Search results for "Intermediate endpoint"
showing 2 items of 2 documents
Critères de substitution: méthodes de validation et état des lieux en cancérologie digestive
2009
In oncology, overall survival is often referred to as the gold standard for the evaluation of a novel therapy in phase III clinical trials. The use of an earlier endpoint (intermediate endpoint) would allow to reduce the duration, the number of patients and/or the cost of the studies. Before being used as primary endpoint, it has to be validated as surrogate for overall survival. Two main statistical methods have been developed. The first evaluates the proportion of treatment effect on overall survival that can be attributable to the effect on the surrogate endpoint. The second, the meta-analytic approach, estimates the correlation between the treatment effect on the surrogate and its effec…
Proteinuria-Microalbuminuria in Renal Damage
2015
Proteinuria (P) usually results from an insult in the glomerular and/or tubular structures of the kidney. It has been considered a marker of risk not only to develop renal insufficiency but also to suffer cardiovascular events, based on prospective studies carried out in the general population as well as in diabetic and hypertensive patients [1]. In fact, proteinuria has been considered a strong marker of risk and an intermediate endpoint during treatment [2, 3].