安微医科大学国际教育学院教案与讲稿 Parallel-group I group +A drug ◆Duration time II group +B drug I group +A drug I group +B drug Cross controlled Wash perind II group+B drug II group +A drug [Random design] 3min (1)Tossed Coin method and random table distribution method: (2)Random design method by statistics software,such as SPSS,DAS [Blinded trials 6min Blinded test:the doctor or the patient do not know which specific subjects is controlled or trial drug. Double-blind method test:Both the doctor and the patient Single blinding test:the patient Double-blind,double-dummy method Control drug (MTX tablet) Test drug (capsule) (MTX dummy) capsule dummy [The placebo] 6min Placebo means the substances that have no pharmacological activities,such as lactose,starch,etc. Placebo is used as a negative control in controlled clinical trial. The role of placebo in drug evaluation: 1)As the negative control,to evaluate new drugs to be security and effectiveness in blinded conditions; 2)Positive control,placebo are designed at the same time to supervise test methods sensitivity; 3)To exclude psychology factors in drug treatment, 4)To exclude the spontaneous change of disease. The indications of placebo 1)As negative control:to be used mainly the control of weak effect drugs. 2)To be used in the treatment of mild mental depression; 3)To be used for the patient,who don't need drug therapy; 4)To be used for chronic disease patient:the placebo can be used in drug treatment break. [Inclusion criteria of case l 2min 1)To determine selection criteria according to the professional requirements. 2)according to statistics requirements. 3)get informed consent form of the subjects. [Exclusion criteria of cases] 3min according to professional requirements: 5安徽医科大学国际教育学院教案与讲稿 5 [Random design] 3min (1) Tossed Coin method and random table distribution method: (2) Random design method by statistics software, such as SPSS, DAS. [Blinded trials] 6min Blinded test: the doctor or the patient do not know which specific subjects is controlled or trial drug. Double-blind method test: Both the doctor and the patient Single blinding test: the patient Double-blind , double-dummy method [The placebo] 6min Placebo means the substances that have no pharmacological activities, such as lactose, starch, etc. Placebo is used as a negative control in controlled clinical trial. The role of placebo in drug evaluation : 1）As the negative control, to evaluate new drugs to be security and effectiveness in blinded conditions; 2）Positive control, placebo are designed at the same time to supervise test methods sensitivity; 3）To exclude psychology factors in drug treatment; 4）To exclude the spontaneous change of disease. The indications of placebo 1) As negative control: to be used mainly the control of weak effect drugs. 2) To be used in the treatment of mild mental depression; 3) To be used for the patient, who don't need drug therapy; 4) To be used for chronic disease patient: the placebo can be used in drug treatment break. [Inclusion criteria of case ] 2min 1) To determine selection criteria according to the professional requirements. 2) according to statistics requirements. 3) get informed consent form of the subjects. [Exclusion criteria of cases] 3min according to professional requirements: Parallel-group Cross controlled I group +A drug II group + B drug Duration time I group +A drug II group + B drug Wash period I group +B drug II group + A drug Test drug（capsule） Control drug（MTX tablet） （MTX dummy） （ capsule dummy）