{"id":8151,"date":"2020-07-30T09:21:34","date_gmt":"2020-07-30T09:21:34","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8151"},"modified":"2020-07-30T09:30:15","modified_gmt":"2020-07-30T09:30:15","slug":"the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fr\/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/","title":{"rendered":"L'impact de COVID-19 sur les essais cliniques : d\u00e9fis et opportunit\u00e9s"},"content":{"rendered":"

Dans cet article\u00a0r\u00e9dacteur m\u00e9dical ind\u00e9pendant<\/a>\u00a0pour Kolabtree\u00a0Laura Moro-Martin<\/a>MSc, PhD, discute de l'impact de COVID-19 sur les essais cliniques.\u00a0<\/i><\/b><\/span><\/p>\n

La pand\u00e9mie de coronavirus 2019 (COVID-19) a sans aucun doute un effet perturbateur sur les syst\u00e8mes de sant\u00e9 et la prestation des soins dans le monde entier. L'effondrement des syst\u00e8mes de sant\u00e9 dans de nombreux pays devrait entra\u00eener une augmentation pr\u00e9occupante de la mortalit\u00e9 directe due au COVID-19 et de la mortalit\u00e9 indirecte due \u00e0 d'autres pathologies [1,2]. Par exemple, les visites aux urgences ont \u00e9t\u00e9 consid\u00e9rablement r\u00e9duites [3] et plusieurs campagnes de vaccination ont \u00e9t\u00e9 interrompues en raison de l'\u00e9mergence du COVID-19 [4], ce qui peut contribuer \u00e0 la morbidit\u00e9 et \u00e0 la mortalit\u00e9 indirectes.<\/p>\n

Pratique de la recherche clinique<\/a> ne fait pas exception \u00e0 la r\u00e8gle, la pand\u00e9mie ayant entra\u00een\u00e9 d'\u00e9normes perturbations dans les essais cliniques en cours. Cela est particuli\u00e8rement vrai pour les essais qui ne concernent pas directement la pr\u00e9vention ou le traitement du COVID-19, et ceux qui n\u00e9cessitent l'acc\u00e8s des participants aux sites cliniques. Une \u00e9tude espagnole sur les essais de phase pr\u00e9coce pour le cancer p\u00e9diatrique a fait \u00e9tat de p\u00e9nuries de personnel, de difficult\u00e9s \u00e0 recruter des patients (jusqu'\u00e0 75% de r\u00e9duction de l'inscription pr\u00e9vue et 50% d'interruption du recrutement dans les essais en cours), de probl\u00e8mes pour la continuit\u00e9 du traitement et de retards dans les \u00e9valuations des essais (avec des activit\u00e9s de surveillance report\u00e9es dans 73% des cas) [5]. Une enqu\u00eate de l'American Society of Clinical Oncology sur 32 programmes d'essais cliniques sur le cancer a identifi\u00e9 de nombreux d\u00e9fis, notamment des difficult\u00e9s de recrutement (60% des r\u00e9pondants ont d\u00e9clar\u00e9 avoir interrompu le recrutement et\/ou le d\u00e9pistage) et de respect du protocole, une diminution des visites des patients (60% des r\u00e9pondants), des limitations de personnel et une disponibilit\u00e9 r\u00e9duite des services auxiliaires (50% des r\u00e9pondants) [6]. Pour les patients atteints de cancer ou d'autres maladies graves, la participation \u00e0 un essai clinique peut constituer une partie essentielle du traitement qui ne peut \u00eatre interrompue.\u00a0<\/span><\/p>\n

Parmi les autres d\u00e9fis signal\u00e9s comme cons\u00e9quence de la pand\u00e9mie, citons les interactions avec les promoteurs et les ORC concernant la modification des proc\u00e9dures d'essai, ainsi que les modifications et\/ou d\u00e9viations de protocole - intentionnelles ou non - dont on ignore les effets sur l'int\u00e9grit\u00e9 scientifique, l'interpr\u00e9tation et les conclusions des essais [6]. Certains auteurs ont mis en garde contre la possibilit\u00e9 que les changements forc\u00e9s introduits dans les essais cliniques par la pand\u00e9mie - tels que la diminution des visites de suivi, la d\u00e9t\u00e9rioration de la sant\u00e9 mentale ou physique des participants, ou m\u00eame l'infection par le nouveau coronavirus - puissent interf\u00e9rer avec les r\u00e9sultats des risques et des avantages du traitement [7]. En outre, l'impact du COVID-19 sur les essais cliniques est in\u00e9gal selon le domaine th\u00e9rapeutique. Un rapport a constat\u00e9 une baisse du nombre de participants allant de 34% pour les maladies respiratoires \u00e0 80% pour les maladies endocriniennes, avec des pourcentages interm\u00e9diaires pour les autres domaines th\u00e9rapeutiques (47% pour les maladies infectieuses, 48% pour l'oncologie, 64% pour la dermatologie, 68% pour les maladies neurologiques et 70% pour les maladies cardiovasculaires) [8].<\/span><\/p>\n

