By Deborah Borfitz
August 18, 2008 | Enrollment success might be a more common occurrence if study sponsors had a better means to tap their existing know-how about patient recruitment across clinical trials. A Web-based “Center of Excellence” product recently offered by e-recruitment company TCN e-Systems will do just that, says Jaime Cohen, data management lead.
“An amazing wealth of patient recruitment data exists within sponsor organizations, but it seldom resides in one place that everyone can easily access,” says Cohen. “The data and expertise necessary for patient recruitment is too mission-critical to reside in silos. All too often, only a handful of individuals possess the strategic knowledge or perspective to leverage this data to inform the enrollment process.”
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| Jaime Cohen |
The new tool is designed to “institutionalize” patient recruitment expertise in the same way that the company’s flagship TrialCENTRALNet product has been used on a protocol to protocol basis by BBK Worldwide, a patient recruitment company under common ownership with TCN e-Systems, for the past seven years. It was developed in response to a movement among industry sponsors to bring responsibility for enrollment success in-house, says Cohen. “Three to five years ago…a study would be extended [to accommodate recruitment delays]. There was nonchalance about it.”
TCN e-Systems’ Center of Excellence is a framework to build institutional knowledge, including “lessons learned” from previous studies that can be applied to current and future trials, says Cohen. Many sponsors try to accomplish this via a paper-based library of materials produced and approved by regulatory authorities for a specific trial. The new tool makes the hunt for relevant information less cumbersome by putting everything online and searchable in Google-like fashion.
In addition to BBK Worldwide, two large industry sponsors are already using the Center of Excellence product. Both of these companies are in the initial three-to-six-month process of building their electronic library, says Cohen, and suffering none of the usual “analysis paralysis” regarding what documents should be imported or how it should be categorized and accessed. Those answers are built into the product.
A companion online training product, QuickTrainer, is also available to help companies build their own patient recruitment infrastructure in-house, says Cohen. The eight-module, Web-based program includes reading assignments and practical exercises to help users understand recruitment essentials and how to apply them to current clinical projects. Exercises are reviewed by a patient recruitment advisor from BBK, which recently released a book (Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success) upon which course content is partially drawn.
Center of Excellence has the same look and feel as TrialCENTRALNet, says Cohen, so the user interface is easy to navigate and screens are uncluttered. “It provides [users] with the information [they need] in just a few clicks.
Perhaps the most important feature of the new tool is integration of a “site readiness index,” says Cohen, which organizes and follows the process from site identification until the first patient is screened and “the clock starts ticking on patient recruitment.” Sponsors rarely meet site readiness goals and, up to now, have had a tough time even identifying bottlenecks telling them where to target their resources. The Center of Excellence product would be superfluous if it failed to address that issue, she notes.
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