Experiences and challenges in data monitoring for clinical trials within an international tropical disease research network.
Clin Trials
; 3(5): 469-77, 2006.
Article
en En
| MEDLINE
| ID: mdl-17060220
ABSTRACT
BACKGROUND:
Models for the structure and procedures of data and safety monitoring boards (DSMBs) continue to evolve in response to issues of new and of old concern. Some authors have called for an open dialogue on these questions through publication of the experiences of DSMBs in addressing them.PURPOSE:
The goal of this paper is to add to the current discussion about acceptable models for establishing, serving on, and reporting to monitoring committees, particularly those that oversee multiple studies in less developed countries. The paper seeks to do so by describing the establishment and subsequent operation of one such multi-trial DSMB over a five-year period. This DSMB was formed to monitor trials conducted by members of the International Centers for Tropical Disease Research (ICTDR) network of the National Institute of Allergy and Infectious Diseases (NIAID).METHODS:
The operational model and experiences are summarized by the authors, who had immediate responsibilities for directing the DSMB's activities.RESULTS:
The board played an active, traditional role in assuring that patient safety was maintained and that current standards for clinical research were met. In addition, both NIAID and the board members viewed education of investigators to be an important role for the board to play in this particular setting. This affected the threshold for identifying which trials would be monitored, and it impacted several procedures adopted by the board.LIMITATIONS:
This report reflects the observations of those involved in managing the DSMB, including comments offered by the DSMB and by investigators, but not data gathered in a systematic way.CONCLUSIONS:
The operational model described here has allowed the DSMB to fulfill its role in the oversight of the trials. We hope that the ideas we present may help others facing similar situations and may stimulate further critical thinking about DSMB structure and function.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Medicina Tropical
/
Ensayos Clínicos como Asunto
/
Modelos Organizacionales
/
Comités de Monitoreo de Datos de Ensayos Clínicos
Tipo de estudio:
Guideline
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Clin Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2006
Tipo del documento:
Article
País de afiliación:
Estados Unidos