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New sampling, analysis method catches adverse effects with less burden

-- Lindsey Marcellin

Monday, October 11, 2010 (Last Updated: 10/12/2010)

MONDAY, Oct. 11 (HealthDay News) -- For phase III trials supporting supplemental drug applications, a more focused adverse event data collection strategy can effectively identify significant events, reduce the collection of unnecessary information, and decrease the burden of these large clinical trials, according to research published online Oct. 4 in the Journal of Clinical Oncology.

Lee D. Kaiser, of Genentech in South San Francisco, Calif., and colleagues used a new, prospectively developed statistical analysis plan to reanalyze post-marketing anticancer agent safety data -- often collected by pharmaceutical companies for studies that support supplemental indications of the new drug -- from eight previously completed prospective randomized trials. The purpose of the study was to assess the amount of safety data collected in these costly and complex studies and to determine an optimal method for collecting the most relevant safety data that would relieve the burden these studies place on the clinical trials infrastructure.

Studies reviewed documented 107,884 adverse events, of which four were grade 1 or grade 2 and nine grade were 3 and higher -- none of which had been included in the previously established safety profiles for the initial drug approval and which may have been missed using subsampling. Overall, the researchers concluded that collection of data on events serious enough to lead to dose modification/discontinuation or death should occur in all patients in the trial, that grade 3 or higher events should be collected from a subsample of the full trial, and that grade 1-2 events do not require collection.

"For phase III trials supporting supplemental applications, an optimized AE and concomitant medication collection strategy can identify clinically significant safety information and preserve resources otherwise spent collecting uninformative information. This optimized data collection strategy leads to a high probability of capturing events that matter most to patients and their physician," the authors write.

Many of the study authors disclosed financial relationships with the pharmaceutical industry.

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Editorial

Specialties Hematology & Oncology

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