Exploration of Consideration for Compassionate Use in China Based on a Survey of Current Cognition
Objective:To explore the cognitive status and understanding of professionals related to clinical trials based on compassionate use experiences in China and the United States.It provides suggestions for refining and improving China's compassionate use system to better meet patients'clinical needs.Methods:Non-probability sampling methods,such as voluntary and convenience sampling,are used.A questionnaire survey is conducted with professionals related to clinical trials,focusing on their cognition and understanding of the applicable conditions of compassionate use,the application and review subjects,patient safety management,and the approval process.Results:A total of 740 valid questionnaires are collected.Survey results shows that the awareness of Chinese clinical trial practitioners on compassionate use in China needs to be improved.There are commonalities and differences in cognition and understanding between enterprise practitioners and institutional practitioners.Commonalities are mainly reflected in their cognition of the population suitable for compassionate use,the review subject of applications for compassionate use to the National Medical Products Administration,parties responsible for patient adverse event reporting,places for compassionate use,and fee issues.Differences exist in drug conditions,application subjects,compensation for adverse events during compassionate use,and the FDA's approval process for compassionate use of individual patients in emergency situations and medium-sized patients in non-emergency situations.Conclusion:Clinical trial practitioners in China have a significant lack of understanding of the country's compassionate use system.Survey results suggest that clinical trial practitioners in different roles have varying levels of understanding of drug conditions,applicants,patient safety management,and approval processes for compassionate use in China.Further policy advocacy work is recommended to guide more qualified enterprises to carry out compassionate use programs to benefit more potential patients.In addition,the content of understanding that shows significant differences needs further clarification,refinement,and improvement.
compassionate useextended clinical trialscognitionapplicable conditionsapplication and review subjectssafety managementapproval process
万方数据
维普
