Cognitive Go/No-Go decision-making criteria in Alzheimer's disease drug development.
Drug Discov Today
; 26(5): 1330-1336, 2021 05.
Article
en En
| MEDLINE
| ID: mdl-33486115
ABSTRACT
Go/No-Go decision making in early phase clinical trials is challenging for drug developers working in Alzheimer's disease. Recent negative trial results have been attributed to a lack of efficacy and important safety concerns. Furthermore, demonstrated target engagement has rarely translated into demonstrable clinical efficacy. Cognitive data might provide valuable insights at various points during drug development, and a thoughtful and robust set of decision-making criteria, specified a priori, can and should be applied under many circumstances. This review provides insights into how to utilize cognitive data for Go/No-Go decisions, with an emphasis on how these cognitive criteria differ depending on the context (e.g., stage of development, mechanism of action and trial design).
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Toma de Decisiones
/
Enfermedad de Alzheimer
/
Desarrollo de Medicamentos
Tipo de estudio:
Prognostic_studies
Límite:
Animals
/
Humans
Idioma:
En
Revista:
Drug Discov Today
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2021
Tipo del documento:
Article