Drug development of nonalcoholic fatty liver disease: challenges in research, regulatory pathways, and study endpoints.
Expert Opin Drug Discov
; 16(2): 125-134, 2021 02.
Article
em En
| MEDLINE
| ID: mdl-33086894
ABSTRACT
INTRODUCTION:
The growing prevalence of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and its association with obesity as a metabolic disease contributes to harmful outcomes and healthcare resource burden worldwide. For this reason, there is an urgent need to develop new therapies. Identification of treatment targets, research design, endpoints definitions and assessments, and supportive regulatory pathways for drug approval all play prominent roles in shaping efforts in drug discovery, investigation, and approval. AREAS COVERED In this perspective, the authors enumerate key challenges of NAFLD clinical research and offer a conceptual framework to address these issues which arise during clinical trials. EXPERT OPINION With the anticipated significant healthcare and costs burden that NAFLD will impose throughout the world, the diagnostics and drug development processes need to be accelerated. Important measures to improve clinical trial research include standardization of case definitions, comprehensive and granular covariate data collection, quality study development incorporating novel trial designs, and quality data reporting. The authors believe that these actions will accelerate understanding, development, and ultimately approval of efficacious treatments.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Aprovação de Drogas
/
Hepatopatia Gordurosa não Alcoólica
/
Desenvolvimento de Medicamentos
Tipo de estudo:
Prognostic_studies
/
Risk_factors_studies
Limite:
Animals
/
Humans
Idioma:
En
Revista:
Expert Opin Drug Discov
Ano de publicação:
2021
Tipo de documento:
Article