{"id":116481,"date":"2018-03-11T10:45:35","date_gmt":"2018-03-11T10:45:35","guid":{"rendered":"https:\/\/www.deberes.net\/tesis\/sin-categoria\/la-participacion-de-los-menores-de-edad-en-los-ensayos-cla%c2%adnicos-de-la-region-de-murcia-consideraciones-etico-legales\/"},"modified":"2018-03-11T10:45:35","modified_gmt":"2018-03-11T10:45:35","slug":"la-participacion-de-los-menores-de-edad-en-los-ensayos-cla%c2%adnicos-de-la-region-de-murcia-consideraciones-etico-legales","status":"publish","type":"post","link":"https:\/\/www.deberes.net\/tesis\/pediatria\/la-participacion-de-los-menores-de-edad-en-los-ensayos-cla%c2%adnicos-de-la-region-de-murcia-consideraciones-etico-legales\/","title":{"rendered":"La participaci\u00f3n de los menores de edad en los ensayos cl\u00ednicos de la regi\u00f3n de murcia: consideraciones \u00e9tico-legales"},"content":{"rendered":"

Tesis doctoral de Pablo Vigueras Paredes <\/strong><\/h2>\n

Objetivos: analizar el nivel de cumplimiento de los principales requisitos \u00e9tico-legales en los ensayos cl\u00ednicos pedi\u00e1tricos evaluados en la regi\u00f3n de murcia durante los a\u00f1os 2006-2012; realizar una lectura cr\u00edtica entre la teor\u00eda y pr\u00e1ctica, destacando aqu\u00e9llos puntos problem\u00e1ticos en su aplicaci\u00f3n y elaborar propuestas de mejora en la evaluaci\u00f3n de los ensayos cl\u00ednicos pedi\u00e1tricos. metodolog\u00eda: estudio descriptivo que tiene por objeto analizar determinadas variables objetivas relacionadas con los aspectos metodol\u00f3gicos, legales y \u00e9ticos de los ensayos cl\u00ednicos pedi\u00e1tricos. La obtenci\u00f3n de la informaci\u00f3n necesaria para el desarrollo de la investigaci\u00f3n se ha realizado mediante el an\u00e1lisis de los protocolos y hojas de informaci\u00f3n al paciente de los ensayos cl\u00ednicos pedi\u00e1tricos con medicamentos existentes en el comit\u00e9 \u00e9tico de investigaci\u00f3n cl\u00ednica del \u00e1rea i (murcia-oeste). resultados: el n\u00famero de ensayos cl\u00ednicos pedi\u00e1tricos con medicamentos realizados en la regi\u00f3n de murcia se encuentra dentro de la media nacional y europea (10% del total de ensayos realizados). Prevalecen los estudios en oncohematolog\u00eda pedi\u00e1trica y neuropediatr\u00eda. El prototipo de ensayo cl\u00ednico realizado en la regi\u00f3n de murcia es el estudio fase ii-iii, doble ciego, controlado, paralelo, multic\u00e9ntrico, y con una duraci\u00f3n entre 1 y 3 a\u00f1os, financiados por la industria farmac\u00e9utica en un 50% de los supuestos, con preponderancia de estudios frente a placebo superior a la media (37,5%) y con un beneficio potencial indirecto para la poblaci\u00f3n investigada (83,3%). En un 38,5% de los ensayos analizados, no se especifica, el derecho del paciente a consultar y reflexionar con aquellas personas que desee. En un 87,5% de los ensayos no existe cl\u00e1usula de revocaci\u00f3n. No se fija con claridad el derecho a reintegro de gastos (desplazamiento, alojamiento, manutenci\u00f3n) de los sujetos del ensayo. En un 41,7% de los supuestos no se hace constar expresamente que a los investigadores se les va a retribuir por su trabajo. Si bien se suele hacer una referencia gen\u00e9rica a la ley org\u00e1nica de protecci\u00f3n de datos, se obvian cuestiones tales como la relativa a la informaci\u00f3n de la existencia de un fichero (en un 54,2%), la identidad del responsable del fichero (en un 70,8%), la necesidad de la inscripci\u00f3n del fichero en la agencia espa\u00f1ola de protecci\u00f3n de datos (en un 95,8%) o la transferencia internacional de datos (en un 50%). La contrataci\u00f3n de un seguro contin\u00faa siendo preferido en la totalidad de los casos a la de una garant\u00eda financiera. En un 75% de las ocasiones se utiliza el t\u00e9rmino "estudio" como sin\u00f3nimo de ensayo cl\u00ednico, suavizando las connotaciones sem\u00e1nticas; en un 20,8% de los ensayos el lenguaje empleado en la hoja de informaci\u00f3n utiliza con frecuencia tecnicismos inapropiados. En ocasiones se ha detectado un "exceso" de informaci\u00f3n, con estudios cl\u00ednicos de hasta dieciocho hojas destinadas al paciente. Nunca se obtiene respuesta a la informaci\u00f3n remitida al ministerio fiscal e incluso se llega a obviar su remisi\u00f3n en un 41,7% de las ocasiones. Solamente un 4,2% especifica el derecho del paciente a acceder a las pruebas realizadas y un 16,7% a los resultados del ensayo. No resulta admisible que un 62,5% de los ensayos no contengan claramente el compromiso de publicaci\u00f3n de los resultados. conclusiones: no existe un cumplimiento riguroso de algunos aspectos relacionados con el proceso de obtenci\u00f3n del consentimiento informado y de normativa de protecci\u00f3n de datos; no existe un control riguroso sobre los publicaci\u00f3n de los resultados de los ensayos cl\u00ednicos; debe aclararse la funci\u00f3n que debe desarrollar el ministerio fiscal en el curso de un ensayo cl\u00ednico con menores. objectives: to analyse the degree of compliance of the main ethical and legal requirements regarding the tested pediatric clinical trials in the region of murcia between 2006 and 2012. To do a critical reading between theory and practice and highlighting the problematic issues in its implementation and making proposals to improve the evaluation process of pediatric clinical trials. methodology: descriptive study which aim is to analyze specific factual variables related to methodological, legal and ethical aspects of the pediatric clinical trials. The acquisition of the information necessary for the development of the investigation has been obtained through the analysis of the protocols and the patient's information sheets of the pediatric clinical trials with the existing drugs in the ethical committee of clinical investigations of the area 1 (murcia-oeste) results: the number of pediatric clinical trials (pcts) with drugs conducted in the region of murcia is within the national and european average(10% of all clinical trials conducted). Pediatric oncohematology studies and neuropediatrics prevail.The prototype for clinical trials conducted in the region of murcia is phase ii-iii studies, double – blind, controlled, parallel, multicenter,with a length of time between one and three years, and sponsored by the pharmaceutical industry in 50% of cases,with a preponderance of studies compared to placebo above average (37,5%) with a potential indirect benefit for the researched population(83,3%). On 38,5% of trials studied it is unspecified , the right of the patient to consult and to reflect with those persons that he wishes.On 87,5 % of trials ,there is no revocation clause.The right to get expenses refunded is not fixed clearly((travel, accommodation, support).On 41,7 % it is not stated specifically that the investigator are going to be remunerated for their work. Although there is a generic reference to the organic law on personal data protection, there are obviated such questions as the knowledge of the existence of a file (in 54,2 %), the identity of the person in charge of the file (in 70,8 %), the need for the inscription of the file in the spanish data protection agency (in 95,8 %) or the international data transference (in 50 %). The hiring of an insurance keeps on being preferred in the totality of the cases to that of a financial guarantee. In 75 % of the occasions the term used is "study" as synonymous of clinical essay, smoothing the semantic connotations; in 20,8 % of the essays the language used in the information sheets is often inappropriate due to technicality. In ocations an information "excess" has been detected, with clinical studies of up to eighteen sheets destined for the patient. There is never an answer to the information sent to the public prosecutor and even goes as far as to obviate its reference in 41,7 % of the occasions. Only 4,2 % it specifies the right of the patient to gain access to the realized tests and 16,7 % to the results of the trial. It does not turn out to be admissible that 62,5 % of the trial does not contain clearly the commitment of publication of the results. conclusions: there is not a strict compliance of some aspects related to the process of obtaining informed consent and data protection regulations .There is not a rigurous control over the publication of the results of clinical trials .It must be clarified the role of the public prosecutor in the development of the clinical trial under age subjects.<\/p>\n

