Academic Journal

Paediatric Inflammatory Bowel Disease:A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents

التفاصيل البيبلوغرافية
العنوان: Paediatric Inflammatory Bowel Disease:A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents
المؤلفون: Croft, Nicholas M., de Ridder, Lissy, Griffiths, Anne M., Hyams, Jeffrey S., Ruemmele, Frank M., Turner, Dan, Cheng, Katharine, Lutsar, Irja, Greco, Marco, Gołębiewska, Zuzanna, Laumond, Floriane, Cavaller-Bellaubi, Maria, Elgreey, Adam, Altepeter, Tara A., Pallidis, Chrissi, Norga, Koen, Nelson, Robert, Crandall, Wallace, Vassal, Gilles
المصدر: Croft , N M , de Ridder , L , Griffiths , A M , Hyams , J S , Ruemmele , F M , Turner , D , Cheng , K , Lutsar , I , Greco , M , Gołębiewska , Z , Laumond , F , Cavaller-Bellaubi , M , Elgreey , A , Altepeter , T A , Pallidis , C , Norga , K , Nelson , R , Crandall , W & Vassal , G 2023 , ' Paediatric Inflammatory Bowel Disease : A Multi-Stakeholder Perspective to Improve Development of Drugs for Children ....
سنة النشر: 2023
الوصف: BACKGROUND AND AIMS: Despite recent approvals for new drugs to treat adults with Crohn's disease or ulcerative colitis, there are only two approved advanced treatment options [infliximab and adalimumab] for children with inflammatory bowel disease [IBD]. There are many potential new therapies being developed for adult and paediatric IBD. Moreover, regulatory agencies in both the European Union and USA have processes in place to support the early planning and initiation of paediatric studies. Nevertheless, unacceptable delays in approvals for use of drugs in children persist, with an average 7-year gap, or longer, between authorization of new IBD drugs for adults and children. METHODS: A 2-day virtual meeting was held during April 14-15, 2021 for multi-stakeholders [clinical academics, patient community, pharmaceutical companies and regulators] to discuss their perspectives on paediatric drug development for IBD. RESULTS: The multi-stakeholder group presented, discussed and proposed actions to achieve expediting the approval of new drugs in development for paediatric IBD. CONCLUSIONS: Collaborative action points for all stakeholders are required to make progress and facilitate new drug development for children with IBD.
نوع الوثيقة: article in journal/newspaper
وصف الملف: application/pdf
اللغة: English
DOI: 10.1093/ecco-jcc/jjac135
الاتاحة: https://pure.eur.nl/en/publications/557fd4fd-0e74-4060-9c04-8b295ed80eae
https://doi.org/10.1093/ecco-jcc/jjac135
https://pure.eur.nl/ws/files/87095639/Paediatric_Inflammatory_Bowel_Disease_A_Multi_Stakeholder_Perspective_to_Improve_Development_of_Drugs_for_Children_and_Adolescents.pdf
http://www.scopus.com/inward/record.url?scp=85150665432&partnerID=8YFLogxK
Rights: info:eu-repo/semantics/openAccess
رقم الانضمام: edsbas.E78ACE27
قاعدة البيانات: BASE
الوصف
DOI:10.1093/ecco-jcc/jjac135