Connecting at the Connectathon

CDISC has broad support for its fledgling standard whose evolution is critical to the acceleration of technology adoption in clinical trials.

If you missed the CDISC Clinical Data Connectathon at the DIA annual meeting in Denver, you may have missed the event of the seasonand an almost impenetrable crowd. The evening event on 10 July surprised everyone by attracting an estimated 1,000 people. It included active participation by a number of biopharmaceutical organizations.Most of the key clinical trial technology companies attended.

What is a Connectathon you ask? Well, that takes some explaining.

CDISC and the ODM
The Clinical Data Interchange Standards Consortium (CDISC) organized the event, which was jointly sponsored by 23 of its corporate sponsors and members. CDISC is a nonprofit organization founded with the vision of creating data interchange standards for the pharmaceutical industry to streamline the clinical trials process. CDISC hosted the Connectathon as a proof-of-concept demonstration of its ODM XML standard.

The ODM (Operational Data Modeling) group is charged with creating a standard format for representing study metadata, study data, and administrative data associated with a clinical trial. The model uses XML (eXtensible Markup Language) to create a system-neutral exchange format for transferring data between systems and for archiving data. In essence, the ODM XML standard enables the sharing of clinical data and its associated metadata between entirely different information systems.

Transferring data between different systems and archiving data are two of the thorniest issues complicating electronic clinical trials. Creating a standard that achieves consensus among all the major clinical trial software vendors, CROs, central labs, and sponsor companies is a monumental taska task that no one has attempted previously. But without standards in place, clinical data integration typically requires a significant software development effort. The acceptance of industry standards yields data integration efficiencies and process innovations, and speeds technological advancements.

The Connectathon
CDISC organized the Connectathon as a demonstration to show the utility of the ODM XML standard for the exchange of structured information by clinical data producers, reviewers, and analysts. Participants were issued version 1.0 of the ODM standard, an XML dataset, and two tests they could perform to show compliance with the standard. (CDISC also provided food and drinks.)

The Connectathon brought together many vendors that demonstrated the ability to work with a common ODM XML dataset. Systems connect virtually by demonstrating the ability to read and write the same dataset. Thus, if a system can generate an ODM XML dataset, and can load that same dataset, any two systems supporting the standard can theoretically share data. Of course, the gap between the theory and reality is significant, but that shouldnt undermine the value of the Connectathon exercise.

Twenty participating companies collaborated (see box) to demonstrate compliance with the standard. Twelve of those companies submitted test evaluations to the CDISC Testing and Applications Team, which had prepared a test kit. Companies could either demonstrate that they are able to export data in a file compliant with the ODM XML standard or that they can import data into their own system from an ODM XMLcompliant document. Optionally, participants could combine the two tests by loading an ODM XML dataset into their system, modifying the data, and writing the updated data back out into a new ODM XML dataset. Of the 12 companies that submitted test evaluations, 9 completed the combined test.

The goal of the Connectathon was less about showing off a functioning standard than about displaying broad support and commitment to the standard. Real commitment means that participants actually build support for the standard into their products. The Connectathon provided a straightforward test for vendors and other companies, including biopharmaceutical companies and CROs, to show compliance with the evolving standard.Impressively, the Connectathon included a significant number of the clinical trial system vendors standing together in support of a common standard. When was the last time you saw 15 clinical trial system vendors agree to anything? Several participants went over and above the test requirements, displaying additional capabilities or showing live demonstrations of systems interacting via the standard.

Practical application
Most important is practical application of the CDISC ODM standard. For the Connectathon, CDISC used data transfer between a CRO and a sponsor as the use case, or real-world example, underpinning the technical test. Other use cases include transferring data from an EDC (Electronic Data Capture) system into a CDMS (Clinical Data Management System), loading subject diary data into an EDC system, loading laboratory data into a CDMS, and archiving audit trail information.

In the Connectathon use case, a sponsor company has hired a CRO to collect, clean, and compile the data for a randomized clinical trial. In this scenario, data transfers are typically conducted at study milestones such as when some predetermined quantity of study data is entered, or when the database is locked. The sponsor company uses a commercial data management system and the CRO uses a proprietary data management system. These two systems are completely different, using distinct platforms, databases, and processing conventions. The two companies have agreed, however, to a common set of variable names and code lists and will use the CDISC XML ODM as an intermediary for data interchange.

