Nov. 15, 2006
| There’s no escaping the imposing numbers of choices in launching a clinical trial using electronic data capture (EDC). Some of these turn on the software being used. Others touch process or a particular therapeutic area.
Indeed, there are people in the industry who fret that all of the time that EDC is believed to save at the end of a trial is actually spent at the start. That’s when what seems like a simple paper protocol is rendered into computer code. Consultants can do that rendering, as can contract research organizations, as can technology suppliers. It hardly matters. It eats time no matter who does it.
Is there a better way? Fast Track Systems says it has one. The company estimates that errors related to clinical trial protocols alone cost the industry $710 million annually. The company has a robust clinical trial consulting practice upon which a software application, TrialSpace Designer (TSD), was based. There are modules for contract research organizations and grants management.
Fast Track’s CEO, Ed Seguine, came to Fast Track from Lilly, where he guided the drug maker’s venture capital arm. Seguine notes that the TSD software has moved from just being an adaptation of clinical trial protocols written in Microsoft Word. “We’ve extended the model of being able to author protocols to be able to capture information that is used in other workflow streams,” Seguine says, citing not only EDC but also statistical plans and operational setup activities.
In much the way that personal tax-planning software can ask a series of questions and generate a battle plan, TrialSpace Designer helps users avoid common mistakes and adhere to industry- or company-specific guidelines that have been validated by Fast Track’s database.
The idea is to know whether a particular component of a trial is within the norm or an outlier. Often, Seguine says, teams add elements to trials without being able to assess their impact. “These productivity investments that you’re making are generally predicated on efficiency. That’s all dependent on doing the same activities and knowing where to focus. If you just do EDC in isolation, it will help you do things,” he says. “But it doesn’t help you do the right things.”
As an example, he proposes that a particular protocol called for five electrocardiograms for each patient. Is that high? Low? The Fast Track application and database can help. As such, it can be a yardstick that measures not whether your trial is the right approach, but whether it’s within industry benchmarks.
That basic rationale behind any element of a trial, Seguine says, can be obscured in all the debate and effort to deploy EDC and other clinical technologies. “Actual adoption rates languished for years and years,” Seguine says of EDC. “Now they are starting to pick up. Some companies are making big moves. Our tool is a caboose to that. It makes no sense to say you can use metadata if you don’t have a platform to make use of that metadata. You have this giant chasm between translating information imprisoned in a paper document to all of these new technology platforms.”
Lilly is a happy customer. Stephen Ruberg, director of medical information sciences at the Indiana company, is on record as saying: “At Lilly, the concept of leveraging promising new technologies and business models is embedded into the way we conduct business on a daily basis. We have had an excellent partnership with Fast Track in moving from beta testing of TrialSpace Designer to our current work on authoring protocols. We see great potential for TrialSpace Designer to address process challenges and costly inefficiencies in many downstream activities such as setting up data management systems and populating our clinical trial registry.”
Lately, Fast Track has used TSD to define a clinical trial protocol, statistical plan and operational details — and export all that according to the CDISC operational data model (ODM) standard. From there, Fast Track reports, the exported data can be used to set up an EDC-based trial.
Fast Track has successfully tested that approach with several major technology companies. The company has validated that the optimized study from its TSD plan was faithfully represented in the EDC system. One last point: Fast Track believes such a strategy anticipates likely future CDISC-oriented policy changes at the FDA and delivers on much of the original promise of EDC.
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