RESUMO
There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.
Assuntos
Comitês de Monitoramento de Dados de Ensaios Clínicos/organização & administração , Comitês de Ética em Pesquisa/organização & administração , Prova Pericial , Padrões de Prática Médica/estatística & dados numéricos , Pesquisa Biomédica , Comitês de Monitoramento de Dados de Ensaios Clínicos/ética , Comitês de Monitoramento de Dados de Ensaios Clínicos/estatística & dados numéricos , Coleta de Dados , Comitês de Ética em Pesquisa/ética , Comitês de Ética em Pesquisa/estatística & dados numéricos , Feminino , Humanos , Masculino , Inquéritos e Questionários , Estados UnidosRESUMO
The recent financial meltdown has muted the patent reform debate in the United States. But given that President Obama, as well as many members of Congress, support patent reform, we expect the debate to resurface. In this essay, we look carefully at reports from three prestigious organizations which have been enormously influential in the debate. We examine the empirical basis contained in these reports upon which proposed legislative changes are based. We conclude that the empirical data being used to justify the need for reform either has serious methodological limitations or is non-existent. Moreover, we review recent court decisions which have already altered the patent environment calling into further question whether the limited data that exists is still applicable. The effect of these recent decisions has not been adequately evaluated or assessed. Thus, we recommend other empirical studies are needed to inform public policy as to whether patent reform is necessary.
Assuntos
Patentes como Assunto , Política Pública , Organizações , Estados UnidosRESUMO
The perception of rising litigation rates is driving the push for patent reform.
Assuntos
Biotecnologia/legislação & jurisprudência , DNA/química , Patentes como Assunto/legislação & jurisprudência , Algoritmos , Tecnologia Biomédica/legislação & jurisprudência , Biotecnologia/tendências , Bases de Dados Factuais , Propriedade Intelectual , Estados UnidosRESUMO
A new law intended to promote collaborative research may end up costing the biotech industry more and inhibiting innovation.