123IN - Phase I Cancer Drug Development in China

Abstract

ABSTRACT Phase I clinical studies in China In China, registration trials can only be performed in around 200 hospitals which are certificated by SFDA. Among these institutions, around 50% of them can perform cancer related studies. There are not more than 10 centers dedicating cancer related phase I study. Most of active sites are located in big cities. Due to the regulation that: “the first in human trial is not allowed in China if the compound is produced outside China”, only 9 new compounds were approved for Phase I trials in China in 2011. Many studies indicate that the genomic profile of Asian may be different with that of Caucasian. And now, the cancer related trials are more and more rely on biomarker enrichment cohort trials. Due to these 2 reasons, Chinese patients need early phase trials than before. Bioinformatics will play essential role in integrating different levels of information from metabonomics, trancriptomics, proteinomics and genomics to form the whole picture of disease. And phase I trial with all these information can be very important for the clinical development of drugs. Disclosure: The author has declared no conflicts of interest.