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Executive Summary

CLINICAL TRIAL ELECTRONIC COMPLIANCE MONITORS MIGHT DECREASE the overall costs of clinical trials by reducing the number of subjects needed to determine efficacy and compliance monitoring, a consultant told a May 24 seminar at FDA. Ex-Ortho research exec Martin Jeiven told FDA that while compliance monitors add to the initial cost of a study, they have the potential for "decreasing the number of patients you [must] put into a clinical trial if you control what's happening with fewer patients." The technology, which incorporates a computer chip into a vial's cap to record the time of day the vial is opened, costs $7 per month to rent, "and a report costs $75 to generate," the consultant continued. "It would be a lot of money if you used 1,000 or 2,000 of these in a study, but I'm not so sure you would need that kind of number if you know what's happening with the patients," Jeiven said. "I think the problem is that we don't know what's happening in large, multicenter trials." A monitoring device has been fitted to Ortho's oral contraceptive dial packs and modified to record the time each tablet is dispensed, Jeiven pointed out. The consultant worked for Ortho from 1982 until last January. The technology can be modified for blister packs and tubes of creams or ointments. Asked whether the technology could be used in marketed products to help physicians improve patient compliance with drug regimens, Jeiven replied that one manufacturer of the device, Aprex, considers "that this has a place" for selective marketed products. Such products, he suggested, might include: "drugs that have a narrow margin of safety" -- like lithium and Coumadin (warfarin); "drugs that have to be titrated"; and life-saving products. If placed on a dial-pack of oral contraceptives, the device "could well add about $25 or $30 to the initial cost," he noted, but "the battery life is two years" so that the added monthly cost is just over $1.

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