| Abstract: | It has been well recognized that investigator-initiated academic clinical trials is an important component in developing practice-changing cancer treatment, for instances, FOLFIRINOX in metastatic and resectable pancreatic cancer and FLOT in locally advanced gastric cancer. Because of the difference in prevalent cancer types, pharmacogenomics, tumor biology and/or associated genetic alterations, and new drug approval/reimbursement, clinical practice pattern and subsequent patient outcomes between Eastern and Western populations, the role for such academic clinical intervention trials, including real-world data (RWD) collection registration trials, to investigate the safety and efficacy of repurposing or new agents for new indications evaluation is even more relevant in Asia. Facing the rapid advances in modern biotechnology and biomarker-enriched molecular targeted/immunotherapy, multi-national intergroup study is an attractive model to collect sufficient patients or data in a reasonable period of time for non-industry sponsored trials. Taiwan Cooperative Oncology Group (TCOG) is a government funding supported organization with extensive domestic, multicenter trial experience. However, international collaborative academic trials are much more challenging. From our previous experience, hurdles existed, such as, ethical and privacy protection issue of real world data sharing, funding and medication availability issues for intervention trials, translational tissue acquisition, storage and usage and NGS issue for biomarker-driven trials, etc. The real-world cases will be presented in the meeting! |
