With Good Clinical Trial Technology, Why Is Data Still Double Entered?

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With Good Clinical Trial Technology, Why Is Data Still Double Entered?

Jeremiah Rehm, Product Manager
That's just the first in a long series of persistent questions in the clinical trial industry. Why don't we have one consolidated place to see all information regarding a specific region, site, or patient? How come every clinical trial seems to use different terminology and disparate applications (resulting in a new learning curve and low user adoption)? Why can't we get ad-hoc reports in a format that is actually useful, covering a timeframe we actually care about? When will the promise of ‘seamless integration' realistically be fulfilled, not just internally, but also across the Sponsor-CRO(s) gap? Why must I track multiple login and password credentials? What about international clinical studies? Can't industry standards help?!? 

Traditionally, management has perceived the labor of clinical trial professionals as more affordable than integrating the various clinical trial systems being used. But this perception is rapidly changing; and for many of us, it already has. I'm interested in hearing about how the ‘integration of clinical systems' dynamic has played itself out (or is currently unfolding) within your organization. In my experience, here's what I've seen:

• This is MY Sandbox!: Vendors will always tell you they play ‘nice' with others (some might even mean it), but very few actually do it. And even fewer prove it by supporting such fundamental functionality as reusable web services, multiple format options for export files, and aligning their product data definitions with existing industry standards.
• The Bottom Line: It's fairly straightforward discussing EDC, CTMS, and other clinical trial systems with the ClinOps group; after all, the features these products provide make their lives easier (or should). Usually the IT and Regulatory groups are on-board as well. The difficulty is in justifying the corresponding financial and personnel investments to the management team by clearly proving that user adoption will be high, thus resulting in a quick and definitive return on investment.
• It's a Pharma Gold Rush: Many, many clinical vendors have made huge fortunes off Sponsors and CROs alike by linking their systems together using outdated, point-to-point integration technology. And even worse, once these clients are locked in, they're forced to go back to the vendor for long, costly reprogramming/revalidation cycles every time one of the connected systems releases an upgrade!

So I'm sending this call out to Study Managers, Site Monitors, CRAs, Clinical Project Managers, Investigators, Clinical Site Coordinators, Trial Research Assistants, Technologists, Programmers, Regulators, and all others involved in the conduct and management of clinical trials. Tell me your experiences, frustrations, successes, and current issues regarding this important and timely topic.

Please post a reply, someone is listening.

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