New OpenClinica Developer Release: Revamped Print Module

A new developer release is available for OpenClinica. While it contains a number of significant improvements, one of the more fundamental changes is a reconstruction of OpenClinica’s print CRF functionality. To date, all printable screens resembled the existing web form interface for the eCRF, whereas now, this engine has been completely redesigned to more closely follow industry standard for printable views of web forms.

Why This Matters To Developers

Ok, I get it. You are a developer, so what’s the big deal about being able to send CRFs to the printer?  It is the technology behind this improvement that will hopefully catch your attention. Important changes have been occurring in the sphere of web apps, and I don’t mean just a sprinkling of AJAX here and there along with a UI that looks like Facebook. The real revolution goes much deeper.

Setting a precedent for OpenClinica: Completely Decoupled Client Technology using Web Services

The notion is simple. Create a browser-based client with the same decoupled technology that a iOS or Android mobile client requires. In plain English, this means that only data is sent back and forth between the client and the server. Just as is expected with a native OS mobile client, the browser-based client never relies on the server to generate or send any part of itself except when the URL is first accessed and loaded into the browser. The client is therefore completely decoupled and can be in complete control of their own state. This results in a more reliable, speedier, feature-packed, and easier to maintain platform for both the client and server. Another way to put it … in the not too distant future, our 400 or so JSP pages will be replaced by one or two main HTML templates and about a dozen small (less than 100 lines each) HTML component files.  But for now, take a look at our printable CRF design as an example of the way forward.

Getting to the Point: REST, JSON, JQuery, HTML, and CSS

What follows is a description of the processing path that starts with a REST URL and ends with a printable CRF.

  1. A user will click on a print icon that is part of many of the CRF view forms. The RESTful URL referenced in the link will be in the form of rest/metadata/html/print/{StudyOID}/{StudyEventOID}/{FormDefOID}. Using this combination, a wildcard asterisk character (*) can be placed as a specifier for all studies, all study events, and all CRFs, respectively.
  2. The first path element in the URL named “rest,” indicates that this is handled by our implementation of org.akaza.openclinica.web.restful.ODMMetadataRestResource, our Jersey JAX-WS controller servlet. The “metadata” in the second path element indicates that is for metadata only and no clinical data will be transmitted. The “html” in the third path element indicates that this will result in a rather simple JSP page at /WEB-INF/jsp/printcrf.jsp. This JSP page is the container for the JQuery code that will make a second REST call to the back-end to retrieve the CDISC ODM in JSON form and is also the container for the Javascript and JQuery code that converts the information contained in the ODM JSON into an HTML DIV element with the rendered printable CRF.
  3. The AJAX call that the Javascript method getPrintableContent() in js/app.js references is a URL in the form of rest/metadata/json/view/{StudyOID}/{StudyEventOID}/{FormDefOID}. It is the 3rd path element of “json” which indicates that the same ODMMetadataRestResource servlet will now fetch the relevant ODM XML metadata, convert it to JSON, and send it back to the callback portion of getPrintableContent(). In the callback portion, a call to app_odmRenderer.renderPrintableStudy() kicks off the process by which JavaScript inspects the JSON ODM object returned by the server and builds a DOM element that represents the portion of the metadata that is meant to be displayed as one or more CRFs.
  4. The DOM HTML is rendered with the help of JQuery Templates. This allows HTML fragments such as template/print_item_def.html, which are initially loaded in memory, to be combined with certain extracted key/value pairs to render an individual or list of components.

What’s on the Horizon

This first release extends to printing blank CRFs. Then, we will work to extend this to handle printing CRFs containing clinical data and very large printable form sets. The process described above will be similar, with the exception that all large documents, typically over 100 pages long, will be rendered using a Java rendering class that builds off of Velocity templates. The resulting server-side HTML page will be converted to a downloadable PDF.

– Nick Sophinos, Senior Developer

Click here for Developer Release

OpenClinica to present at DIA China Annual Meeting

There are numerous opportunities to learn about OpenClinica at the upcoming 5th DIA China Annual Meeting <http://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=31144> . The conference, held at the Beijing International Convention Center, runs from May 12-15. The event is expected to attract over 1,200 participants and is the largest annual meeting held by DIA in the Asia and Pacific region.

