Asunto(s)
Antiinfecciosos/uso terapéutico , Ensayos Clínicos como Asunto/métodos , Proteína C/uso terapéutico , Proteínas Recombinantes/uso terapéutico , Sepsis/tratamiento farmacológico , APACHE , Antiinfecciosos/efectos adversos , Línea Celular , Comorbilidad , Aprobación de Drogas , Hemorragia/inducido químicamente , Humanos , Proteína C/efectos adversos , Proteínas Recombinantes/efectos adversos , Sepsis/clasificación , Análisis de Supervivencia , Estados Unidos , United States Food and Drug AdministrationRESUMEN
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.
Asunto(s)
Biotecnología , Ensayos Clínicos como Asunto/normas , Proyectos de Investigación , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados , Fibrinolíticos/uso terapéutico , Terapia Genética , Humanos , Infarto del Miocardio/tratamiento farmacológico , Ornitina Carbamoiltransferasa/genética , Ornitina Carbamoiltransferasa/uso terapéutico , Enfermedad por Deficiencia de Ornitina Carbamoiltransferasa/terapia , Síndrome de Respuesta Inflamatoria Sistémica/tratamiento farmacológicoRESUMEN
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.