Optimizing Clinical Architecture
December 13, 2006
The high prominence of electronic data capture has obscured the importance of the clinical data management system (CDMS) and the clinical trial management system (CTMS). Neither is especially exciting or electrifying.
That’s not our judgment. It’s obvious from the lack of investment or entrepreneurial activity in either the CTMS or CDMS niche that neither makes the financial community’s heart (such as it is) beat faster. To create a CDMS or a CTMS properly, you need hard-won experience. You cannot create either type of application fresh out of graduate school. There are very small numbers of CDMS’s and CTMS’s. And they are at least a generation older than today’s leading electronic data capture (EDC) tools.
The Perplexing Diagram
We were intrigued to see a variety of other industry publications skirting the periphery of this issue. ClinPage is not early to the debate.
One story has proven especially perplexing. In it, an EDC company that does not offer a CDMS had a lovely diagram showing ... something unexpected. The diagram shows the order that a CDMS could restore to the clinical data landscape. Why would a company tout a product that it doesn’t sell? We are still scratching our head on that.
Next to that diagram is another that is considerably less tidy. With any number of lines, double-pointed arrows and compartments, it shows a rat’s nest of connections and one- and two-way linkages between every clinical technology subsystem under the sun. This is probably close to reality at many companies sponsoring clinical trials.
Those CDMS and CTMS are not, conventionally, considered in the same breath. Many readers are no doubt already irritated that we’re talking about them at the same time. We understand the differences. We understand that comparing CDMS and CTMS is like comparing apples and pine cones. We’re simply tossing them in the same bucket for a moment.
The trouble is that the existing CDMS and the existing CTMS’s are of a significantly different vintage than the leading EDC solutions. The existing CDMS’s and CTMS’s were not imagined with the internet in mind. They were not imagined with XML or .Net or CDISC in mind. They were built a long time ago. Which isn’t bad. It’s not inherently a problem. It’s just not clear to us how the CDMS and CTMS of tomorrow will be freshened and synchronized with today’s EDC tools.
So the industry faces a dilemma. Crucial software used by every company in the industry is out of date. The heavy iron CDMS and CTMS in use today were designed to manage paper, not electronic data. They were conceived in the absence of an increasingly central element of the clinical trial today: EDC. It’s not clear whether any commercial firm has either the interest or the resources to bring the CDMS and CTMS into a broadband era, much less whatever the next era is going to be called.
Should some enterprising company in Mumbai or San Diego develop a new CDMS/CTMS from scratch? Should the whole idea of CDMS/CTMS be retired? Evolve?
If not a CDMS to hold the data, or a CTMS to manage a trial, is some new hub, warehouse or application destined to be created from scratch at every company in the industry? And if there are 100 different custom-built CDMS and CTMS systems in a decade, will the whole industry grind to a stop for lack of the ability to share data?
Companies that have not invested in expensive CDMS and CTMS may have more flexibility. For some sponsors, indeed, the capabilities needed in CDMS and CTMS are shrinking rapidly. That’s because EDC tools can do more and more. In some cases, EDC systems can manage much of what a CDMS can do. A few CTMS systems are or soon will be integrated with EDC, but it’s rare. Generally, EDC systems cannot look at trends across trials, manage portfolios of trials, or trigger payments to investigative sites. That territory is safely held by the specialized CTMS suppliers.
What’s at stake? Plenty. The ability to make decisions. Lock complex trials. Manage multiple streams of information. Resolve data clarification forms. Generally move forward. It all depends on assimilating information, both from within individual trials and across multiple trials. Something needs to be at the heart of the clinical technology diagram. The question is what.
(Note: A version of this article was originally distributed in the free, weekly ClinPage email sent to those who register on the website.)