Research On Risk Management During Clinical Trial Stage Of Biological Product R&D Project

The clinical trial is an important stage in biological product developing process, which is in order to provide scientific data supporting for validation of safety and reliability of biological product. It makes clinical trial more uncertain when lacking of knowledge and management of any risk, it can even lead to project failure in the severe case.Based on the activities feature and experience from clinical trial phase, this thesis primarily investigates the risk management in clinical trial phase for biological product Research and Development (R&D). Firstly introduce the study background, objective and connotation, study technical pathway, and brief summarize the current worldwide investigation status; Then introduce the relative concepts and theories for biological product R&D, risk management in clinical trials; Finally using risk management system knowledge, perform the relative risk identification, risk analysis & assessment and risk response strategy in clinical trial phase for biological product R&D, the main completed tasks are:(1) Application of ’Brainstorming method’ and’Work-Risk breakdown’, conduct risk identification via the uncertain elements from clinical trial. Firstly ten major risks and further detailed 39 risk elements were identified based on Work Breakdown Structure (WBS), set up the risks list which can be referred to clinical trial phase in my company biological product R&D.(2) Risk evaluation on individual risk possibility and impact level, setting-up P/I(Possibility/Impact) matrix and risk figure to prioritize their significance, summarize the risk elements with different levels in clinical trials.(3) Make appropriate response and control strategies for different level of risks based on risk evaluation result.This thesis applied the risk management theory and tools to clinical trial phase, using the risk figure to provide semi-quantification comments and define the primary risk response strategy, to have better scientific risk management works for the future biological product R&D clinical trials.