Assuntos
Leis Antitruste , União Europeia , União Europeia/organização & administração , Animais , Humanos , Reino UnidoAssuntos
Cidades , Planejamento de Cidades , Planejamento Ambiental , Árvores , Abastecimento de Água , União Europeia/organização & administração , Árvores/crescimento & desenvolvimento , Árvores/metabolismo , Água/metabolismo , Planejamento de Cidades/tendências , Planejamento Ambiental/tendências , Região do Mediterrâneo , BiodiversidadeAssuntos
União Europeia , Pesquisadores , Apoio à Pesquisa como Assunto , Pesquisa , União Europeia/economia , União Europeia/organização & administração , Reino Unido , Pesquisadores/economia , Pesquisadores/legislação & jurisprudência , Apoio à Pesquisa como Assunto/economia , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Pesquisa/economia , Pesquisa/legislação & jurisprudênciaRESUMO
The first (2017) and sixth (2021) multistakeholder Paediatric Strategy Forums focused on anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies. ALK is an important oncogene and target in several paediatric tumours (anaplastic large cell lymphoma [ALCL], inflammatory myofibroblastic tumour [IMT], neuroblastoma and hemispheric gliomas in infants and young children) with unmet therapeutic needs. ALK tyrosine kinase inhibitors have been demonstrated to be active both in ALK fusion-kinase positive ALCL and IMT. ALK alterations differ, with fusions occurring in ALCL, IMT and gliomas, and activating mutations and amplification in neuroblastoma. While there are many ALK inhibitors in development, the number of children diagnosed with ALK driven malignancies is very small. The objectives of this ALK Forum were to (i) Describe current knowledge of ALK biology in childhood cancers; (ii) Provide an overview of the development of ALK inhibitors for children; (iii) Identify the unmet needs taking into account planned or current ongoing trials; (iv) Conclude how second/third-generation inhibitors could be evaluated and prioritised; (v) Identify lessons learnt from the experience with ALK inhibitors to accelerate the paediatric development of other anti-cancer targeted agents in the new regulatory environments. There has been progress over the last four years, with more trials of ALK inhibitors opened in paediatrics and more regulatory submissions. In January 2021, the US Food and Drug Administration approved crizotinib for the treatment of paediatric and young adult patients with relapsed or refractory ALCL and there are paediatric investigation plans (PIPs) for brigatinib and for crizotinib in ALCL and IMT. In ALCL, the current goal is to investigate the inclusion of ALK inhibitors in front-line therapy with the aim of decreasing toxicity with higher/similar efficacy compared to present first-line therapies. For IMT, the focus is to develop a joint prospective trial with one product in children, adolescents and adults, taking advantage of the common biology across the age spectrum. As approximately 50% of IMTs are ALK-positive, molecular analysis is required to identify patients to be treated with an ALK inhibitor. For neuroblastoma, crizotinib has not shown robust anti-tumour activity. A focused and sequential development of ALK inhibitors with very good central nervous system (CNS) penetration in CNS tumours with ALK fusions should be undertaken. The Forum reinforced the strong need for global academic collaboration, very early involvement of regulators with studies seeking possible registration and early academia-multicompany engagement. Innovations in study design and conduct and the use of 'real-world data' supporting development in these rare sub-groups of patients for whom randomised clinical trials are not feasible are important initiatives. A focused and sequenced development strategy, where one product is evaluated first with other products being assessed sequentially, is applicable for ALK inhibitors and other medicinal products in children.
Assuntos
Quinase do Linfoma Anaplásico/antagonistas & inibidores , Desenvolvimento de Medicamentos/organização & administração , Colaboração Intersetorial , Neoplasias/tratamento farmacológico , Inibidores de Proteínas Quinases/uso terapêutico , Quinase do Linfoma Anaplásico/genética , Criança , Ensaios Clínicos como Assunto , Indústria Farmacêutica/organização & administração , União Europeia/organização & administração , Humanos , Cooperação Internacional , Oncologia/organização & administração , Neoplasias/genética , Pediatria/organização & administração , Inibidores de Proteínas Quinases/farmacologia , Estados Unidos , United States Food and Drug Administration/organização & administraçãoRESUMO
Brexit has resulted in some key changes to the regulation of veterinary medicines, as the Veterinary Medicines Directorate explains.
