PROGRESS OF THE INVESTIGATOR INITIATED TRIALS (IIT) IN KOREA

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Abstract

Clinical trials play a crucial role in developing novel cancer treatment strategies. Given the specific clinical traits of malignancies that are prevalent in Asia (i.e. lung adenocarcinoma, gastric cancer, liver cancer), it is imperative to actively develop clinical research program targeting for Asian cancer patients. Large proportion of trials for Asian prevalent cancers is carried out in the form of investigator-initiated trials since industry and investigators may have different interest or perspectives when designing clinical trials.

The cooperative network: supportive network for multi-center IITs in Korea: The representative cancer cooperative group in Korea is the Korean Cancer Study Group (KCSG), which is a nationwide cancer cooperative group consisting of 10 disease-specific subcommittees. One of the most important achievements by the KCSG was to establish infrastructure as well as education programs to support all phases of nationwide clinical trials. As of 2010, 66 trials are either completed or actively enrolling patients through KCSG, all of which were multi-institutional trials (enrolled nearly 5000 patients in KCSG trials). The Korean medical oncology society is enthusiastically striving to conduct more cooperative studies, which may not be limited to the nation, but to the Asian Pacific colleagues.

The multinational trials in Asian cancer populations: Based on several clinicopathological studies, Asian NSCLC patients have distinctive clinical and molecular profiles with high prevalence of never smokers and EGFR mutations, which are actively being reflected in current clinical developmental processes in NSCLC. Several clinical trials have investigated the impact of EGFR TKIs in Asian populations (i.e. IPASS trial). Moreover, several pivotal trials are multi-center IITs focused on Asian prevalent cancer types (i.e. gastric cancer (ARTIST trial), colorectal cancer (MYDAS trial), and biliary tract cancer (GEMOX-Tarceva trial) were all successfully conducted in Korea and/or pan-Asian region).

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