{"id":4643,"date":"2026-09-28T20:17:35","date_gmt":"2026-09-28T20:17:35","guid":{"rendered":"https:\/\/slipstream1dev.wpenginepowered.com\/?post_type=resource&#038;p=4643"},"modified":"2026-09-28T20:17:36","modified_gmt":"2026-09-28T20:17:36","slug":"un-nouveau-livre-blanc-propose-une-feuille-de-route-pratique-pour-lutilisation-des-donnees-du-monde-reel-dans-les-approbations-de-medicaments-par-la-fda-et-les-extensions-dindication","status":"publish","type":"resource","link":"https:\/\/www.slipstreamls.com\/fr\/resources\/un-nouveau-livre-blanc-propose-une-feuille-de-route-pratique-pour-lutilisation-des-donnees-du-monde-reel-dans-les-approbations-de-medicaments-par-la-fda-et-les-extensions-dindication\/","title":{"rendered":"Un nouveau livre blanc propose une feuille de route pratique pour l\u2019utilisation des donn\u00e9es du monde r\u00e9el dans les approbations de m\u00e9dicaments par la FDA et les extensions d\u2019indication"},"content":{"rendered":"<section id=\"hero-6ac872122dcc9\"\n         class=\"centered-hero d-flex align-items-center text-center centered-hero--no-cards\"\n         style=\"background-color:#0f2060;--hero-video-overlay:rgba(0,0,0,0.35)\">\n\n    \n    \n    \n    <div class=\"container py-5 hero-content\">\n        <div class=\"row justify-content-center\">\n            <div class=\"col-xl-12\">\n\n                \n                                            <p class=\"mb-3 kicker\" style=\"color:#ffffff\">\n                            annonce                        <\/p>\n                    \n                                            <h1 class=\"fw-bold display-3 mb-3 title\" style=\"color:#ffffff;max-width:750px;margin-left:auto;margin-right:auto\">\n                            Un nouveau livre blanc propose une feuille de route pratique pour l\u2019utilisation des donn\u00e9es du monde r\u00e9el dans les approbations de m\u00e9dicaments par la FDA et les extensions d\u2019indication                        <\/h1>\n                    \n                                            <p class=\"mb-5 mx-auto description\" style=\"margin-left:auto;margin-right:auto\">\n                            R\u00e9dig\u00e9 par trois leaders des sciences de la vie ayant une exp\u00e9rience directe de la r\u00e9glementation de la FDA, ce livre blanc s\u2019appuie sur une pr\u00e9sentation donn\u00e9e lors de la DIA 2026                        <\/p>\n                    \n                    \n                    \n                \n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n<section class=\"ss-resource-meta-bar ss-resource-meta-bar--align-left\" style=\"margin:0 0 30px 0;background-color:#ffffff\">\n    <div class=\"container\">\n        <div class=\"ss-resource-meta-bar__inner\" >\n            <div class=\"ss-resource-meta-bar__row\">\n\n                <!-- LEFT -->\n                <div class=\"ss-resource-meta-bar__left\">\n\n                    \n                <\/div>\n\n                <!-- RIGHT -->\n                <div class=\"ss-resource-meta-bar__right\">\n\n                                            <a class=\"ss-resource-meta-bar__share a2a_dd\"\n                           href=\"https:\/\/www.addtoany.com\/share\"\n                           data-a2a-url=\"https:\/\/www.slipstreamls.com\/fr\/resources\/un-nouveau-livre-blanc-propose-une-feuille-de-route-pratique-pour-lutilisation-des-donnees-du-monde-reel-dans-les-approbations-de-medicaments-par-la-fda-et-les-extensions-dindication\/\"\n                           data-a2a-title=\"Un nouveau livre blanc propose une feuille de route pratique pour l\u2019utilisation des donn\u00e9es du monde r\u00e9el dans les approbations de m\u00e9dicaments par la FDA et les extensions d\u2019indication\"\n                           aria-label=\"Share\">\n                            <svg viewBox=\"0 0 24 24\" width=\"16\" height=\"16\" aria-hidden=\"true\">\n                                <path d=\"M18 