Endpoints and patient stratification in ...
Type de document :
Article dans une revue scientifique
PMID :
URL permanente :
Titre :
Endpoints and patient stratification in clinical trials for alcoholic hepatitis
Auteur(s) :
Mathurin, Philippe [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Thursz, Mark Richard [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Thursz, Mark Richard [Auteur]
Titre de la revue :
Journal of hepatology
Nom court de la revue :
J. Hepatol.
Numéro :
70
Pagination :
314-318
Date de publication :
2019-02-01
ISSN :
0168-8278
Mot(s)-clé(s) en anglais :
GAHS
Surrogate endpoints
Infection
MELD
ABIC
Surrogate endpoints
Infection
MELD
ABIC
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
In some areas of medicine the clinical development pathway through phase II and III clinical trials has been well mapped out and refined through extensive experience. In contrast, a number of key questions remain unanswered ...
Lire la suite >In some areas of medicine the clinical development pathway through phase II and III clinical trials has been well mapped out and refined through extensive experience. In contrast, a number of key questions remain unanswered in the development of novel therapeutics for alcoholic hepatitis. The use of mortality as an endpoint in phase II clinical trials will potentially restrict the appeal of this therapeutic area for pharmaceutical companies, as the number of patients required for adequately powered clinical trials becomes impractical. Herein, we discuss alternative endpoints and conclude that dynamic assessment of liver function is the most pragmatic option in early stage studies. Stratification based on disease severity should be applied to avoid uneven distribution of patients with substantially differing mortality risks. Consensus on early phase trial design would help to facilitate new therapeutic development in this area of high unmet medical need.Lire moins >
Lire la suite >In some areas of medicine the clinical development pathway through phase II and III clinical trials has been well mapped out and refined through extensive experience. In contrast, a number of key questions remain unanswered in the development of novel therapeutics for alcoholic hepatitis. The use of mortality as an endpoint in phase II clinical trials will potentially restrict the appeal of this therapeutic area for pharmaceutical companies, as the number of patients required for adequately powered clinical trials becomes impractical. Herein, we discuss alternative endpoints and conclude that dynamic assessment of liver function is the most pragmatic option in early stage studies. Stratification based on disease severity should be applied to avoid uneven distribution of patients with substantially differing mortality risks. Consensus on early phase trial design would help to facilitate new therapeutic development in this area of high unmet medical need.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
CHU Lille
Inserm
Université de Lille
Inserm
Université de Lille
Date de dépôt :
2019-10-22T07:44:13Z
2023-12-01T15:38:42Z
2023-12-01T15:38:42Z