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Objective:To discuss the scientificity and feasibility of risk-based monitoring strategies in Investigator initiated Trials.Methods:" Guideline for Good Clinical Practice" promulgated by NMPA, " Oversight of Clinical Investigations-a Risk-based Approach to Monitoring" and " A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry DRAFT GUIDANCE" promulgated by the US FDA and other documents were analyzed, the practical experience of Investigator initiated Trials was also summarized.Results:It was recommended that clinical investigators use risk-based monitoring strategies in Investigator initiated Trials. The main idea of risk-based monitoring is to determine the key process and key data of the study, carry out risk rating on the project, and adopt corresponding monitoring methods according to the risk level when formulating the monitoring plan. At the same time, during the clinical trial development process, the risk and data quality of the research center should be regularly evaluated to grasp the risk changes of different centers. In accordance with trends, adjust the method, content and frequency of monitoring.Conclusions:To apply risk-based monitoring strategies in Investigator initiated Trials is scientificity and feasibility. Risk based monitoring can meet the data quality requirements of clinical trials, without affecting the analysis results of the main outcomes, and can further improve the efficiency and effectiveness of monitoring.
ABSTRACT
Objective:Discuss the problems of multi-center pharmaceutical clinical trial which initiated by investigator (IIT), providing references for developing study management strategies.Methods:By analyzing the site recruitment, academic and ethical review, study contract, study training, quality control, influencing factors of subject enrollment, proposed management strategies of multi-center pharmaceutical clinical study which initiated by investigator.Results:While conducting multi-center pharmaceutical clinical study initiated by investigator, the study experiences, study team, hospital equipment, and the internal process of hospitals are the factors which ensure the progress and quality of clinical study. Most of the sites have no clear statement of scientific review, but most of the high-level hospitals do not use the ethical review results of the head hospitals, the ethics must be reviewed repeatedly; Contract also has different requirements due to different management departments. During the preparation and implement of IIT, the investigators should undergo a rigorous training which is a key element to ensure the quality of the study. Research quality and progress restrict each other and are affected by many factors, detailed quality control measures should be developed, training and inspection, and the cooperation of project management and data management, also with discover the data problems of sites and communicate with investigators timely to ensure the improvement measures are implemented.Conclusions:There are many factors have impact on study progress and quality of multi-center pharmaceutical clinical trial of IIT. Before conducting research, protocols should be developed scientifically, and fully assessing its feasibility, screening study sites strictly, shorten the time of ethical review and contract preparation. Study training, inspection, data management, risk management and document management should be implement strictly, and make full use of information platforms and means, improve management efficiency and IIT progress and quality.