CAJ | 학술논문

采用数理统计方法，对药物研发中可能产生的伦理问题进行实证分析，发现药物研发实验中的伦理问题表现为误用统计方法进行数据的合理性分析，致使数据失真；人为操作失误导致异常数据，发表不实数据资料；实验设计不科学导致数据不可靠，致使数据产生偏差。药物研发实验中实验数据和实验设计的伦理问题极为重要。建议将伦理学研究前移至药物研发的设计过程之中，通过电子化管理实验数据、改进和优化实验设计方法、采用虚拟实验和计算机模拟等现代化手段，以及确保实验数据完整性等措施，有效防范伦理问题的发生。
채용수리통계방법，대약물연발중가능산생적윤리문제진행실증분석，발현약물연발실험중적윤리문제표현위오용통계방법진행수거적합이성분석，치사수거실진；인위조작실오도치이상수거，발표불실수거자료；실험설계불과학도치수거불가고，치사수거산생편차。약물연발실험중실험수거화실험설계적윤리문제겁위중요。건의장윤리학연구전이지약물연발적설계과정지중，통과전자화관리실험수거、개진화우화실험설계방법、채용허의실험화계산궤모의등현대화수단，이급학보실험수거완정성등조시，유효방범윤리문제적발생。
To analyze the ethical issues in the experiments of drug research and development ,an empirical study was conducted with the mathematical statistics method .Ethical issues in the experiments of drug research and development embody mainly in three aspects :data distortion by misuse of statistical methods ;unrealistic data by human errors in operation and bias data by unscientific design of the experiments .Ethical issues related to experimental data and design in drug research and development are of vital significance .Therefore ,it suggested that ethical research should be shifted forward into the design of drug research and development .Some measures ,such as digital management of experimental data ,optimized experimental design ,virtual experiments ,computer simulation and experimental data integrity should be taken into consideration .