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DIA China 2021: Preparing for Unknown Risks in Exploratory Clinical Trials: Guideline from China CDE
New treatment areas including gene therapy, cell therapy, oncolytic virus, and proteolysis targeting chimera (PROTAC) products are growing into hotspots for early drug development in China. The recently issued Center for Drug Evaluation (CDE) Technical Guideline for the clinical trials of the oncolytic virus products emphasized methods of risk control in exploratory clinical trials for these products.