The Research Of Risk And Benefit Assessment On Clinical Trials Of Newly-developed Drug Of Chinese Material Medica

Objective:To establish initially the ideas and methods of design and results evaluation on clinical trials of newly-developed drug of Chinese material medica based on the concept of risk-benefit assessment through clarifying the concept of the importance of the risk-benefit assessment for clinical trials of newly-developed drug of Chinese material medical, and show a demonstration.Methods:â‘ the literature and theoretical research:To analyze the status about clinical trials of newly-developed drug of Chinese material medica. arrange and summarize the relevant theoretical knowledge about the risk-benefit assessment, and extract the ideas and methods of design and results evaluation on clinical trials of newly-developed drug of Chinese material medica based on the concept of risk benefit assessment.â‘¡Demonstration research:study 1:To design the clinical trial protocol of newly-developed drug of Chinese material medical-Qiming granula. which will be used in treating diabetic retinopathy. Then analyze and evaluate the protocol by the ideas and methods. Study 2:To analyze and comprehensive evaluate the risk and benefit of the results of the completed Phaseâ…¢clinical trial of newly-developed drug of Chinese material medica which is compound freeze-dried injection.Results:â‘ Put forward the ideas and methods of design and result evaluation on clinical trials of newly-developed drug of Chinese material medica based on the concept of risk-benefit assessment:First, appropriate diseases and syndromes of adaptation, index of effect, control drugs, safety database, safety index and quality control measurement should be selected carefully based on the general principle of design on clinical trials of newly-developed drug of Chinese material medical, then the sufficient evidence could be provided. Second, propose the major issues and correlated evidence about benefit assessment, and important index or evidence about risk assessment during the course of result analysis about clinical trials.â‘¡Demonstration research:Study 1:Analyze the potential benefits and risks of the Qiming granula, and consider that the protocol of Qiming granula which will be used in treating diabetic retinopathy is in line with GCP principles, and reflect the advantages and characteristics of traditional Chinese medicine. Therefore the protocol has a very high reference effect for the design about clinical trials of newly-developed drug of Chinese material medica. Study 2:Analyze and comprehensive evaluate the risk and benefit of the results of the completed Phaseâ…¢clinical trials of the compound freeze-dried injection and discovered that the selected syndrome of adaptation is not appropriate. the relationship between the drug and shock's mortality rate is difficult to judge, and the quality control is not strict etc. All of these can't provide sufficient support for the security of the clinical trial. The risk-benefit assessment of this drug is not enough ideal, therefore it is difficult to convince the regulatory to approve registration.Conclusion:â‘ The concept of "risk-benefit" assessment should be throughout the whole process, including research, market, and eventually disappear from the market. Sponsor and clinical investigator should have the consciousness of the "risk-benefit" assessment, and the concept of dynamic risk-benefit assessment should be emphasized in clinical trails. In addition to efficacy and safety risks, we should consider other risks, such as design risk, ethics risk, research quality risks etc.â‘¡The sponsor or clinical investigator should have the ideas and methods when they design the clinical trials of newly-developed drug of Chinese material medica, which based on the concept of risk-benefit assessment. The ideas and methods can reflect the scientific nature, embody the advantages and characteristic of traditional Chinese medicine, and provide a sufficient safeguard for implementation and the results evaluation of the clinical trials. It also reflects the "people-oriented" essence of the clinical trials.â‘¢As a sponsor or clinical investigator, the ideas and methods of results evaluation on clinical trials of newly-developed drug of Chinese material medica based on the concept of risk-benefit assessment could be used to analyze and assess the benefit and risk of the completed clinical trials. And make preliminary judgments on the possibility of a newly-developed drug should be registered, or change the R & D strategy, or to stop the clinical trials in time which have large risk.