8a3 3 0 1 0-2.83-4H15a3 3 0 0 0 .17 1l-7.2 4.1A3 3 0 0 0 6 8a3 3 0 1 0 1.97 5.26l7.2 4.1A3 3 0 0 0 15 19a3 3 0 1 0 .83-2.06l-7.2-4.1A3 3 0 0 0 9 11c0-.36-.06-.7-.17-1.02l7.2-4.1A3 3 0 0 0 18 8Z\"\n                                      fill=\"currentColor\"\/>\n                            <\/svg>\n                        <\/a>\n                    \n                    \n                                            <span class=\"ss-pill ss-pill--solid\">\n                            4 MIN READ                        <\/span>\n                    \n                    \n                    \n                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:25%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:50%\">\n<p class=\"wp-block-paragraph\">Slipstream, partenaire de conseil technologique exclusivement d\u00e9di\u00e9 aux sciences de la vie, a annonc\u00e9 aujourd\u2019hui la publication d\u2019un nouveau livre blanc \u00e9valu\u00e9 par des pairs dans Clinical Pharmacology and Therapeutics, qui pr\u00e9sente des orientations pratiques \u00e0 l\u2019intention des entreprises pharmaceutiques et biotechnologiques souhaitant utiliser des donn\u00e9es du monde r\u00e9el pour \u00e9tayer l\u2019approbation d\u2019un m\u00e9dicament par la FDA ou une extension d\u2019indication.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Le livre blanc, <em>A Practical Guide to Implementing Real-World Evidence as Primary Basis for Approval and Label Expansion<\/em>, est co-r\u00e9dig\u00e9 par le Dr Tracy Mayne, SVP of Regulatory and Life Sciences Research chez Slipstream Life Sciences ; le Dr Alan Brookhart de l\u2019Universit\u00e9 Duke et de Headwater Science ; et le Dr Nancy Dreyer, pr\u00e9sidente de Dreyer Strategies. S\u2019appuyant sur des d\u00e9cennies d\u2019exp\u00e9rience cumul\u00e9e dans la pr\u00e9sentation de donn\u00e9es probantes du monde r\u00e9el \u00e0 la FDA, les auteurs proposent une approche pratique, fond\u00e9e sur l\u2019exp\u00e9rience, pour appliquer les lignes directrices RWD\/RWE de la FDA aux donn\u00e9es probantes du monde r\u00e9el en vue de l\u2019approbation des m\u00e9dicaments et de l\u2019extension d\u2019indication.<\/p>\n\n\n\n<section class=\"ss-quote-highlight\" style=\"\">\n    <div class=\"container\">\n        <div class=\"ss-quote-highlight__inner\" style=\"\">\n\n            <figure class=\"ss-quote\" style=\"max-width:900px;line-height:130%;\">\n\n                <!-- OPEN QUOTE -->\n                <span class=\"ss-quote__mark ss-quote__mark--open\" aria-hidden=\"true\">\n                      <svg width=\"64\" height=\"51\" viewBox=\"0 0 64 51\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                        <path d=\"M27.7478 50.7013L0 50.7013L0 29.1228C0 25.3371 0.446343 21.7137 1.33903 18.2525C2.28132 14.7372 3.84353 11.6275 6.02566 8.92343C8.2078 6.21936 11.0595 4.0561 14.5806 2.43366C18.1514 0.811222 22.5405 0 27.7478 0L27.7478 13.953C24.7722 13.953 22.2925 14.3316 20.3087 15.0887C18.325 15.7918 16.738 16.8193 15.5477 18.1713C14.407 19.4693 13.5887 21.0377 13.0928 22.8764C12.5969 24.7152 12.3489 26.7973 12.3489 29.1228L12.3489 30.2585L27.7478 30.2585L27.7478 50.7013ZM64 50.7013L36.2522 50.7013L36.2522 29.1228C36.2522 25.3371 36.6985 21.7137 37.5912 18.2525C38.5335 14.7372 40.0957 11.6275 42.2779 8.92343C44.46 6.21936 47.3116 4.05611 50.8328 2.43367C54.4036 0.811224 58.7926 0 64 0L64 13.953C61.0244 13.953 58.5447 14.3316 56.5609 15.0887C54.6267 15.7918 53.0645 16.8193 51.8743 18.1713C50.684 19.4693 49.8409 21.0377 49.345 22.8764C48.849 24.7152 48.6011 26.7973 48.6011 29.1228L48.6011 30.2585L64 30.2585L64 50.7013Z\"\n                              fill=\"currentColor\"\/>\n                    <\/svg>\n                <\/span>\n\n                <!