rule Designer HERE.

OC Innovation Award & Community Catalyst Award Announced

A big thanks to all the folks who helped make OC14 on June 22 & 23 a smashing success! We had engaging workshops on Sunday and a developer meet-up co-facilitated by @albertk and @kkrikor. Monday delivered a fantastic line-up sessions and demos which highlighted a lot of the exciting innovation that’s taking place in the OpenClinica community. To give you a glimpse of these sessions, we will post the session slides online soon.

At the end of the day on Monday, Cal Collins presented two newly created awards recognizing individual contributors to both our community and our software. These awards were determined based on the community’s feedback and nominations. Huge thanks and appreciation goes out to these gentlemen for their great work and selfless contributions to the community.

Congratulations to Gerben and Lindsay—this recognition is well deserved!

And special thanks to numerous others who have have done amazing work with OpenClinica. Here’s to ongoing community collaboration that will continue to deliver innovations that will make OpenClinica even more of a uniquely impactful tool for clinical research.

OC14_199Some of the attendees at OC14 at the Exchange Conference Center in Boston.

Validating Open Source eClinical Systems

Validating software you use in clinical research is a requirement of most regulatory authorities, such as the FDA under 21 CFR Part 11. It’s also generally considered a good practice that ensures a system adequately meets your needs. However, validating software can be a confusing topic to many. Validation WP

In her white paper, “Validating Open Source eClinical Systems” validation expert, Laura Keita, articulates the validation process and responsibilities, and simplifies the principles of validation by focusing on the core mantra: “plan it, do it, prove it.” The paper also looks at validation strategies for open source eclinical software, and how the FDA has acknowledged the impact the open source model has on improved software quality—all part of the spirit of validation.

OpenClinica Central User Training – Feb 24-27 – Waltham, MA

Don’t miss OpenClinica’s Central User training course in Waltham, MA, February 24-27!

Register now, seats are filling up!

Register for Training

About the course:

Our most popular course, OpenClinica “Central User” Training delivers a 4-day intensive experience for people who need to learn about using OpenClinica from all types of user perspectives. This course is ideal for someone who wants to become an OpenClinica super user or will be responsible for training/teaching/supporting their colleagues. Classes are highly interactive and incorporate exercises and tailored instruction. We also regularly organize private classes as needed.

Register at:

https://www.openclinica.com/open-enrollment-training

We hope to see you in Waltham!

Warm Regards,
The OpenClinica Team

EDC Scandinavia uses OpenClinica for BYOD ePRO

Krister Kristianson, PhD.
EDC Scandinavia AB, Stockholm

RESTful web services with OpenClinicaIn a recent study involving several hundreds patients, we decided to offer patients the ability to collect their diary data using their own smart phones instead of the traditional paper diary. The patients who decided to participate in the study downloaded the app to their smart phone or could use their desktop to access the application.

The apps were developed for iPhones and Androids with a reminder function that notified them when to report their symptoms. The data was then transferred to OpenClinica using the RESTful web services immediately upon entry. The patients ID and pin code were tested before data was added to the database to avoid any illegitimate entries.

About 80% of the patients decided to use the electronic diary – 65% using iPhones and 35% using various Android devices. They could also download the app to iPads or other tablets and if they preferred, they could use the application on desktops.

Outcomes:

  • Paper CRFsOf the patients who used the traditional method of reporting diary data on paper, 2.5 times more patients failed to report at scheduled time points compared to the patients using the app.
  • The app recorded the date and time automatically. When using paper, you can never be sure that the diary has not been completed at the time listed.
  • The addition of simple edit checks mitigated data entry errors, greatly contributing to the increased quality of the data.
  • It further reduced the manpower needed to manually enter data on to the eCRF and enabled us to monitor the patients in real-time and contact them if anything went wrong.

Although the patient population was relatively young, in this part of the world, even elderly patients are likely to use smart phones or desktops and would to be willing to use electronic data capture (EDC) for reporting diary data. The easy configuration of web services in OpenClinica and the ability to query data upon arrival made it an easy task to set up and validate the study.

