[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 b e used, the besttherapy for the different stages can be ascertained.
Wink
Konrad
K
Medizinische Fakultät der Universität Freiburg/Brsg. kwink@t-online.de
D002317:Cardiovascular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D002986:Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D054143:Heart Failure, Systolic / Q000188:drug therapy*; D006801:Humans; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
D002317:Cardiovascular Agents