2016 Volume 6 Issue 3 Pages 269-280
Background : In 2016, the U. S. Food and Drug Administration issued a guidance entitled “Determining the extent of safety data collection needed in late-stage premarket and postapproval clinical investigations.” The approach this guidance proposes leads to reductions in costs and work time and may improve the quality of the study database. We evaluated the applicability of selective data collection for oncology drugs. Methods : Review reports of oncology drugs for Japanese new drug applications issued by PMDA were used for the present study. The frequencies of adverse events observed in the pivotal studies were paired and compared between the first approval and the supplemental approval. Paired studies were categorized into four groups ; A) same tumor type and same usage, B) same tumor type and different usage, C) different tumor type and same usage, D) different tumor type and different usage. Results : 31 study pairs that had obtained additional indications between 2009 and 2014 were investigated. In group A, all 5 pairs showed high correlation coefficients : r=0.8199, 0.7844, 0.7399, 0.7345, and 0.6370. Conclusions : Selective data collection should be adopted in cases in which the additional indication is for the same tumor type and usage as the first or previous indication.