OpenClinica at Netherlands CTMM Annual Event

ctmm_AnnualmeetingOn September 12, 2013, The Center for Translational Molecular Medicine (CTMM) held their annual meeting at the Media Plaza, Jaarbeurs Utrecht in the Netherlands. The theme,  ‘Let’s talk about Value,’ celebrated the implementation of proven results in a clinical practice, the benefits they will bring for patients, and the real value they will add to society and the Dutch economy. The presentations covered all the angles from basic research to implementation in today’s healthcare environment, giving you a unique perspective on end-to-end translational research and its societal and economic impact.

CTMM’s Translational Research IT (TraIT) group, an OpenClinica partner, held a presentation entitled, tranSMART, the TraIT road towards data integration and sustainability. Kees van Bochove (The Hyve) and Remond Fijneman (VUmc) discussed the phenomenal size of the datasets produced in research programs and their distribution over different research laboratories and clinics. These require an informatics infrastructure that allows for a seamless integration and exchange of large amounts of data as well as for complex data analysis. They also discussed the use of OpenClinica’s EDC | CDMS system and how it has enabled the aggregation of much of the data  and the extensibility, through web services, to handle all the unique areas of medicine supported by CTMM.

Back from the OpenClinica German Users Group Meeting

Loebe_900Last month, OpenClinica users throughout Germany converged in Berlin for the very first German OpenClinica Users Group Workshop entitled: OpenClinica – an Open-Source Clinical Data Management System for Clinical and Translational Research. This was held at the TMF (Technology, Methods, and Infrastructure for Networked Medical Research) facility.

Brought about by the efforts of Matthias Löbe, the goals of the workshop were to gain experience, insight, and give back to the strong community of OpenClinica users in Germany. Löbe offered the following insight when asked about his motivations for organizing this group:

“It turns out that there are many locations throughout Germany with OpenClinica experience along with many developing adaptations or extensions. But so far, none of the 70 registered workshop participants knew of the activities carried out by others. The workshop has opened a whole new perspective.”

Goodwin_900My colleague, Alicia Goodwin, who has been working with OpenClinica since 2007, was invited to speak at the conference. I interviewed Alicia after she returned to share insight on the event. 

What were you looking forward to the most at the workshop?
I really wanted to meet the OpenClinica users and learn about how OpenClinica is used in Germany. The workshop had about 70 participants, representing seasoned users and developers to clinical site personnel looking for more information. There are several very active and brilliant OpenClinica community members in Germany, such as Mattias, Gerben Rienk, Philipp Leusmann, Henrik Dittman, Christian Hänsel, to name just a few. I was excited to hear about the wide range of work they are involved with.

Was the entire workshop spoken in German?
Yes, it was. Thankfully, I have enough of the language experience that I was able to understand most of what was being said.

You were invited to speak at the workshop. What was your talk about?
I spoke about the vital users and developers in our community and their role in OpenClinica development, innovation, and global support. I also talked about some of the development tools that are used. JIRA was a big topic as it really underscores our commitment to transparency, our rigorous SDLC, and our open source ecosystem.

What kind of technical information or issues were discussed?
A key theme was around the value that could be obtained from increasing portability and scalability extending th RESTFUL APIs and reusing study elements such as OIDs, rules, metadata across multiple systems. Essentially, looking at architecture in the future.

Was there anything that surprised you at the workshop?
One of the really cool things that I saw was a project called OpenClinica Big Data, developed by Dr. Thomas Deserno from Aachen University. OpenClinica Big Data is an OpenClinica extension specifically designed to handle some of the unique challenges associated with uploading and managing large image file sets. The system utilizes OpenClinica web services, allowing users to make calls from OpenClinica to retrieve image data from the Big Data repository. This module enriches OpenClinica with a convenient and context-related transfer of binary large objects (blobs), such as biomedical images or signals.

I was also very impressed with the overall enthusiasm and turn-out. Hopefully this initial workshop will encourage ongoing interaction among German-speaking OpenClinica users.

© TMF – Images property of TMF

Calling all OpenClinica Users – 2013 Usage Survey

We need your help! To effectively gather information on the worldwide use of the OpenClinica software platform, your input is crucial. Please take this very short survey and we will donate $2, on your behalf, to the St. Jude Children’s Research Hospital. We will share the level of support for St. Jude’s after we wrap up.

TakeSurvey

Thank you for representing the growing OpenClinica community and for your part in making the world a healthier place.
» Rob