-- QUOTE TEXT -->\n                <blockquote class=\"ss-quote__text\">\n                    La FDA a fourni des feuilles de route sur la mani\u00e8re dont les donn\u00e9es probantes du monde r\u00e9el peuvent \u00eatre utilis\u00e9es, mais il subsiste de nombreuses lacunes lorsqu\u2019il s\u2019agit de leur application pratique                <\/blockquote>\n\n                <!-- CLOSE QUOTE -->\n                <span class=\"ss-quote__mark ss-quote__mark--close\" aria-hidden=\"true\">\n                 \n                    <svg width=\"64\" height=\"51\" viewBox=\"0 0 64 51\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                        <path d=\"M36.2522 0.000116734L64 0.000118256L64 21.5786C64 25.3643 63.5537 28.9877 62.661 32.4489C61.7187 35.9642 60.1565 39.0739 57.9743 41.778C55.7922 44.4821 52.9405 46.6453 49.4194 48.2678C45.8486 49.8902 41.4595 50.7014 36.2522 50.7014L36.2522 36.7484C39.2278 36.7484 41.7075 36.3698 43.6913 35.6127C45.675 34.9097 47.262 33.8821 48.4523 32.5301C49.593 31.2321 50.4113 29.6638 50.9072 27.825C51.4031 25.9862 51.6511 23.9041 51.6511 21.5786L51.6511 20.4429L36.2522 20.4429L36.2522 0.000116734ZM0 0.000114746L27.7478 0.000116268L27.7478 21.5786C27.7478 25.3643 27.3015 28.9877 26.4088 32.4489C25.4665 35.9642 23.9043 39.0739 21.7221 41.778C19.54 44.4821 16.6884 46.6453 13.1672 48.2678C9.59642 49.8902 5.20736 50.7014 0 50.7014L0 36.7484C2.97563 36.7484 5.45533 36.3698 7.43909 35.6127C9.37325 34.9096 10.9355 33.8821 12.1257 32.5301C13.316 31.2321 14.1591 29.6638 14.655 27.825C15.151 25.9862 15.3989 23.9041 15.3989 21.5786L15.3989 20.4429L0 20.4429L0 0.000114746Z\"\n                              fill=\"currentColor\"\/>\n                    <\/svg>\n                <\/span>\n\n            <\/figure>\n\n        <\/div>\n    <\/div>\n<\/section>\n\n\n<p class=\"wp-block-paragraph\">\u00ab La FDA a fourni des feuilles de route sur la mani\u00e8re dont les donn\u00e9es probantes du monde r\u00e9el peuvent \u00eatre utilis\u00e9es, mais il subsiste de nombreuses lacunes lorsqu\u2019il s\u2019agit de leur application pratique \u00bb, a d\u00e9clar\u00e9 Tracy Mayne, SVP of Regulatory and Life Sciences Research chez Slipstream.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"> La publication constitue un compl\u00e9ment \u00e0 une session pr\u00e9sent\u00e9e par les auteurs au DIA 2026 Innovation Theater, o\u00f9 ils ont partag\u00e9 leurs premiers enseignements sur ce sujet. La pr\u00e9sentation compl\u00e8te du DIA est disponible sur le <a href=\"https:\/\/www.slipstreamls.com\/resources\/real-world-evidence-in-a-single-trial-world\/?utm_source=businesswire&amp;utm_medium=press_release&amp;utm_campaign=cpt_pr_campaign\">site web de Slipstream<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00ab\u00a0Les donn\u00e9es du monde r\u00e9el peuvent fournir des preuves cr\u00e9dibles lorsque des essais randomis\u00e9s sont irr\u00e9alisables ou contraires \u00e0 l\u2019\u00e9thique, mais seulement si l\u2019\u00e9tude est con\u00e7ue et document\u00e9e avec la m\u00eame rigueur que celle que nous attendons d\u2019un essai. Ce guide vise \u00e0 aider les promoteurs \u00e0 r\u00e9gler correctement ces d\u00e9tails d\u00e8s le d\u00e9part, lorsque les corrections de trajectoire sont encore peu co\u00fbteuses\u00a0\u00bb, a d\u00e9clar\u00e9 le Dr Brookhart.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00ab Cet article r\u00e9pond \u00e0 de nombreuses questions pratiques sur le fait de savoir si les donn\u00e9es du monde r\u00e9el, la conception de l\u2019\u00e9tude et son ex\u00e9cution sont suffisamment solides pour \u00eatre soumises dans un dossier de preuves r\u00e9glementaires, autant de le\u00e7ons apprises \u00e0 la dure \u00bb, a d\u00e9clar\u00e9 le Dr Dreyer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Le livre blanc est disponible en libre acc\u00e8s \u00e0 <a href=\"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70487\">https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.70487<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L\u2019utilisation par la FDA des donn\u00e9es du monde r\u00e9el pour \u00e9tayer les d\u00e9cisions r\u00e9glementaires \u00e9volue rapidement, et les lignes directrices RWD\/RWE qui pr\u00e9cisent comment ces donn\u00e9es doivent \u00eatre g\u00e9n\u00e9r\u00e9es, document\u00e9es et soumises sont complexes. Ce n\u2019est que par l\u2019exp\u00e9rience pratique que l\u2019on d\u00e9couvre les d\u00e9fis et les obstacles \u00e0 la conformit\u00e9 aux exigences de la FDA, ainsi que la mani\u00e8re d\u2019y r\u00e9pondre.