La Food and Drug Administration (FDA) des \u00c9tats-Unis [9] a publi\u00e9 des conseils \u00e0 l'intention de l'industrie, des enqu\u00eateurs et des comit\u00e9s d'examen institutionnels pour mener des essais cliniques de produits m\u00e9dicaux pendant la crise du COVID-19 tout en assurant la protection des patients et des travailleurs de la sant\u00e9. De m\u00eame, l'Agence europ\u00e9enne des m\u00e9dicaments (EMA) a publi\u00e9 des conseils \u00e0 l'intention des promoteurs sur la mani\u00e8re de g\u00e9rer les essais cliniques pendant la pand\u00e9mie [10]. Ces conseils soutiennent une certaine flexibilit\u00e9 du protocole en ce qui concerne la politique et les proc\u00e9dures visant \u00e0 garantir l'int\u00e9grit\u00e9 de la recherche clinique, y compris les changements dans les visites et les proc\u00e9dures de l'\u00e9tude, la collecte de donn\u00e9es, le suivi de l'\u00e9tude, le signalement des \u00e9v\u00e9nements ind\u00e9sirables, ou les changements d'investigateurs, de personnel du site et\/ou de moniteurs en raison de la maladie COVID-19, des restrictions de voyage ou des mesures de quarantaine [11]. Les agences m\u00e9dicales de diff\u00e9rents pays ont adopt\u00e9 une vari\u00e9t\u00e9 de mesures pour assurer la s\u00e9curit\u00e9 et le bien-\u00eatre des sujets d'essai pendant la pand\u00e9mie, et un guide pour aider les promoteurs \u00e0 g\u00e9rer les essais cliniques r\u00e9sumant plusieurs mesures nationales a \u00e9t\u00e9 publi\u00e9 [12].\u00a0<\/span><\/p>\n

Once the main obstacles have been identified \u2212mostly mobility and travel restrictions, lack of adequate technologies and disruptions in supply chains [8]\u2212 COVID-19 may be seen as an opportunity to ‘rethink’ clinical trials. Some of the solutions proposed to overcome these challenges [13,14] include moving clinical sites to countries and regions less impacted by COVID-19, virtualization of several aspects of the trial (such as remote consent, remote randomization, and remote data capture and reporting), use of technology to closely monitor patient volume and drug supply to minimize disruptions, creation of synthetic control arms from historical trial data combined with intelligence artificielle<\/a> algorithms, or offering in-home clinical services. In particular, technology innovation can provide new tools to guarantee the continuity and success of clinical studies during the pandemics. An example of this innovation is a risk-based predictive analytical approach powered by machine learning that can offer predictions and forecasts to support decision-making during clinical operations management [15].<\/span><\/p>\n

Il est clair que l'effet disruptif de COVID-19 a boulevers\u00e9 la mani\u00e8re de mener les essais cliniques, poussant \u00e0 la num\u00e9risation des soins de sant\u00e9 et \u00e0 l'utilisation d'outils et de m\u00e9thodologies innovants. Profitons de cette perturbation pour am\u00e9liorer l'exp\u00e9rience des patients et mettre sur le march\u00e9 des th\u00e9rapies s\u00fbres, efficaces et accessibles.<\/span><\/p>\n

