第二章 新药开发研究与新药临床201109上课用.ppt

新药Ⅱ期临床药理学研究的四个基本原则： 代表性(representativeness) 合理性(rationality) 随机性(randomization) 重复性(replication) 二、Ⅱ期临床试验 新药Ⅱ期临床药理学研究的四个基本原则 代表性：指受试对象应按统计学中样本抽样，应符合总体规律的原则。 合理性：指试验设计既要符合专业要求与统计学要求，又要切实可行。 随机性：要求试验中两组患者的分配是均匀的，不随主观意志为转移。 重复性：目的是经得起重复验证，试验结果准确可靠。 Declaration of Helsinki Basic principles 7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits. 8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subjects freely-given informed consent, preferably in writing. Declaration of Helsinki Basic principles 10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship. 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the resp