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ISSN 1561-3046 (Electronic)

2021, Number 1

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Rev Cub Med Mil 2021; 50 (1)

Approach to the state of the art of data monitoring committees in clinical trials

Pérez RS, Lara FHL, Arteaga CS, Rodríguez GMC, Tamayo RM

Language: Spanish
References: 32
Page:
PDF size: 223.06 Kb.


ABSTRACT

Introduction: For the first time, in 1967, a data monitoring committee was established in a study of cardiovascular mortality. Since then its use has increased, due to its value to guarantee the safety of subjects participating in clinical trials, the validity and integrity of the data. A documentary exploration of the last 20 years was carried out, on aspects related to the requirements for the creation and operation of data monitoring committees worldwide, with the aim of showing the development achieved in the establishment of data monitoring committees and identify its fundamental characteristics.
Development: There is an increase in documentary production on data monitoring committees, led by English speakers from developed countries, with a clear increase in publications on the subject, in the last five-year period, 50% higher than in the previous 15 years. This phenomenon is caused by the rise of the pharmaceutical and biotechnology industry, the high costs of drug research and development, the need to introduce new drugs and the increase in regulatory requirements. The structural characteristics, clinical and methodological requirements for the establishment of the committees are described.
Conclusions: There is a high development of data monitoring committees in clinical trials, with a tendency to increase their use in recent years. Data monitoring committees are characterized by clinical and methodological requirements for their establishment.


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