Independent Data Monitoring Committees: Review of Current Guidelines
Korean Journal of Clinical Pharmacy
;
: 181-186, 2016.
Artigo
em Coreano
| WPRIM
| ID: wpr-63695
ABSTRACT
BACKGROUND:
There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years.METHODS:
It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail.RESULTS:
IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making.CONCLUSION:
IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Comitês de Monitoramento de Dados de Ensaios Clínicos
/
Europa (Continente)
/
Coreia (Geográfico)
Tipo de estudo:
Ensaio Clínico Controlado
/
Guia de Prática Clínica
/
Estudo prognóstico
Limite:
Humanos
País/Região como assunto:
Ásia
/
Europa
Idioma:
Coreano
Revista:
Korean Journal of Clinical Pharmacy
Ano de publicação:
2016
Tipo de documento:
Artigo
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