{"id":7745,"date":"2020-06-05T11:44:07","date_gmt":"2020-06-05T11:44:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7745"},"modified":"2020-06-05T11:55:08","modified_gmt":"2020-06-05T11:55:08","slug":"the-difficulties-in-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fr\/the-difficulties-in-clinical-trials\/","title":{"rendered":"Les difficult\u00e9s des essais cliniques"},"content":{"rendered":"

Les \u00e9tudes scientifiques sont con\u00e7ues avec un certain nombre d'exp\u00e9riences de contr\u00f4le et de r\u00e9plications de sorte que la r\u00e9ponse \u00e0 la question \u00e9tudi\u00e9e soit claire. Dans les montages exp\u00e9rimentaux complexes comme les essais cliniques, les r\u00e9sultats sont souvent moins clairs, ce qui rend l'extrapolation des donn\u00e9es impossible [1]. En fait, des rapports ont indiqu\u00e9 que de nombreux essais cliniques sont insuffisamment con\u00e7us et donnent des r\u00e9sultats ambigus ou inutiles [1-3]. D'autres probl\u00e8mes tels que le recrutement d'un nombre suffisant de patients pour obtenir une taille d'\u00e9chantillon correcte [4], les pr\u00e9jug\u00e9s et les perceptions au cours du recrutement [2, 5], le retrait d'un patient d'un essai [5, 6], la non-transparence ou l'absence d'un examen suffisant par des experts [1, 7] sont des facteurs tr\u00e8s r\u00e9els qui peuvent brouiller l'\u00e9tude et rendre difficile l'obtention de conclusions claires. En outre, la validation des m\u00e9dicaments se poursuit g\u00e9n\u00e9ralement apr\u00e8s l'autorisation de mise sur le march\u00e9, au niveau de la population, o\u00f9 les effets rares, ind\u00e9sirables ou hors cible ne sont observ\u00e9s qu'avec un \u00e9chantillon de grande taille et sur des p\u00e9riodes plus longues [8].\u00a0<\/span><\/p>\n

L'ensemble du processus de d\u00e9veloppement d'un m\u00e9dicament est long et ardu car il implique des tests rigoureux d'efficacit\u00e9 et de s\u00e9curit\u00e9 chez l'homme. Cependant, ce processus est n\u00e9cessaire afin de fournir au public un profil raisonnablement complet du nouveau m\u00e9dicament ou d'un m\u00e9dicament existant utilis\u00e9 pour une nouvelle indication. La rigueur des essais cliniques est \u00e9galement n\u00e9cessaire afin de minimiser les trag\u00e9dies telles que celles du <\/span>proc\u00e8s BIA 10-2474 [9, 10], la <\/span>Essai sur le theralizumab [11], <\/span>l'essai de th\u00e9rapie g\u00e9nique pour le d\u00e9ficit en ornithine transcarbamylase (OTC) [12], <\/span>et la catastrophe de la thalidomide dans les ann\u00e9es 1950 et 1960 [13].\u00a0<\/span><\/p>\n

Chaque trag\u00e9die a donn\u00e9 lieu \u00e0 de nombreux efforts de la part de la communaut\u00e9 scientifique, des institutions m\u00e9dicales et des organismes gouvernementaux pour accro\u00eetre la communication, la consultation et la reconnaissance pr\u00e9coce des probl\u00e8mes afin de pr\u00e9venir les dommages et de mieux \u00e9valuer l'applicabilit\u00e9 des futurs essais [14-17]. Cependant, le processus qui va de la d\u00e9couverte des m\u00e9dicaments \u00e0 leur commercialisation est encore loin d'\u00eatre parfait. Au cours des derniers mois, le monde a \u00e9t\u00e9 t\u00e9moin de la complexit\u00e9 et, souvent, de l'absence de conclusions des \u00e9tudes scientifiques. Avec les r\u00e9centes nouvelles des r\u00e9sultats positifs de l'essai Remdesivir chez les patients atteints de COVID-19 s\u00e9v\u00e8re et l'approbation acc\u00e9l\u00e9r\u00e9e du m\u00e9dicament par la FDA [18, 19], nous devons nous rappeler qu'il reste encore du travail \u00e0 faire.\u00a0<\/span><\/p>\n

    \n
  1. Ioannidis, J.P., <\/span>Why Most Clinical Recherche<\/a> Is Not Useful.<\/span><\/i> PLoS Med, 2016. 13(6) : p. e1002049.<\/span><\/li>\n
  2. Treweek, S. et M. Zwarenstein, <\/span>Making trials matter : pragmatic and explanatory trials and the problem of applicability.<\/span><\/i> Essais, 2009. 10 : p. 37.<\/span><\/li>\n
  3. Slattery, P., A.K. Saeri, et P. Bragge, <\/span>La co-conception de la recherche dans le domaine de la sant\u00e9 : un aper\u00e7u rapide des examens.<\/span><\/i> Health Res Policy Syst, 2020. 18(1) : p. 17.<\/span><\/li>\n
  4. Reynolds, T., <\/span>Essais cliniques : la technologie peut-elle r\u00e9soudre le probl\u00e8me du faible recrutement ?<\/span><\/i> BMJ, 2011. 342 : p. d3662.<\/span><\/li>\n
  5. Lehmann, B.A., et al, <\/span>\"And Then He Got into the Wrong Group\" : Une \u00e9tude qualitative explorant les effets de la randomisation dans le recrutement d'un essai contr\u00f4l\u00e9 randomis\u00e9.<\/span><\/i> Int J Environ Res Public Health, 2020. 17(6).<\/span><\/li>\n
  6. Cleland , J.G.F., et al, <\/span>Une m\u00e9thode pour r\u00e9duire la perte de suivi dans les essais cliniques : le retrait du consentement \u00e9clair\u00e9.<\/span><\/i> European Journal of Heart Failure 2004. 6<\/span><\/li>\n<\/ol>\n

