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Miami, Fl – January 29, 2010 –Dual enrollment occurs when a human research subject enrolls in overlapping clinical trials without meeting protocol required washout periods. Currently, researchers have no way to verify subject washout periods and are forced to rely on a subject’s word to evaluate this component of subject eligibility.
Because some subjects participate in early phase research as a way to earn money, researchers are concerned that an incentive exists for subjects to misrepresent the last time they received a study dose in order to become enrolled in an upcoming clinical trial.
In 2009, several unaffiliated clinical research institutions in South Florida joined together to create a subject registry called clinicalRSVP that proactively safeguards against dual enrollment. A neutral administrator was commissioned, and a Web-centric database capable of tracking subjects and their dose dates was created, resulting in a way for investigators to check if a subject was recently dosed before enrolling them to an upcoming clinical trial.
Since the launch of this network in October 2009, the 5 participating sites have registered over 1,500 subjects. As a result, these sites were able, on multiple occasions, to identify recently dosed subjects attempting to screen for an upcoming trial and fairly exclude them from participating. The five sites continue to use clinicalRSVP as a way to ensure trial accuracy and encourage other sites to join as a way to increase the effectiveness of the network.
ClinicalRSVP was developed and is administered by Independent Data Integrator (IDI), a company specializing in clinical database management. IDI worked closely with the South Florida sites, along with various legal advisors and institutional review board (IRB) experts to develop the clinicalRSVP program. Plans are underway to introduce additional networks in the Midwest and Northeast.