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ObjectiveThe aim is to construct an evaluation framework for clinical research benefits， and provide a reference for the formulate of evaluation standards for clinical research benefits. MethodsThe Delphi method was used to carry out expert consultation， and the mean， score of importance， coefficient of variation and coordination， etc. of evaluation indicators were summarized and calculated， to screen evaluation indicators for clinical research benefits. ResultsTwenty-three experts in this field were selected for correspondence， and their enthusiasm was 100% in both rounds， the authority coefficients were≥0.90， and Kendall’s coefficients of concordance were<0.25 （P<0.001）. By referring to the mean and coefficient of variation of the indicators， as well as combining them with expert suggestions， an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators， 5 secondary indicators， and 8 tertiary indicators. ConclusionThe evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits， as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.
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【Objective:】 To deeply understand the current situation and hotspots of drug clinical trials risk management in China. 【Methods:】 Co-word analysis and social network analysis were used to sort out the study results of risk management in drug clinical trials in China. 【Results:】 The trend of risk research of drug clinical trials in China was generally on the rise. The research hotspots focused on four areas: drug supervision and pharmacovigilance, risk management of drug clinical trial institutions, ethical review of drug clinical trials, and risk management of drug clinical trials. 【Conclusion:】 In the future, China should gradually improve the risk management system and supervision system of drug clinical trials, explore to establish a risk-based quality management and ethical review system of drug clinical trials, and enhance the risk assessment and coping ability of institutions.
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【Objective:】 To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China. 【Methods:】 The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China, and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks. 【Results:】 The risk categories of drug clinical trials were divided into 5 parts, namely drug clinical trial institution management, ethics committee management, clinical trial designs, researchers, and subjects, involving 13 main risk influencing factors and 21 specific risk points. 【Conclusion:】 By strengthening the construction of drug clinical trial institutions and ethical management capabilities, optimizing research protocol design, enhancing researchers’ awareness and ability, and establishing a subject management system to improve the quality of drug clinical trials.
RESUMEN
Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.