致癌性試驗主要用于評價新藥的潛在致癌性風(fēng)險，是安全性評價的重要內(nèi)容之一。新藥人體致癌性風(fēng)險目前主要依賴臨床前試驗結(jié)果來預(yù)測，以形成新藥臨床試驗和上市后的風(fēng)險控制計劃。致癌性試驗周期長，花費高，試驗設(shè)計和結(jié)果評價比較復(fù)雜，需要研究者和管理機構(gòu)加強交流溝通。

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.