OpenClinica representatives will be hosting an exhibit as well delivering three poster presentations and one lecture:

  • CDISC Standards to Enhance Clinical Trial Efficiency
  • The Importance of Validated EDC System to Ensure Quality of Data
  • Electronic Data Capture (EDC): Providing A Significant Cost-Efficient Platform In Current Clinical Research Management
  • The Adoption of Electronic Data Capture (EDC) for Clinical Trial Data Management in China – The Case of ATHENA Healthcare Consultancy

Be sure to stop by the OpenClinica booth A18 to learn about new developments with the leading open source clinical trial software.

Coming up soon, OpenClinica will be running a public, open enrollment training class in Shanghai (June 4-7). More information <https://www.openclinica.com/open-enrollment-training> .

Importing OpenClinica Data Into R

R is a powerful open source statistical software package–many people think of it as an open source alternative to SAS. A number of OpenClinica users have been asking about how to bring data from OpenClinica into R. So, we recently published a write-up in the OpenClinica reference guide, providing instructions for importing data into R in three different ways:

  •     using a Tab-delimited file,
  •     using a CSV file, and
  •     using an Excel file.

Feedback and additional ideas are welcome.

– Ben Baumann

Using Patient-centered Technology to Improve Recruitment and Retention

Sponsors of clinical research must increasingly focus on improving patient engagement in order to meet many of today’s research challenges. Promising disruptions are already under way that could define new models for patient recruitment and retention.

In a time when drug development success is becoming scarcer and more expensive, the industry is looking everywhere it can for new, innovative approaches to improving health. Meeting recruitment goals is one of the biggest challenges for traditional clinical research. Less than one-third of people who come in for a screening end up completing a clinical trial.1 Thinking in a more patient-centric manner can help is in recruiting patients. A fundamental idea behind patient-centered research is to “amplify the patient’s role in the research process.”2 Employing new ways to engage patients and physicians while increasing their level of knowledge and trust can improve the sponsor’s ability to meet recruitment goals.

One often overlooked factor for study participation and retention is convenience. Raising the level of convenience for both the investigator and participant can eliminate a huge obstacle to non-participation or non-completion. There are many ways to incorporate increased levels of patient and physician convenience into trial design and execution, particularly using Internet-based technologies. For instance, social media can be an effective recruiting tool and an important way to build trust with targeted populations. Disease-specific online communities are becoming more and more prominent for chronic diseases. Matchmaking tools act as mediators that draw together researchers and participants. “Traditional” social media offers a less targeted, but no less effective, way to engage patients and investigators.

In general, the four key determinants of a person’s likelihood to participate in a trial are prior participation in research, existing relationships with researchers, involvement of trusted leaders, and trust in the organization. Keys to recruiting success in social media should keep these determinants in mind, and engage communities in a thoughtful, ethical way while respecting the norms of the community you are targeting.

Participant retention post-recruitment can be improved by strengthening the connections between participants and researchers, and enhancing communication structures to support these relationships.3 Capturing Patient Reported Outcomes electronically (ePRO), through the web or mobile devices, offers a way to interact with the participant in a meaningful way while also capturing critical data. For instance, offering the ePRO user risk scores and health recommendations based on their data, or using gamification techniques to increase protocol adherence, can enhance the traditional ePRO experience by offering direct, immediate value to the user. Enabling a “Bring Your Own Device” (BYOD) strategy can increase convenience for populations who already own their own smartphones or tablets. Of course, the study design and applicable regulatory considerations should drive when and how these techniques are used.

Increased focus on the patient experience is not a phenomenon unique to research, but something that is rapidly permeating healthcare systems. These rapid changes can enhance research engagement. There is enormous potential to capture far more robust data and have better follow up than ever before as widespread infrastructure is put in place for coordinated team-based care, home-based continuous monitoring, and wireless data reporting from medical devices. The (still elusive) promise of using the Electronic Health Record system in research to identify participants and capture clean, accurate trial data is more critical than ever before. As medical practices become more electronic and less paper-driven, investigators and staff should be engaged by providing them trial-specific information at the points in their workflow when they can best make use of it. Conversely, requiring them to go outside the workflows and systems they use in routine practice creates complexity and hassle that can deter research participation. A new level of integration between research and health data systems, based on standards (which exist) and open interfaces (which are coming, as part of Meaningful Use), will be necessary to make good on this potential.