 <\/p>\n

Datos acad\u00e9micos de la tesis doctoral \u00abLa participaci\u00f3n de los menores de edad en los ensayos cl\u00ednicos de la regi\u00f3n de murcia: consideraciones \u00e9tico-legales<\/strong>\u00ab<\/h3>\n
    \n
  • T\u00edtulo de la tesis:<\/strong>\u00a0 La participaci\u00f3n de los menores de edad en los ensayos cl\u00ednicos de la regi\u00f3n de murcia: consideraciones \u00e9tico-legales <\/li>\n
  • Autor:<\/strong>\u00a0 Pablo Vigueras Paredes <\/li>\n
  • Universidad:<\/strong>\u00a0 Murcia<\/li>\n
  • Fecha de lectura de la tesis:<\/strong>\u00a0 17\/10\/2014<\/li>\n<\/ul>\n

     <\/p>\n

    Direcci\u00f3n y tribunal<\/h3>\n
      \n
    • Director de la tesis<\/strong>\n
        \n
      • Juan Antonio Fernandez Campos<\/li>\n<\/ul>\n<\/li>\n
      • Tribunal<\/strong>\n
          \n
        • Presidente del tribunal: aurelio Luna maldonado <\/li>\n
        • marina Gisbert grifo (vocal)<\/li>\n
        • Carlos Mar\u00eda Romeo casabona (vocal)<\/li>\n
        • federico De montalvo j\u00ed\u00a4\u00ed\u00a4skel\u00ed\u00a4inen (vocal)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

           <\/p>\n","protected":false},"excerpt":{"rendered":"

          Tesis doctoral de Pablo Vigueras Paredes Objetivos: analizar el nivel de cumplimiento de los principales requisitos \u00e9tico-legales en los ensayos […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[25185,1251,23361,8235,161],"tags":[3274,26231,229923,204778,11389,229922],"class_list":["post-116481","post","type-post","status-publish","format-standard","hentry","category-bioetica","category-derecho-civil","category-etica-de-la-ciencia","category-murcia","category-pediatria","tag-aurelio-luna-maldonado","tag-carlos-maria-romeo-casabona","tag-federico-de-montalvo-jiiskeliinen","tag-juan-antonio-fernandez-campos","tag-marina-gisbert-grifo","tag-pablo-vigueras-paredes"],"_links":{"self":[{"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/posts\/116481","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/comments?post=116481"}],"version-history":[{"count":0,"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/posts\/116481\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/media?parent=116481"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/categories?post=116481"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.deberes.net\/tesis\/wp-json\/wp\/v2\/tags?post=116481"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}