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Clin Pharmacol Ther ; 105(4): 857-866, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30610746


Efficacy trials, designed to gain regulatory marketing approval, evaluate drugs in optimally selected patients under advantageous conditions for relatively short time periods. Effectiveness trials, designed to evaluate use in usual practice, assess treatments among more typical patients in real-world conditions with longer follow-up periods. In "efficacy-to-effectiveness (E2E) trials," if the initial efficacy trial component is positive, the trial seamlessly transitions to an effectiveness trial component to efficiently yield both types of evidence. Yet more time could be saved by simultaneously addressing efficacy and effectiveness in an "efficacy and effectiveness too (EE2) trial." Additionally, hybrids of the E2E and EE2 approaches with differing degrees of overlap of the two components could allow flexibility for specific drug development needs. In planning EE2 trials, each stakeholder's current and future needs, incentives, and perspective must be considered. Although challenging, the ultimate benefits to stakeholders, the health system, and the public should justify this effort.

Ensaios Clínicos como Assunto/legislação & jurisprudência , Aprovação de Drogas/legislação & jurisprudência , Desenvolvimento de Medicamentos/legislação & jurisprudência , Projetos de Pesquisa/legislação & jurisprudência , Análise Custo-Benefício/legislação & jurisprudência , Humanos , Marketing/legislação & jurisprudência , Seleção de Pacientes , Resultado do Tratamento
Politics Life Sci ; 28(2): 2-26, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20205520


Synthetic biology seeks to create modular biological parts that can be assembled into useful devices, allowing the modification of biological systems with greater reliability, at lower cost, with greater speed, and by a larger pool of people than has been the case with traditional genetic engineering. We assess the offensive and defensive security implications of synthetic biology based on the insights of leading synthetic biologists into how the technology may develop, the projections of practicing biosecurity authorities on changes in the security context and potential security applications of synthetic biology, and joint appraisals of policy relevant sources of uncertainty. Synthetic biology appears to have minimal security implications in the near term, create modest offensive advantages in the medium term, and strengthen defensive capabilities against natural and engineered biological threats and enable novel potential offensive uses in the long term. To maximize defensive and minimize offensive effects of synthetic biology despite uncertainty, this essay suggests a combination of policy approaches, including community-based efforts, regulation and surveillance, further research, and the deliberate design of security and safety features into the technology.

Biotecnologia , Medidas de Segurança , Técnicas Biossensoriais , Entrevistas como Assunto , Formulação de Políticas , Literatura de Revisão como Assunto , Incerteza