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¿Cuáles son las Fases de los Ensayos Clínicos? | MD Anderson Cancer Center
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Clínicos?</h1> </div> </section> <!-- ROW (1-COLUMN)--> <section class=" highlight " data-transition="fadeIn"> <div class="col-single table"> <div class="rte-container basic-content"> <p>Un tratamiento nuevo pasa por varias fases. Cada fase tiene un propósito diferente:</p> <ul> <li><span style="letter-spacing: -0.02em;">Ensayos de Fase I estudian si un tratamiento nuevo es seguro y busca el mejor modo de administrar el tratamiento. Los médicos también buscan signos de que el cáncer responde al tratamiento nuevo.</span></li> <li><span style="letter-spacing: -0.02em;">Ensayos de Fase II estudian si un tipo de cáncer responde al tratamiento nuevo.</span></li> <li><span style="letter-spacing: -0.02em;">Ensayos de Fase III estudian si un tratamiento nuevo es mejor que un tratamiento estándar.</span></li> <li><span style="letter-spacing: -0.02em;">Ensayos de Fase IV encuentran más información sobre los beneficios y efectos secundarios a largo plazo.</span></li> </ul> <p><span style="letter-spacing: -0.02em;">La mayoría de las veces, cuando usted participa en un ensayo clínico, usted sólo estará en una fase del estudio. Los tratamientos pasan por las fases, pero los pacientes no.</span><br> </p> </div> </div> </section> <!-- /ROW --> <section class="highlight" data-transition="fadeIn"> <div class="col-content-single"> <div class="module m-bleed"> <div class="accordion"> <div class="mda-accordion accordion-module"> <h3 class="panel-title ui-accordion-header"> <div> <span class="header-text">Ensayos de Fase I</span> <i class='fa fa-minus'></i> <i class='fa fa-plus'></i> </div> </h3> <div class="panel-container ui-accordion-content"> <div class="panel-content"> <div class="accordion-content-left accordion-content col12"> <div class="rte-container basic-content"> <p>Los médicos también encuentran el mejor modo de administrar el tratamiento. El objetivo de los ensayos de Fase I es:</p> <ul> <li><span style="letter-spacing: -0.02em;">Averiguar si un tratamiento es seguro.</span></li> <li><span style="letter-spacing: -0.02em;">Encontrar el mejor modo de administrar el tratamiento nuevo, como por ejemplo por boca o por vena.</span></li> <li><span style="letter-spacing: -0.02em;">Ver si hay signos de que el cáncer responde al tratamiento nuevo.</span></li> </ul> <p><span style="letter-spacing: -0.02em;">Los ensayos de Fase I normalmente incluyen de 15 a 30 pacientes que se dividen en grupos pequeños. Estos grupos se denominan cohortes. La primera cohorte recibe una dosis de una medicina nueva. Los médicos pueden tomar muestras de sangre u orina para medir los niveles de la medicina en los pacientes.</span><br> </p> <p><span style="letter-spacing: -0.02em;">Si la primera cohorte no tiene efectos secundarios severos, entonces una cohorte nueva recibe una dosis más alta de la misma medicina. La dosis aumenta con cada cohorte nueva, hasta que los médicos encuentran la mejor dosis para los estudios siguientes. Con cada aumento de dosis, los médicos hacen pruebas en cada paciente para ver si están respondiendo al tratamiento. </span><br> </p> <p><span style="letter-spacing: -0.02em;">Si los médicos encuentran que el tratamiento es seguro, entonces se avanza a estudios del tratamiento en ensayos de Fase II. </span><br> </p> <p><span style="letter-spacing: -0.02em;">El Clinical Center for Targeted Therapy ofrece muchos de los ensayos clínicos de Fase I en el MD Anderson. Pregunte a su médico si usted quiere saber más sobre este centro.</span><br> </p> </div> </div> </div> </div> <h3 class="panel-title ui-accordion-header"> <div> <span class="header-text">Ensayos de Fase II</span> <i class='fa fa-minus'></i> <i class='fa fa-plus'></i> </div> </h3> <div class="panel-container ui-accordion-content"> <div class="panel-content"> <div class="accordion-content-left accordion-content col12"> <div class="rte-container basic-content"> <p>Normalmente menos de 100 pacientes participan en los ensayos clínicos de Fase II. Incluso si el objetivo principal es ver si el tratamiento funciona, los médicos controlan aún muy de cerca los efectos secundarios de los pacientes. Si el tratamiento nuevo funciona, los médicos pueden continuar estudiándolo en ensayo clínico de Fase III.