<?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>1996-3521</journal-id>
<journal-title><![CDATA[Infodir]]></journal-title>
<abbrev-journal-title><![CDATA[Infodir]]></abbrev-journal-title>
<issn>1996-3521</issn>
<publisher>
<publisher-name><![CDATA[Editorial de Ciencias Médicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1996-35212021000300006</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Desarrollo de los ensayos clínicos en el Hospital General &#8220;Dr. Juan Bruno Zayas Alfonso&#8221;]]></article-title>
<article-title xml:lang="en"><![CDATA[Development of clinical trials at &#8220;Dr. Juan Bruno Zayas Alfonso General Hospital&#8221;]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Marañón Cardonne]]></surname>
<given-names><![CDATA[Tatiana]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Griñán Semanat]]></surname>
<given-names><![CDATA[Dianne Yurien]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Landazuri Llago]]></surname>
<given-names><![CDATA[Sanlia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vaillant Lora]]></surname>
<given-names><![CDATA[Llilian Dangelis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Poulut Durades]]></surname>
<given-names><![CDATA[Tania Margarita]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de Ciencias Médicas de Santiago de Cuba Hospital General &#8220;Dr. Juan Bruno Zayas&#8221; ]]></institution>
<addr-line><![CDATA[ Santiago de Cuba]]></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>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2021</year>
</pub-date>
<numero>36</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1996-35212021000300006&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1996-35212021000300006&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1996-35212021000300006&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción: En el año 1998 el Hospital General &#8220;Dr. Juan Bruno Zayas Alfonso&#8221; de Santiago de Cuba se inserta en la red Nacional de Ensayos Clínicos. El Certificado en Buenas Prácticas Clínicas desde el 2011 ha contribuido al registro sanitario de nuevos productos y su posterior comercialización.  Objetivo:  Describir la experiencia adquirida y el desarrollo alcanzado por el Hospital General &#8220;Dr. Juan Bruno Zayas Alfonso&#8221; en la ejecución de protocolos de ensayo clínico multicéntricos.  Métodos: Se realizó un estudio descriptivo sobre la ejecución de ensayos clínicos realizados en el Hospital General &#8220;Dr. Juan Bruno Zayas Alfonso&#8221; desde el año 2005 hasta diciembre de 2020. Se analizaron las variables: centro promotor, producto evaluado, fase del ensayo clínico, especialidades médicas, principales indicaciones, pacientes incluidos e investigadores.  Resultados: Se ejecutaron 39 ensayos clínicos, fundamentalmente fase II, III, IV, de desarrollo de medicamentos, procedentes del Centro de Inmunología Molecular y el Centro de Ingeniería Genética y Biotecnología en su mayoría. En enfermedades oncológicas 23 (58,9 %) y 16 (41 %) investigaciones en diversas indicaciones no oncológicas. Los productos de investigación más utilizados han sido, CIMAvaxEGF, nimotuzumab, supositorios de estreptoquinasa (proctoquinasa) y eritropoyetina. Se destacó las especialidades de oncología y neumología con la ejecución de 10 (25,6 %) y 5 (12,8 %) ensayos respectivamente. Fueron incluidos 474 pacientes y participaron 109 investigadores.  Conclusiones: El Hospital General &#8220;Dr. Juan Bruno Zayas Alfonso&#8221;, ha mantenido un trabajo sistemático en la ejecución de ensayos clínicos multicéntricos y contribuidos al registro sanitario de varios productos farmacéuticos.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction:  In 1998 "Dr. Juan Bruno Zayas Alfonso" General Hospital in Santiago de Cuba was inserted in the National Clinical Trials network. The Good Clinical Practices Certificate since 2011 has contributed to the sanitary registration of new products and their subsequent commercialization.  Objective:  To describe the experience acquired and the development achieved by the General Hospital "Dr. Juan Bruno Zayas Alfonso" in the execution of multicenter clinical trial protocols.  Methods:  A descriptive study was conducted on the execution of clinical trials carried out at the "Dr. Juan Bruno Zayas Alfonso" General Hospital from 2005 to December 2020. The following variables were analyzed: promoting center, product evaluated, phase of the clinical trial, medical specialties, main indications, patients included and investigators.  Results:  Thirty-nine clinical trials were carried out, mainly phase II, III and IV drug development trials, mostly from Center for Molecular Immunology and the Center for Genetic Engineering and Biotechnology. In oncological diseases, 23 (58.9 %) and 16 (41 %) investigations in various non-oncological indications were performed. The most used research products were CIMAvaxEGF, nimotuzumab, streptokinase (proctokinase) suppositories and erythropoietin. The specialties of oncology and pneumology stood out with the execution of 10 (25.6 %) and 5 (12.8 %) trials, respectively. A total of 474 patients were included and 109 investigators participated.  Conclusions:  The General Hospital "Dr. Juan Bruno Zayas Alfonso", has maintained a systematic work in the execution of multicenter clinical trials and contributed to the sanitary registration of several pharmaceutical products.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[ensayo clínico]]></kwd>
<kwd lng="es"><![CDATA[buenas prácticas clínicas]]></kwd>
<kwd lng="es"><![CDATA[Cuba]]></kwd>
<kwd lng="en"><![CDATA[clinical trial]]></kwd>
<kwd lng="en"><![CDATA[Good Clinical Practices]]></kwd>
<kwd lng="en"><![CDATA[Cuba]]></kwd>
</kwd-group>
</article-meta>
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