    \u00a0<\/b>(1).<\/span><\/p>\n

      \n
    1. Miyakawa, T., <\/span>Pas de donn\u00e9es brutes, pas de science : une autre source possible de la crise de la reproductibilit\u00e9.<\/span><\/i> Mol Brain, 2020. <\/span>13<\/b>(1) : p. 24.<\/span><\/li>\n
    2. Raj, N., et al, <\/span>Surveillance post-march\u00e9 : une revue des aspects cl\u00e9s et des mesures sur le fonctionnement efficace dans le contexte du Royaume-Uni et du Canada.<\/span><\/i> Ther Adv Drug Saf, 2019. <\/span>10<\/b>: p. 2042098619865413.<\/span><\/li>\n
    3. Randerson, J., <\/span>Un essai clinique fran\u00e7ais fatal n'a pas v\u00e9rifi\u00e9 les donn\u00e9es avant d'augmenter la dose du m\u00e9dicament.<\/span><\/i> Nature News, 2016.<\/span><\/li>\n
    4. Kaur, R., P. Sidhu, et S. Singh, <\/span>Quel a \u00e9t\u00e9 l'\u00e9chec de l'essai clinique de phase I du BIA 10-2474 ? Sp\u00e9culations globales et recommandations pour les futurs essais de phase I.<\/span><\/i> J Pharmacol Pharmacother, 2016. <\/span>7<\/b>(3) : p. 120-6.<\/span><\/li>\n
    5. Attarwala, H., <\/span>TGN1412 : De la d\u00e9couverte au d\u00e9sastre.<\/span><\/i> J Young Pharm, 2010. <\/span>2<\/b>(3) : p. 332-6.<\/span><\/li>\n
    6. Rinde, M., <\/span>La mort de Jesse Gelsinger, 20 ans apr\u00e8s<\/span><\/i>en <\/span>Science History Institute - Distillations<\/span><\/i>. 2019.<\/span><\/li>\n
    7. Vargesson, N., <\/span>T\u00e9ratogen\u00e8se induite par la thalidomide : histoire et m\u00e9canismes.<\/span><\/i> Birth Defects Res C Embryo Today, 2015. <\/span>105<\/b>(2) : p. 140-56.<\/span><\/li>\n
    8. Lipman, P.D., L. Dluzak, et C.M. Stoney, <\/span>Cette \u00e9tude est-elle r\u00e9alisable ? Faciliter la gestion des \u00e9tapes de planification des essais pragmatiques dans le cadre d'un m\u00e9canisme de financement par \u00e9tapes.<\/span><\/i> Essais, 2019. <\/span>20<\/b>(1) : p. 307.<\/span><\/li>\n
    9. Dal-R\u00e9, R., P. Janiaud, et J.P.A. Ioannidis, <\/span>Les preuves du monde r\u00e9el : Quel est le degr\u00e9 de pragmatisme des essais contr\u00f4l\u00e9s randomis\u00e9s qualifi\u00e9s de pragmatiques ?<\/span><\/i> BMC Med, 2018. <\/span>16<\/b>(1) : p. 49.<\/span><\/li>\n
    10. Reijers, J.A.A., et al, <\/span>Immunostimulation d\u00e9favorable caus\u00e9e par des impuret\u00e9s : Le c\u00f4t\u00e9 obscur des produits biopharmaceutiques.<\/span><\/i> Br J Clin Pharmacol, 2019. <\/span>85<\/b>(7) : p. 1418-1426.<\/span><\/li>\n
    11. Van Norman, G.A., <\/span>Limites des \u00e9tudes sur les animaux pour pr\u00e9dire la toxicit\u00e9 dans les essais cliniques : Est-il temps de repenser notre approche actuelle ?<\/span><\/i> JACC Basic Transl Sci, 2019. <\/span>4<\/b>(7) : p. 845-854.<\/span><\/li>\n
    12. Maladies, N.I.o.A.a.I., <\/span>Un essai clinique du NIH montre que le Remdesivir acc\u00e9l\u00e8re la gu\u00e9rison du COVID-19 avanc\u00e9.<\/span><\/i>, N.I.o. Health, \u00e9diteur. 2020.<\/span><\/li>\n
    13. Gilead, <\/span>Gilead annonce les r\u00e9sultats de l'essai de phase 3 de l'antiviral exp\u00e9rimental Remdesivir chez les patients atteints de COVID-19 s\u00e9v\u00e8re<\/span><\/i>Gilead, \u00e9diteur. 2020.<\/span><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"

      Les \u00e9tudes scientifiques sont con\u00e7ues avec un certain nombre d'exp\u00e9riences de contr\u00f4le et de r\u00e9plications de sorte que la r\u00e9ponse \u00e0 la question \u00e9tudi\u00e9e soit claire. Dans les montages exp\u00e9rimentaux complexes comme les essais cliniques, les r\u00e9sultats sont souvent moins clairs, ce qui rend l'extrapolation des donn\u00e9es impossible [1]. En fait, des rapports ont indiqu\u00e9 que de nombreux essais cliniques sont insuffisamment con\u00e7us, ce qui donne des r\u00e9sultats ambigus.<\/p>\n

      Lire la suite<\/a><\/div>","protected":false},"author":12,"featured_media":7750,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[435],"tags":[],"acf":[],"yoast_head":"\nThe Difficulties in Clinical Trials - The Kolabtree Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/the-difficulties-in-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Difficulties in Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"Scientific studies are designed with a number of control experiments and replications such that the answer to the question being investigated is clear. 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