As difficult research questions drive increased complexity in trial designs, many feel that the answer is to use technology in simple, scalable ways to engage more participants in research and capture more data. Dr. Russ Altman, a physician and Stanford professor recently told the New York Times, “There’s a growing sense in the field of informatics that we’ll take lots of data in exchange for perfectly controlled data. You can deal with the noise if the signal is strong enough.”4

References

1. Getz, Ken, The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial, 2007, p40.

2. Pignone, Michael, MD, MPH, Challenges to Implementing Patient-Centered Research, Ann Intern Med. 18 September 2012;157(6):450-451

3. Nicholas Anderson, Caleb Bragg, Andrea Hartzler, Kelly Edwards, Participant-centric initiatives: Tools to facilitate engagement in research, Applied & Translational Genomics, Volume 1, 1 December 2012, Pages 25-29, ISSN 2212-0661, 10.1016/j.atg.2012.07.001.

4. http://www.nytimes.com/2013/01/15/health/mining-electronic-records-for-revealing-health-data.html?ref=health?src=dayp&_r=3&

OC13: Early Bird Registration Ends Friday, March 22!

Friday, March 22 is your last chance to get early bird registration for OC13! Take advantage of this final opportunity to obtain discounted pricing on conference admission, workshops and training.

We have a superb line-up of useful content this year, including a new series of in-depth workshops taught by subject matter experts:

  • Moving from paper to EDC
  • Advanced Edit Checks and Rules
  • Operating OpenClinica in a Regulatory Compliant Environment
  • OpenClinica Web Services & Enabling Modularity
  • Orientation of OpenClinica Code Base
  • Installing and Administering OpenClinica

OC13 also coincides with this year’s DIA annual meeting, so now you have TWO great reasons to come to Boston this June.

Does EDC Help or Hurt Site Relations?

Getting reluctant clinical research sites to embrace technology such as electronic data capture (EDC) software can be difficult. This is a recipe for troubled relationships between the sponsor/CRO and sites. However, just as it is possible for a poor EDC implementation to erode sponsor-site relations, it is also possible for the EDC software to help cultivate improved relationships. Take a look at the new whitepaper, “Improving Site Relationships through EDC” to learn about some important considerations when thinking about site relations in the context of EDC.

OC13 – OpenClinica 2013 Global Conference draws clinical research community to Boston

OC13 is an educational event open to anyone looking to obtain insight into the OpenClinica clinical trial software platform, learn useful new skills, and build relationships within the vibrant OpenClinica community. This year’s event features best practices, case studies, demos, and hands-on activities. View the conference program to choose from a list of valuable sessions such as: “Utilizing CDISC Standards to Drive Efficiencies in Study Set-up and Build,” and “The Changing Face of Clinical Trials – Patient-Centered Research,” to a sneak peak at exciting future developments for OpenClinica.

Attendees can also choose to participate in a set of hands-on workshops and training classes. These workshops deliver highly-relevant information on key subjects such as regulatory compliance and validation, web services and integration, edit checks and rules, and moving from paper to electronic data capture (EDC). For a more thorough understanding of OpenClinica, you can take full “Central User” or “Developer” training on this robust platform.

Early bird registration is available until March 22.

Kicking-off the conference as keynote speaker is Douglas Bain, a recognized veteran in the eclinical industry who has worked in a leadership role with many prominent clinical research technology leaders. In his address, Mr. Bain will focus on the emerging dynamics of patient-centered clinical trials.

“I am thrilled to deliver the keynote at this year’s OpenClinica conference,” said Mr. Bain. “Clinical research modalities are changing, and I look forward to sharing my insights into where things are headed with such an innovative community.”

Conference attendees are invited aboard the Odyssey for a dinner cruise and unique views of the city from Boston Harbor.

Also in Boston, immediately following OC13, is the 49th DIA Annual Meeting, June 23-27 at the Boston Convention and Exhibition Center.

About OpenClinica

OpenClinica is the leading open source clinical trials software platform, and increases the quality and pace of clinical research worldwide. With a global community of users and thousands of implementations, OpenClinica presents a compelling way to obtain greater value in clinical trials. The OpenClinica software is backed by Waltham, Massachusetts-based OpenClinica, LLC, who provides commercial grade support for the open source platform. For more information – including product downloads – visit http://www.openclinica.com or follow @OpenClinica on Twitter.

OC13: OpenClinica 2013 Global Conference

We’re gearing up for a fantastic conference, June 21 in Boston. You don’t want to miss the informative workshops, sessions, and demos that will help you optimize your research based on the cutting-edge OpenClinica open source platform. And, Doug Bain from eClinicalHealth is planning an engaging keynote presentation that covers the critical movement toward patient-centric trials. Oh, and I should mention the amazing dinner cruise on Boston Harbor.

Haven’t registered yet? Get a jump on it (and a discounted fee).
Early-bird Registration >>

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