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"As pressure builds for clinical trial sponsors to assume fullaccountability for patient recruitment outcomes, acquiring all of theknowledge necessary for successful study enrollment poses a variety ofoperational challenges," said Jaime Cohen, TCN e-Systems data management lead."For a clinical trial to succeed, all stake holders must understand what ittakes to drive timely patient recruitment, and have easy access to theinformation necessary to make it happen."
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TCN e-Systems' Center of Excellence is designed to institutionalizepatient recruitment expertise by establishing an easy-to-use infrastructurefor creating, collecting, standardizing, and disseminating institutionalknowledge throughout a given life-sciences company. The technology leverages25 years of experience of the global patient recruitment leader, BBKWorldwide, with whom TCN e-Systems has teamed to develop the product.
"An amazing wealth of patient recruitment data exists within sponsororganizations, but it seldom resides in any one place that everyone can easilyaccess," Cohen said. "The data and expertise necessary for patient recruitmentis too mission-critical to reside in silos. All too often, only a handful ofindividuals possess the strategic knowledge or perspective to leverage thisdata to inform the enrollment process."
Studies have shown that the enrollment period for clinical trials remainsone of the most prolonged periods in the development cycle for new drugs, andpresents a large opportunity for sponsors to reduce time to market for newmedicines and medical devices.
"However, creating a centralized repository of patient recruitment data isonly the first step," Cohen said. "All members of the study community need toknow how to use it to optimize patient recruitment, and this requireswell-planned, consistent training. When people understand the theory andpractice behind recruitment, they can become strategists who can more deftlyidentify and apply the specific methods of intervention that will enhancerecruitment."
To accomplish this additional goal, TCN e-Systems developed a companiontraining product, called QuickTrainer(SM). Made up of online training modules,QuickTrainer guides "students" through a stepped approach to learningrecruitment essentials and applying new knowledge to current clinicalprojects. Each module has reading assignments, practical exercises, andfeedback from expert patient recruitment advisors to reinforce learning.
QuickTrainer course content is partly drawn from BBK Worldwide's recentlyreleased book, Reinventing Patient Recruitment: Revolutionary Ideas forClinical Trial Success, and a BBK patient recruitment advisor is assigned toeach QuickTrainer participant to provide personalized feedback. The program'ssecure, permission-controlled environment allows access across geographicregions and time zones, offering convenience to study team professionals withbusy travel schedules.
"Global study teams are taking on greater in-house responsibility for allaspects of recruitment, from study feasibility and site selection to patientgeneration and retention," Cohen said. "QuickTrainer teaches them how to put arecruitment lens on all of these processes."
The need for patient recruitment training is well-recognized throughoutthe clinical trials industry, affirmed by Kenneth Getz, senior research fellowfor the Tufts Center for the Study of Drug Development. "Study
