DMC reports in the 21st century: towards better tools for decision-making.
Trials
; 24(1): 289, 2023 Apr 21.
Article
en En
| MEDLINE
| ID: mdl-37085883
ABSTRACT
Data Monitoring Committees (DMCs) have the important task to protect the safety of current and future patients during the conduct of a clinical study. Unfortunately, their work is often made difficult by voluminous DMC reports that are poorly structured and difficult to digest. In this article, we suggest improved solutions. Starting from a principled approach and building upon previous proposals, we offer concrete and easily understood displays, including related computer code. While leveraging modern tools, the most important is that these displays support the DMC's workflow in answering the relevant questions of interest. We hope that the adoption of these proposals can ease the task of DMCs, and importantly, lead to better decision-making for the benefit of patients.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Comités de Monitoreo de Datos de Ensayos Clínicos
/
Toma de Decisiones Clínicas
Tipo de estudio:
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Suiza