Assuntos
Indústria Farmacêutica/economia , Financiamento Governamental , Vacinas/provisão & distribuição , Adulto , Criança , Custos e Análise de Custo , Indústria Farmacêutica/legislação & jurisprudência , Reforma dos Serviços de Saúde , Humanos , Cobertura do Seguro , Seguro Saúde , Responsabilidade Legal , Controle de Qualidade , Estados Unidos , Vacinas/economia , Vacinas/normasRESUMO
Comparative effectiveness research (CER) is meant to provide evidence about the relative risks and benefits of different treatment options. It is gaining visibility as a tool to address the evidence gaps that clinicians struggle with every day; however, CER is particularly challenging in oncology as there is great variability in how individuals respond to interventions, and a wide range of drugs and procedures are available. In order to overcome these obstacles and conduct reliable CER studies, it is critical to create a robust data infrastructure to support it.The Center for Medical Technology Policy held its first annual CER Summit in November 2010, with a particular focus on oncology. A number of critical informatics themes emerged including the need for consistent data standards, registry reform, tools to assist trial accrual, and data to integrate into value deliberations. Addressing the data issues highlighted in this report will provide a significant opportunity to improve the health of our medical system.
Assuntos
Pesquisa Comparativa da Efetividade , Registros Eletrônicos de Saúde , Informática Médica/tendências , Oncologia/normas , Análise Custo-Benefício/economia , Humanos , Sistemas Computadorizados de Registros Médicos/normas , Risco , Resultado do TratamentoRESUMO
A key tenet of comparative effectiveness research is that it should be conducted in real-world health care settings. This article addresses a basic question: What is the capacity of the clinical research enterprise to conduct such studies? We argue that the clinical trial system is already at capacity and will not be able to absorb large amounts of comparative effectiveness research without diverting resources from other needs. We propose a federally funded national clinical research infrastructure that would increase comparative effectiveness research capacity by encouraging community-based clinicians and their patients to participate in trials.
Assuntos
Participação da Comunidade , Pesquisa Comparativa da Efetividade/organização & administração , Projetos de Pesquisa , Pesquisa Comparativa da Efetividade/economia , Financiamento Governamental , Estados UnidosRESUMO
Despite the great promise of immunization and recent progress in immunizing children throughout the developing world, a global crisis in vaccine R&D, supply and delivery is faced. This article reviews how the global US6 billion dollars vaccine market is structured and its attractiveness to vaccine suppliers, the international two-tiered pricing system in which high-income countries generate about 82% of vaccine revenues but represent only 12% of the doses, the impact of schedule divergence as high-income and developing countries introduce different vaccines, the role of the US government, and possible approaches to ameliorate the crisis.