Assuntos
União Europeia/organização & administração , Legislação Veterinária , Drogas Veterinárias , Animais , Humanos , Reino UnidoAssuntos
União Europeia , Aquecimento Global/economia , Aquecimento Global/prevenção & controle , Cooperação Internacional , Dióxido de Carbono/análise , China , União Europeia/economia , União Europeia/organização & administração , Cooperação Internacional/legislação & jurisprudência , Política , Impostos , Estados UnidosRESUMO
The coronavirus disease 2019 (COVID-19) pandemic and the accompanying control measures have significantly affected clinical trial (CT) conduct, and sponsors have needed to make rapid changes to their CT operations. As a result, regulatory guidance was pivotal during the initial phases of the pandemic. This study aimed to evaluate the regulatory readiness and guidance related to COVID-19 in the European Union (EU). The European Medicines Agency (EMA) and national competent authorities' (NCAs') websites were searched in September and October 2020 for guidances on the management of CTs during the pandemic published from January 2020 onward. "Regulatory readiness" was defined as the number of days from the first European COVID-19 case (January 24, 2020) to the first published guidance by the respective NCA. "Regulatory guidance" was evaluated by coding the guidances for the following predefined operational trial activities important for ongoing CTs: obtaining informed consent, participant information, clinic visits, home health visits, telemedicine visits, self-monitoring, investigational medicinal product (IMP) supply, IMP adherence monitoring, CT monitoring, documentation management, regulatory management, and safety management. Twenty-four of the 27 EU NCAs published country-specific guidance. The time from the first European COVID-19 case to the first published EMA guidance was 56 days and ranged from 47 to 66 days for the first national guidances. Guidance was provided most frequently for regulatory management (24/24), safety management (23/24), documentation management (22/24), and CT monitoring (22/24). The regulatory guidance provided during the pandemic, ensuring participant safety and data integrity, may now be the starting point to innovate future CT conduct.
Assuntos
Tratamento Farmacológico da COVID-19 , COVID-19/epidemiologia , Ensaios Clínicos como Assunto/organização & administração , Aprovação de Drogas/organização & administração , União Europeia/organização & administração , Ensaios Clínicos como Assunto/normas , Tomada de Decisões , Humanos , Adesão à Medicação , Pandemias , Projetos de Pesquisa , SARS-CoV-2 , Telemedicina , Fatores de TempoAssuntos
União Europeia/economia , Organização do Financiamento/economia , Organização do Financiamento/tendências , Apoio à Pesquisa como Assunto/economia , Apoio à Pesquisa como Assunto/tendências , Pesquisa/economia , Pesquisa/tendências , COVID-19 , Gerenciamento de Dados/economia , Empreendedorismo/economia , Europa (Continente) , União Europeia/organização & administração , Feminino , Objetivos , Humanos , Disseminação de Informação , Cooperação Internacional , Masculino , Publicação de Acesso Aberto/economia , Pesquisa/organização & administração , Pesquisadores/economia , Sexismo/prevenção & controle , Transferência de TecnologiaAssuntos
Comércio/legislação & jurisprudência , União Europeia/economia , União Europeia/organização & administração , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Ciência/economia , Ensaios Clínicos como Assunto , Comércio/economia , Emigração e Imigração/legislação & jurisprudência , Equipamentos e Provisões/economia , Organização do Financiamento/economia , Organização do Financiamento/organização & administração , Produto Interno Bruto , Física , Pesquisadores/economia , Pesquisadores/legislação & jurisprudência , Pesquisadores/organização & administração , Voo Espacial , Reino UnidoRESUMO
European Union (EU) fiscal governance, especially the European Semester, is an ambitious new governance architecture involving surveillance and discipline, across both Eurozone and non-Eurozone member state policies, in pursuit of fiscal rigor. It is the most recent of several attempts to expand EU powers over member state policy with the goal of austere budgeting, and one that has led to remarkable claims of authority by the EU over member state health policies as detailed as medical school admissions and the role of primary care. It is expected that it would be resisted not just by those who object to an EU role in the organization and delivery of health care but also by those who object to a particular austere approach to health policy. How well is it working? Using two waves of interviews and documentary analysis, and health as a policy case study, the authors document three key techniques that opponents use to undermine the semester's governance architecture: broadening goals, expanding the scope of conflict, and disputing and nuancing indicators. The result is that opponents of a narrow fiscal governance agenda are again successfully undermining the narrow focus of the semester.