Bibliographie<\/b><\/p>\n

    \n
  1. Roberton T, Carter ED, Chou VB, Stegmuller AR, Jackson BD, et al. (2020) Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries : a modelling study. Lancet Glob Heal. doi:10.1016\/S2214-109X(20)30229-1.<\/span><\/li>\n
  2. Hogan AB, Jewell B, Sherrard-Smith E, Vesga J, Watson OJ, et al. (2020) Report 19 : The Potential Impact of the COVID-19 Epidemic on HIV, TB and Malaria in Low-and Middle-Income Countries. Imperial College of London.<\/span><\/li>\n
  3. Lazzerini M, Barbi E, Apicella A, Marchetti F, Cardinale F, et al. (2020) Delayed access or provision of care in Italy resulting from fear of COVID-19. Lancet Child Adolesc Heal 4 : e10-e11. doi:10.1016\/S2352-4642(20)30108-5.<\/span><\/li>\n
  4. Organisation mondiale de la sant\u00e9 (2020) Au moins 80 millions d'enfants de moins d'un an risquent de contracter des maladies telles que la dipht\u00e9rie, la rougeole et la polio car le COVID-19 perturbe les efforts de vaccination de routine, pr\u00e9viennent Gavi, l'OMS et l'UNICEF. Disponible sur ici<\/a>. Consult\u00e9 le 5 juin 2020.<\/span><\/li>\n
  5. Rubio-San-Simon A, Verd\u00fa-Amor\u00f3s J, Hladun R, Ribelles AJ, Molero M, Guerra-Garc\u00eda P, P\u00e9rez-Mart\u00ednez A, Casta\u00f1eda A, Ca\u00f1ete A, Rojas Td, Moreno L BF (2020) Challenges in Early Phase Clinical Trials for Childhood Cancer During the COVID-19 Pandemic : Un rapport du groupe des nouveaux agents de la Soci\u00e9t\u00e9 espagnole d'h\u00e9matologie et d'oncologie p\u00e9diatrique (SEHOP). Clin Transl Oncol : 1\u20137. doi:10.1007\/S12094-020-02399-3.<\/span><\/li>\n
  6. Waterhouse DM, Harvey RD, Hurley P, Levit LA, Kim ES, et al. (2020) Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation : Findings From an American Society of Clinical Oncology Survey. https:\/\/doi.org\/101200\/OP2000275. doi:10.1200\/OP.20.00275.<\/span><\/li>\n
  7. Servick K (2020) Les essais cliniques se poursuivent pour des maladies autres que le COVID-19. Les effets de la pand\u00e9mie se glissent-ils dans leurs donn\u00e9es ? Science. Disponible sur ici<\/a>. Consult\u00e9 le 5 juin 2020.<\/span><\/li>\n
  8. Medidata (2020) COVID-19 et les essais cliniques : La perspective de Medidata. Version 5.0. Disponible sur ici<\/a>. Consult\u00e9 le 5 juin 2020.<\/span><\/li>\n
  9. US Food and Drug Administration (2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards. Disponible sur ici<\/a>. Consult\u00e9 le 5 juin 2020.<\/span><\/li>\n
  10. Agence europ\u00e9enne des m\u00e9dicaments (2020) Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic. Disponible sur ici<\/a>. Consult\u00e9 le 2 juin 2020.<\/span><\/li>\n
  11. Sarah Morgan, Liz O'Neil, Karin Parks (2020) Impact of COVID-19 on Clinical Trials. Disponible sur ici<\/a>. Consult\u00e9 le 2 juin 2020.<\/span><\/li>\n
  12. DLA Piper (2020) A guide to managing clinical trials during the COVID-19 pandemic. Disponible sur ici<\/a>. Consult\u00e9 le 5 juin 2020.<\/span><\/li>\n
  13. Fareed Melhem (2020) The Global Impact of COVID-19 on Clinical Trials and the Way Forward | Technology Networks. Disponible sur ici<\/a>. Consult\u00e9 le 5 juin 2020.<\/span><\/li>\n
  14. ICON plc (2020) Minimiser l'impact de COVID-19 sur les essais cliniques avec des services cliniques \u00e0 domicile. Disponible sur ici<\/a>. Consult\u00e9 le 5 juin 2020.<\/span><\/li>\n
  15. Ben van der Schaaf, Thomas Unger, Michael Eiden, Ben Enejo, Craig Wylie, Tom Teixeira RE (2020) Managing clinical trials during COVID-19 and beyond. Disponible sur ici<\/a>. Consult\u00e9 le 2 juin 2020.<\/span><\/li>\n<\/ol>\n

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

    Dans cet article, la r\u00e9dactrice m\u00e9dicale ind\u00e9pendante de Kolabtree Laura Moro-Martin, MSc, PhD, aborde l'impact du COVID-19 sur les essais cliniques. La pand\u00e9mie de coronavirus 2019 (COVID-19) a sans aucun doute un effet perturbateur sur les syst\u00e8mes de sant\u00e9 et la prestation de soins dans le monde entier. On pr\u00e9voit que l'effondrement des syst\u00e8mes de sant\u00e9 dans de nombreux pays entra\u00eenera une augmentation inqui\u00e9tante de la mortalit\u00e9 directe due \u00e0 la maladie.<\/p>\n

    Lire la suite<\/a><\/div>","protected":false},"author":12,"featured_media":8155,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,435],"tags":[],"acf":[],"yoast_head":"\nThe impact of COVID-19 on clinical trials: challenges and opportunities<\/title>\n<meta name=\"description\" content=\"COVID-19 has shifted the way we conduct clinical trials, pushing towards the digitalization of healthcare and the use of innovative tools and methodologies.\" \/>\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-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The impact of COVID-19 on clinical trials: challenges and 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