Wink Konrad
Medizinische Fakultät der Universität Freiburg/Brsg.
Arzneimittelforschung. 2008;58(9):475-9. doi: 10.1055/s-0031-1296542.
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 b e used, the besttherapy for the different stages can be ascertained.
为证明药物对慢性收缩性心力衰竭患者的疗效,在规划和开展药品临床研究时,考虑某些标准是必要的。对于不同阶段和患者群体,这些标准包括相应终点的定义、充分的研究设计、适当的随机分组、盲法、合适剂量的选择、有效的检查方法、正确的样本量估计和分析。如果使用这些标准,就能确定不同阶段的最佳治疗方法。