致癌性試驗(yàn)主要用于評(píng)價(jià)新藥的潛在致癌性風(fēng)險(xiǎn)，是安全性評(píng)價(jià)的重要內(nèi)容之一。新藥人體致癌性風(fēng)險(xiǎn)目前主要依賴臨床前試驗(yàn)結(jié)果來預(yù)測(cè)，以形成新藥臨床試驗(yàn)和上市后的風(fēng)險(xiǎn)控制計(jì)劃。致癌性試驗(yàn)周期長(zhǎng)，花費(fèi)高，試驗(yàn)設(shè)計(jì)和結(jié)果評(píng)價(jià)比較復(fù)雜，需要研究者和管理機(jī)構(gòu)加強(qiáng)交流溝通。

The objective of carcinogenicity study is to explore the potential carcinogenicity for new drugs, which is one of the important components of nonclinical safety evaluation. The potency of carcinogenic in human is evaluated with preclinical data, so as to make risk control plan for clinical trial and marketing. Carcinogenicity study usually needs long term with high costs, so it is better to make discussion within researcher and regulatory department.