The two companies agree on a traditional approach to implementing the ODM, such that a Form in the model represents a page in the CRF (Case Report Form), and a StudyEvent in the model represents a visit. The CRF was designed to group related data on a form organized by domainssuch as demographics or concomitant medications.

Thus, the XML ODM standard enables the sponsor company and CRO to exchange information regardless of the fact that they maintain the data in entirely different CDM systems. Outsourcing and partnerships become simpler when clinical data can be exchanged using a standard format. By agreeing on a data standard, the two organizations can deploy the technologies that best fit their businesses, yet still share the information without the need for expensive and error-prone data integration work.

The vision
The CDISC ODM XML standard enables software innovation. Beyond data interchange, data standards accelerate the acceptance of new technologies. Currently, commercial products are built using conflicting data standards, impeding the ability of organizations to combine best-of-breed technologies toward an optimal solution. For example, EDC adoption has been hampered by the inability to seamlessly integrate with legacy CDM systems. With the acceptance of a data interchange standard, the systems will be able to eliminate data interchange as a significant barrier to entry.

Just as data interchange standards accelerate the acceptance of new technologies, they will significantly reduce the cost to switch from one technology to another. Ideally, companies will build data management processes around the data standard, and as long as they license and develop products to that standard, they are not locked in to any one solution. That should have the positive effect of driving vendors to continually improve their products.

The application service provider (ASP) model for providing software as a service would also benefit from data interchange standards. ASP vendors would use the ODM standard in much the same way that the CRO exchanged data with the sponsor company in the Connectathon use case. For example, a pharmaceutical company could outsource data collection services to an EDC provider via the ASP model, and data exchange could take place via the ODM XML standard. This would have the added advantage of allowing the pharmaceutical company to use different EDC service providers for different trialsor even to change vendors mid-study.

The CDISC ODM group has been hard at work improving the usefulness of the ODM XML data interchange standard. Understanding the limitations of version 1.0, the group has aimed to add significant new features to a 1.1 version scheduled to be released for comment at the end of the summer. The 1.1 version will contain new capabilities such as lab data, an improved audit trail, and a more dynamic study-event model.

The challenge
The Connectathon was largely a success, but serious challenges remain for the ODM standard. Primarily, these involve creating a standard complete enough for broad-scale use. Although version 1.0 of the ODM standard has significant limitations, those limitations say less about the future of the standard than about achieving an early milestone with known shortcomings. The Connectathon tests were executed with this early version of the standard and have sparked healthy feedback from participants and observers alike. Future versions will address much of what was learned from the Connectathon experience.

Achieving broad support for the standard is another challenge. If the Connectathon is any indication, support from most of the major software vendors, CROs, and pharmaceutical companies can reasonably be expected.

And, as it turned out, getting food at the Connectathon was more challenging than one might imagine. With many more attendees than expected, the food allotment was consumed in short order. Fortunately, drinks were in plentiful supplydiffusing any potential rioting that might have been fueled by ill-fed data managers.

Parting thoughts
If you missed the Connectathon, you may have another opportunity. There have been many requests and offers to sponsor another CDISC Clinical Data Connectathon in Europe in conjunction with the Drug Information Association (DIA) Clinical Data Management meeting in Paris at the end of October. Because of the relatively tight timeline, that Connectathon will likely also use version 1.0 of the ODM specification. And given the fact that the last Connectathon drew triple the expected number of attendees, CDISC will surely schedule a larger room. Keep an eye on the CDISC Web site (cdisc.org) for more information.

Overall, the first-ever CDISC Clinical Data Connectathon was an immense success that provided the ODM group with significant momentum. More than a technical tour de force, the Connectathon showed broad support for the fledgling standard whose evolution is critical to the acceleration of technology adoption in clinical trials. Continued industry support is essential to the ODMs ultimate success, especially given its daunting mission to create a universal clinical data interchange standard.