University of Southern California (USC) researchers identified the challenge that often investigator-initiated trials (IITs) don’t have the same trial monitoring coverage as industry trials and addressed this gap by developing a self-study module that can be used to cross-train academic researchers in essential concepts and practical approaches to monitoring.
Investigator initiated trials are instrumental in translating academic research into medical product development. The USC team reports that only about 65% of IITs reported as being monitored—that leaves 35% of all IITs as not monitored—that represents a substantial volume of unmonitored research!
According to a CenterWatch report the number of IITs approached nearly 2,000 by 2002 and declined significant only to start increasing again to 615 by 2014. 836 Research (non-industry) INDs were received by the FDA in 2017. Of interest, ACRP produced a survey of current IITs practices in 2016.
Observed deficiencies in the quality control of these clinical trials can potentially lead to inadequacies in data accuracy and validity that could lead to significant delays in bringing innovative therapies to patients.
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