While tablet software maker Mi-Co is showcasing an integration of their Mi-Forms tablet-based forms software with OpenClinica that can be used in “offline” settings, elsewhere within the OpenClinica community, Raymond Omollo and Michael Ochieng have developed a separate option for using OpenClinica in settings without internet connectivity. Their method synchronizes multiple locally deployed instances of OpenClinica with a central OpenClinica database. Michael and Raymond recently presented their work at the OC13 conference. You can access their presentation slides here to see how they address key issues such as synchronization, back-ups, encryption, and user training.
While working for Drugs for Neglected Diseases initiative (DNDi), Michael and Raymond devised this approach for a WHO study of Buruli ulcers in West Africa (Ghana and Benin). The study, which is ongoing as of the date of this post, is a randomized controlled trial comparing the efficacy of 8 weeks treatment with clarithromycin and rifampicin versus streptomycin and rifampicin. It involves 430 subjects across 5 sites. The participating sites have limited or unstable internet connectivity, so a solution is needed that provided timely, auditable, and quality data entry given this constraint. A positive byproduct is enhancing the capacity of these disconnected sites to utilize EDC.
As they say, necessity is the mother of invention. And open source makes it easier for people to believe that what is necessary can in fact be accomplished. Kudos to Raymond and Michael for devising a solution that works for them. Perhaps it may work for others as well. If you’d like to access the source code and documentation for their work, you can download these from the OpenClinica Tools and Tips page (scroll to bottom). You can reach Raymond and Michael on the OpenClinica Developers mailing list: firstname.lastname@example.org.
– Ben Bauman
More About DNDi
Headquarted in Geneva, DNDi is a global organization that develops safe, effective, and affordable treatments for neglected diseases. The neglected diseases that DNDi tackles afflict many of the world’s poorest people (Malaria, Leishmaniasis, Chagas disease, Sleeping Sickness, Paediatric HIV, Filaria). DNDi’s goal to develop 11 to 13 new treatments by 2018. More at www.dndi.org.
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:
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.
We’ve been working hard on the OpenClinica 3.1.3 release and recently published a beta release. While 3.1.3 is technically a maintenance release, it is quite substantial, covering 176 fixes and enhancements. The following is a summary of what’s included. For a more complete and detailed list, please view the Project Roadmap page in the Issue Tracker (login required).
Improved performance for CRF data entry/editing, the View Study Subject page, and the Notes and Discrepancies page
Fixes and improvements to SPSS output format
Improved server stability
An overhaul of OpenClinica’s internationalization/localization support to fix defects and increase ease of use.
Fixes to problems with data entry/editing in repeating groups
Support CRF Version migration for individual event CRFs
Rules can be run at data import and when loading data via web services
Fixes to nested simple conditional displays in CRFs
Option to require strong passwords
Fixes to missing database constraints for OpenClinica installations upgraded from 2.5 or earlier
OpenClinica’s web services layer provides a powerful mechanism for programmatic data interchange between OpenClinica and other systems. Below are the first two videos in a series of tutorials on working with web services. The videos are created by Hiro Honshuku, including the background music! Thanks Hiro!
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 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.”