[Reading of the trials in cardiac insufficiency; preliminary and experimental studies (phases I-II)].
In addition to general consideration concerning the justification and methodology of therapeutic trials, the interpretation of the results of evaluation of new products in the field of cardiac failure poses a number of problems. In experimental studies in the animal, the choice of model of cardiac failure, the mode of evaluation of the parameters and the justification of the choice of dosage studied require particular attention. In preliminary clinical trials (Phases I and II), the choice and number of subjects, the dosage and methodology both for recensement and interpretation of data, are factors which influence the quality of the information obtained. When these studies have been completed, the decisions whether to develop the product and the recommended dosage have to be taken. The importance of these decisions justifies the extreme attention which has to be taken in the elaboration of these studies and in their interpretation.
Thuillez
C
C
Service de pharmacologie, CHU de Rouen.
D000818:Animals; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D012196:Review Literature as Topic
Lecture des essais dans l'insuffisance cardiaque; études expérimentales et préliminaires (phases I-II).