Assuntos
Anti-Infecciosos/uso terapêutico , Ensaios Clínicos como Assunto/métodos , Proteína C/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Sepse/tratamento farmacológico , APACHE , Anti-Infecciosos/efeitos adversos , Linhagem Celular , Comorbidade , Aprovação de Drogas , Hemorragia/induzido quimicamente , Humanos , Proteína C/efeitos adversos , Proteínas Recombinantes/efeitos adversos , Sepse/classificação , Análise de Sobrevida , Estados Unidos , United States Food and Drug AdministrationRESUMO
Not surprisingly, clinical trials have been critically important to developments in the field of biotechnology. Perhaps less expectedly, the clinical trials of biotechnology products have been critically important to recent developments in the field of clinical trials design, conduct, and analysis. This manuscript explores three examples of biotechnology clinical trials--a trial in sepsis, a trial in fibrinolytics in myocardial infarction, and trials in gene therapy--and highlights their contributions to the theory and practice of clinical research.
Assuntos
Biotecnologia , Ensaios Clínicos como Assunto/normas , Projetos de Pesquisa , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Fibrinolíticos/uso terapêutico , Terapia Genética , Humanos , Infarto do Miocárdio/tratamento farmacológico , Ornitina Carbamoiltransferase/genética , Ornitina Carbamoiltransferase/uso terapêutico , Doença da Deficiência de Ornitina Carbomoiltransferase/terapia , Síndrome de Resposta Inflamatória Sistêmica/tratamento farmacológicoRESUMO
This discussion considers arguments for and against separating responsibility for the unblinded interim analysis of a clinical trial from responsibility for trial management and modifications to the ongoing trial. The degree to which one or different statisticians carry out these responsibilities and thus the degree of statistician independence for the two activities can vary, but a sponsor should recognize that giving a single statistician both responsibilities might limit flexibility in managing the trial, particularly with respect to modifying an ongoing trial.