设计临床科研试验的主要原则
临床试验,,],临床试验；原则；试验分期；关键设计,1新药临床试验分期,2临床试验中的关键设计,参考文献：
[摘要] 随着医学的发展，新的药物和治疗方法不断涌现，在这些新药物和治疗方法中，有的有效，有的无效，有的甚至对人体有害。医生要为病人选择疗效好和副作用少的药物和方法，必须了解新药临床试验的概况，掌握疗效评价的原则。临床试验是一种医学研究的方法，属于实验性研究的范畴。通过成功的临床试验能科学的评价药物、疗法和预防性干预措施的效果及副作用，并使试验结果外推到总体病人或总体人群。现从临床流行病学角度谈谈设计临床试验的主要原则。[关键词] 临床试验；原则；试验分期；关键设计
Cardinal Principle of Design Clinical Research Test
LIU Bensong， WANG Zhisheng
(Fifteen Offtcers and Workers' Hospital of Huangshi, Huangshi， Hubei 435000, China)
Abstract:Along with the medicine development,the new medicines and methods of treatment are unceasingly emerged,in these new medicines and methods of treatment,some effectiveness,some invalidation;some is even harmful to the human body.Doctor must choose medicines and the methods for the patient with a curative effect to be good and few side effects,and must understand the survey of the new medicine in clinical test,grasps the principle of the curative effect appraisal.Clinical test is one medical research method,belongs to the category of the experimental research.Through the successful clinical test it can scientifically evaluate medicine,therapy and the effect and the side effect of preventive intervention measure,and makes the test result to extrapolate the general patient or the whole crowd.Presently it can be examined at the main principle of the design clinical test from the clinical epidemiology angle. ......
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