</p> </div> </div> </div> </div> <h3 class="panel-title ui-accordion-header"> <div> <span class="header-text">Ensayos de Fase III</span> <i class='fa fa-minus'></i> <i class='fa fa-plus'></i> </div> </h3> <div class="panel-container ui-accordion-content"> <div class="panel-content"> <div class="accordion-content-left accordion-content col12"> <div class="rte-container basic-content"> <p>Los ensayos de Fase III pueden incluir de cientos a miles de pacientes por todo el país o el mundo. Cada paciente inscrito en un ensayo clínico de Fase III tiene una probabilidad de estar en uno de los siguientes grupos:</p> <ul> <li><span style="letter-spacing: -0.02em;">Grupo de control – el grupo que recibe el tratamiento estándar</span></li> <li><span style="letter-spacing: -0.02em;">Grupo de estudio – el grupo que recibe el tratamiento nuevo que se está probando</span></li> </ul> <p><span style="letter-spacing: -0.02em;">Los médicos no saben si el tratamiento nuevo es mejor que el tratamiento estándar, pero ellos creen que es igual de bueno y quizás mejor.</span><br> </p> <p><strong><span style="letter-spacing: -0.02em;">¿Cómo se asignan los pacientes a los grupos?<br> </span></strong><span style="letter-spacing: -0.02em;">Una computadora decide cuales pacientes están en el grupo de control y cuales están en el grupo de estudio. Los pacientes tienen la posibilidad de estar en cualquier grupo. El paciente y el médico no deciden. Es aleatorio y se debe tan solo al azar. Esto ayuda a evitar sesgos en el ensayo clínico. (El sesgo ocurre cuando las opciones humanas afectan a los resultados de un estudio)</span></p> <p><strong><span style="letter-spacing: -0.02em;">¿Sabrá mi médico en qué grupo me encuentro yo?<br> </span></strong><span style="letter-spacing: -0.02em;">En los estudios ciego simple, los pacientes no saben si están o no están en el grupo de control o en el grupo de estudio, pero el médico si lo sabe. En los estudios doble ciego, ni los pacientes ni los médicos saben qué pacientes están en cada grupo. (En el caso de una emergencia, los médicos pueden encontrar esta información en el archivo del estudio.)</span></p> <p><span style="letter-spacing: -0.02em;"><strong>¿Me administrarán un placebo?<br> </strong>Un placebo es algo que se mira como una medicina, pero que no lo es. Si se usa un placebo, se administra conjuntamente con el mejor tratamiento estándar. Esto permite a los médicos comparar el tratamiento estándar por sí solo con el tratamiento estándar con una medicina nueva. Si no hay un tratamiento estándar, entonces se puede administrar el placebo sólo, pero esto no es común en los ensayos de cáncer. Después de los ensayos de Fase III, la FDA revisa los resultados clínicos para asegurarse de que el tratamiento es seguro y eficaz para el uso de las personas. La FDA decide si aprobar o no el tratamiento para que esté disponible para todos los pacientes.</span></p> </div> </div> </div> </div> <h3 class="panel-title ui-accordion-header"> <div> <span class="header-text">Ensayos de Fase IV</span> <i class='fa fa-minus'></i> <i class='fa fa-plus'></i> </div> </h3> <div class="panel-container ui-accordion-content"> <div class="panel-content"> <div class="accordion-content-left accordion-content col12"> <div class="rte-container basic-content"> <p>En los ensayos de Fase IV, los médicos estudian tratamientos que ya han sido aprobados por la FDA. El objetivo de los ensayos de Fase IV es continuar estudiando los efectos secundarios de un tratamiento nuevo.</p> </div> </div> </div> </div> </div> </div> </div> </div> </section> <section class="bleed-full" data-transition="fadeIn"> <div class="horizontal-text-bar blue"> <i class="mda-icon-international mda-stack-1x mda-inverse"></i> <div class="text-container"> <h3 class="title">Póngase en contacto con el International Center</h3> <div class="description"> <p><strong>Horario:</strong> Lunes - viernes, 8:00 - 17:00 p.m. (horario estándar central)<br/> <strong>Teléfono:</strong> 001-713-745-0450<br/> <strong>Número gratuito desde México y Canadá:</strong> <span class="nowrap">800-811-6167</span></p> </div> </div> <div class="cta-container"> <div class="cta"> <a href="mailto:international@mdanderson.org" class="cta-block" target="_self">Correo electrónico </a> </div> </div> </div> </section> </div> </div> </section> </div> <!--googleoff: all--> <div class="pre-footer"> <div 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