{"id":4729,"date":"2018-01-22T10:00:44","date_gmt":"2018-01-22T09:00:44","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=4729"},"modified":"2025-05-21T10:40:13","modified_gmt":"2025-05-21T08:40:13","slug":"comite-de-surveillance-de-suivi-de-donnees-dsmb","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/comite-de-surveillance-de-suivi-de-donnees-dsmb\/","title":{"rendered":"Comit\u00e9 de surveillance et de suivi de donn\u00e9es (DSMB)"},"content":{"rendered":"<p><a href=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/wp-content\/uploads\/2018\/01\/photo-1500015139098-84b51c349a60.jpeg?ssl=1\"><img data-recalc-dims=\"1\" decoding=\"async\" class=\"alignnone size-full wp-image-4731 lazyload\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/wp-content\/uploads\/2018\/01\/photo-1500015139098-84b51c349a60.jpeg?resize=750%2C501&#038;ssl=1\" alt=\"\" width=\"750\" height=\"501\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 750px; --smush-placeholder-aspect-ratio: 750\/501;\" \/><\/a><\/p>\n<p><em>Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique<\/em><\/p>\n<p style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\"><span style=\"font-size: 11.5pt;\">Data Safety Monitoring Board (DSMB) ou Data Monitoring Committee (DMC), c\u2019est un comit\u00e9 de surveillance ind\u00e9pendant, d\u00e9sign\u00e9 par le promoteur.<\/span><\/p>\n<p><!--more--><\/p>\n<h2 style=\"text-align: justify;\"><strong><span style=\"font-size: 11.0pt; font-family: Calibri;\"><span style=\"color: #0000ff;\">Quand faut-il cr\u00e9er un DSMB\u00a0?<\/span> <\/span><\/strong><\/h2>\n<p style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\">Lorsque la recherche constitue un risque non n\u00e9gligeable (du fait des proc\u00e9dures et\/ou des traitements de l\u2019essai) pour les patients se pr\u00eatant \u00e0 la recherche, et\/ou lorsque des analyses statistiques sont r\u00e9p\u00e9t\u00e9es en cours d\u2019essai et pourraient permettre d\u2019arr\u00eater pr\u00e9matur\u00e9ment l\u2019essai, soit parce que l\u2019efficacit\u00e9 d\u2019un bras de traitement est d\u00e9montr\u00e9e, soit parce que aucune diff\u00e9rence n\u2019est d\u00e9celable et rend alors inutile de poursuivre l\u2019essai (notion de futilit\u00e9).<\/p>\n<h2 style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\"><span style=\"color: #0000ff;\"><strong><span style=\"font-size: 11.0pt; font-family: Calibri;\">R\u00f4le<\/span><\/strong><\/span><\/h2>\n<p style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\">Son r\u00f4le est avant tout d\u2019analyser attentivement les effets ind\u00e9sirables graves survenant durant l\u2019essai, d\u2019\u00e9valuer le rapport b\u00e9n\u00e9fice\/risque et d\u2019aider le promoteur \u00e0 am\u00e9liorer la s\u00e9curit\u00e9 des patients, voire \u00e0 arr\u00eater pr\u00e9matur\u00e9ment l\u2019\u00e9tude.<\/p>\n<p style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\">Il \u00e9value l\u2019efficacit\u00e9 car dans le cas d\u2019absence d\u2019efficacit\u00e9, l\u2019essai peut \u00eatre arr\u00eat\u00e9 pour futilit\u00e9<\/p>\n<p style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\">Il \u00e9met aussi des recommandations quant \u00e0 la fiabilit\u00e9 des donn\u00e9es (dans le cas o\u00f9 des d\u00e9viations importantes ont \u00e9t\u00e9 constat\u00e9es)<\/p>\n<p style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\">Le promoteur est responsable de se conformer aux recommandations.<\/p>\n<p style=\"margin-bottom: 0.0001pt; line-height: normal; text-align: justify;\">R\u00e9f\u00e9rence\u00a0: <a href=\"http:\/\/www.recherchecliniquepariscentre.fr\">www.recherchecliniquepariscentre.fr<\/a><\/p>\n<hr \/>\n<p style=\"text-align: center;\"><strong>Vous avez besoin d&rsquo;une prestation en recherche clinique ? contactez PHARMASPECIFIC en vous rendant sur notre site en cliquant ici : <a href=\"https:\/\/pharmaspecific.com\/devis\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/pharmaspecific.com\/devis\/<\/a><\/strong><\/p>\n<p style=\"text-align: center;\"><em>Si tu as des questions sur le m\u00e9tier d\u2019attach\u00e9 de recherche clinique ou sur une carri\u00e8re dans la recherche clinique, tu peux la mettre dans les commentaires ci-dessous. Nous te r\u00e9pondrons dans les plus brefs d\u00e9lais.\u00a0<\/em><\/p>\n<p style=\"text-align: center;\"><em>Si tu veux \u00eatre coach\u00e9, si tu veux une r\u00e9ponse personnalis\u00e9e \u00e0 tes questions ou \u00eatre en contact avec d\u2019autres professionnels de la recherche clinique, tu peux te rendre sur\u00a0<a href=\"https:\/\/pharmaspecific-training.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/pharmaspecific-training.com\/<\/a><\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Article r\u00e9dig\u00e9 par la Soci\u00e9t\u00e9 Pharmaspecific, sp\u00e9cialiste en recherche clinique Data Safety Monitoring Board (DSMB) ou Data Monitoring&#8230;<\/p>","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[450],"tags":[66,91,325],"class_list":{"0":"post-4729","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-actualites-de-la-recherche-clinique","7":"tag-attache-de-recherche-clinique","8":"tag-comite-de-surveillance","9":"tag-dsmb"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":false},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"<!-- 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