<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0138-6557</journal-id>
<journal-title><![CDATA[Revista Cubana de Medicina Militar]]></journal-title>
<abbrev-journal-title><![CDATA[Rev Cub Med Mil]]></abbrev-journal-title>
<issn>0138-6557</issn>
<publisher>
<publisher-name><![CDATA[Centro Nacional de Información de Ciencias MédicasEditorial Ciencias Médicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0138-65572021000100017</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Aproximación al estado del arte de los comités de monitoreo de datos en ensayos clínicos]]></article-title>
<article-title xml:lang="en"><![CDATA[Approach to the state of the art of data monitoring committees in clinical trials]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pérez Rodríguez]]></surname>
<given-names><![CDATA[Sonia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lara Fernández]]></surname>
<given-names><![CDATA[Héctor Lázaro]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Arteaga Cantón]]></surname>
<given-names><![CDATA[Selma]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez González]]></surname>
<given-names><![CDATA[Meiby de la Caridad]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Tamayo Rodríguez]]></surname>
<given-names><![CDATA[Maura]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional de Toxicología  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Centro Nacional Coordinador de Ensayos Clínicos  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Instituto Finlay de Vacunas  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>03</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>03</month>
<year>2021</year>
</pub-date>
<volume>50</volume>
<numero>1</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S0138-65572021000100017&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S0138-65572021000100017&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S0138-65572021000100017&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción: En 1967 se estableció, por primera vez, un comité de monitoreo de datos, en un estudio de mortalidad cardiovascular; desde entonces su uso se ha incrementado debido a su valor para garantizar la seguridad de los sujetos participantes en ensayos clínicos y la validez e integridad de los datos. Se realizó una exploración documental de los últimos 20 años, sobre aspectos relacionados con los requisitos de creación y funcionamiento de los comités de monitoreo de datos a nivel mundial, con los objetivos de mostrar el desarrollo alcanzado en el establecimiento de los comités de monitoreo de datos e identificar sus características fundamentales.  Desarrollo: Existe un incremento en la producción documental sobre los comités de monitoreo de datos, liderado por angloparlantes de países desarrollados, con franco aumento de publicaciones sobre el tema en el último quinquenio, superior en 50 % a los 15 años anteriores. Este fenómeno lo provoca el auge de la industria farmacéutica y biotecnológica, los altos costos de investigación y desarrollo de medicamentos, la necesidad de introducir nuevos fármacos y el incremento de las exigencias regulatorias. Se describen las características estructurales, requisitos clínicos y metodológicos para el establecimiento de los comités.  Conclusiones: Existe alto desarrollo de los comités de monitoreo de datos en los ensayos clínicos, con tendencia al incremento de su uso en los últimos años. Los comités de monitoreo de datos se caracterizan por requerimientos clínicos y metodológicos para su establecimiento.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[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.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[comité de monitoreo de datos]]></kwd>
<kwd lng="es"><![CDATA[ensayo clínico]]></kwd>
<kwd lng="es"><![CDATA[buenas prácticas clínicas]]></kwd>
<kwd lng="en"><![CDATA[data monitoring committee]]></kwd>
<kwd lng="en"><![CDATA[clinical trial]]></kwd>
<kwd lng="en"><![CDATA[good clinical practices]]></kwd>
</kwd-group>
</article-meta>
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