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pour les promoteurs, ce livre blanc offre un moyen pratique de r\u00e9duire les risques et les approximations li\u00e9s \u00e0 la soumission d\u2019un dossier de donn\u00e9es probantes du monde r\u00e9el \u00e0 la FDA, que l\u2019objectif soit une approbation initiale ou une extension d\u2019indication. Si la majorit\u00e9 des cas d\u2019usage concernent l\u2019oncologie et les maladies rares, toute indication pour laquelle un essai randomis\u00e9 contr\u00f4l\u00e9 par placebo est irr\u00e9alisable ou contraire \u00e0 l\u2019\u00e9thique offre l\u2019occasion d\u2019int\u00e9grer des donn\u00e9es du monde r\u00e9el dans le dossier de preuves.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les trois auteurs ont \u00e9t\u00e9 directement impliqu\u00e9s dans de multiples soumissions \u00e0 la FDA utilisant des donn\u00e9es probantes du monde r\u00e9el, contribuant \u00e0 \u00e9tablir les standards dans cet environnement en \u00e9volution rapide, ce qui renforce leur leadership dans ce domaine.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00c0 propos de Slipstream : <\/strong>Slipstream est un partenaire de conseil technologique exclusivement d\u00e9di\u00e9 aux sciences de la vie. Ses \u00e9quipes agissent comme le prolongement de celles de leurs clients, apportant une expertise approfondie du domaine dans la R&amp;D, les plateformes d\u2019entreprise, les donn\u00e9es et les op\u00e9rations afin d\u2019aider les organisations \u00e0 acc\u00e9l\u00e9rer la recherche, optimiser les op\u00e9rations et am\u00e9liorer les r\u00e9sultats pour les patients. Pour en savoir plus sur Slipstream Life Sciences, rendez-vous sur slipstreamls.com.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Contact presse : <\/strong>Isabella Canuso, Content Marketing, Slipstream, isabella.canuso@slipstreamls.com<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\"><\/p>\n<\/blockquote>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:25%\"><\/div>\n<\/div>\n\n\n    <section class=\"cta-section d-flex align-items-center text-center\"\n             id=\"cta-6ac872123a469\"\n            style=\"background-color:#072267\">\n\n        \n        \n        <!-- LAYER 2: content -->\n        <div class=\"container cta-content\">\n            <div class=\"row justify-content-center\">\n                <div class=\"col-12\">\n\n                    \n                                            <h2 class=\"title mb-4\" style=\"\">\n                            Acc\u00e9l\u00e9rez la suite.                        <\/h2>\n                    \n                                            <p class=\"lead description mb-4\" style=\"max-width:100%;margin-left:auto;margin-right:auto\">\n                            Prenez contact avec notre \u00e9quipe pour concevoir des plateformes d\u2019entreprise, des fondations de donn\u00e9es modernes et des op\u00e9rations \u00e9volutives qui acc\u00e9l\u00e8rent l\u2019impact.                        <\/p>\n                    \n                                                                        <button type=\"button\"\n                                    class=\"cta-btn button\"\n                                    style=\"\"\n                                    data-bs-toggle=\"modal\"\n                                    data-bs-target=\"#cta-6ac872123a469-modal\">\n                  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