Notes from the 23rd DIA CDM conference
While I’m not enamored of attending conference sessions that start at 8:30 in the morning, I was glad that I made it to the Tuesday morning session on “Accessing Clinical Trial Management Information from eClinical Systems and Capabilities” chaired by Paul Bleicher of Phase Forward.
Before I jump into the details, I want to warn you that the words “clinical trial management information” in the title of the session can be misleading. This is because of a key learning that I took away from this session. In short, when we begin to effectively extract and use data and metadata from all of the transactional systems at our disposal, they become (in aggregate) a comprehensive clinical trial management environment. In other words, we no longer need a CTMS because we have achieved a CTME(nvironment).
A good illustration of this was given by Mark Sonenblick of PharmaNet who showed how the creation of a centralized metadata repository fed by all of the key systems (i.e. EDC, CTMS, IVRS, CDMS) allows you to retrieve, combine, analyze and report on operational data for multiple purposes. By letting the data and metadata out of their individual silos, you gain the ability to have visibility into the entire clinical trial process. The more systems included, the better the view. As is normally the case, creating the links to each of the systems, standardizing the metadata for reuse, building the portal and/or dashboard for accessing the data and/or creating the standard reports from them is no easy task. A small but important consolation for those willing to take the plunge is that emerging data standards and newer software development methods/tools (e.g. SOA) make this work a lot easier than in the past.
A real world illustration of systems integration and metadata reuse was then given by Lora Todd of Eli Lilly. In particular, this talk focused on the extraction of operational (as opposed to scientific) data from source systems (i.e. – EDC, Laboratory, IVRS, CTMS, Genomics and Resource Modeling) and their use to generate management reports. In Lilly’s terms, this capability gives improved access to clinical performance information. For example, the metadata can be used to generate information on trial progress at each site and provide for faster and better decision-making for both sponsor and investigator site staff. The metadata can also be used to improve the quality of the data being collected through exception and problem reporting. The system was build in-house by Lilly and includes a data warehouse, purpose built data marts and a user interface that allows casual, primary and expert users to retrieve and view the data in multiple ways. When necessary, the data can also be handed off to third party applications such as Business Objects to generate additional insights.
The third talk, by Leslie Bihari of eClipse Professional Services, was perhaps the most comprehensive in illustrating how metadata could be extracted and reused from all of the systems supporting clinical research. The following two "before and after" schematics extracted from Mr. Bihari's talk (click here to see the whole presentation) clearly show that the information available in an integrated environment (second slide) is far richer and therefore more valuable than data collected in a stand-alone CTM system (first slide).
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(Click on the image to open a larger version in a new window)
It is his contention that the integrated environment can enable the following goals:
- Ability to survey the entire clinical landscape
- Ability to cross application boundaries
- Ability to enter data once that can then be shared by all
- Ability of each user to dircectly access reports relevant to their work
- Enable IT to partner more closely with business
- Enable company staff (including IT) to partner more easily with vendors
The simple truth that arose when thinking about these three talks in aggregate is that regardless of the technology used, it is imperative that the metadata now trapped in isolated clinical systems be freed and used to guide informed decision making.
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