Instructions and Methods for Clinical Trials of Medicinal Products for the Treatment of Chronic Systolic Heart Failure

被引:0
|
作者
Wink, Konrad [1 ]
机构
[1] Univ Freiburg Brsg, Fak Med, Freiburg, Germany
来源
ARZNEIMITTELFORSCHUNG-DRUG RESEARCH | 2008年 / 58卷 / 09期
关键词
Clinical trials; criteria; Efficacy and safety; Heart failure; chronic systolic; Medicinal products; criteria for clinical trials;
D O I
暂无
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Instructions and Methods for Clinical Trials of Medicinal Products for the Treatment of Chronic Systolic Heart Failure To prove the efficacy of drugs in patients with chronic systolic heart failure, taking into consideration certain criteria is necessary for the planning and performance of the clinical investigation of medicinal products. For the different stages and the collective of patients those criteria include the definition of the corresponding endpoints, adequate study design, appropriate randomisation, blinding, the choice of an appropriate dose, valid methods of examination, the correct sample size estimation and analysis. If these criteria will be used, the best therapy for the different stages can be ascertained.
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页码:475 / 479
页数:5
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