RESUMEN
Integrating precision diagnostics into personalized treatments requires understanding how biomarkers relate to clinical outcomes. Various clinical data collection methods exist, each with strengths and weaknesses. Interventional data are high quality but narrowly focused. Real-world data (RWD) provide broader information but with variable quality. Master protocols allow better efficiency in data collection. The master observational trial bridges the gap between interventional and retrospective RWD collection methods. To view this SnapShot, open or download the PDF.
Asunto(s)
Ensayos Clínicos como Asunto , Recolección de Datos , Medicina de Precisión , HumanosRESUMEN
This commentary introduces a new clinical trial construct, the Master Observational Trial (MOT), which hybridizes the power of molecularly based master interventional protocols with the breadth of real-world data. The MOT provides a clinical venue to allow molecular medicine to rapidly advance, answers questions that traditional interventional trials generally do not address, and seamlessly integrates with interventional trials in both diagnostic and therapeutic arenas. The result is a more comprehensive data collection ecosystem in precision medicine.
Asunto(s)
Estudios Observacionales como Asunto/métodos , Medicina de Precisión/métodos , Proyectos de Investigación/normas , Macrodatos , Protocolos de Ensayos Clínicos como Asunto , Humanos , Terapia Molecular Dirigida/métodos , Terapia Molecular Dirigida/tendencias , Estudios Observacionales como Asunto/normasRESUMEN
The Center for Medical Technology Policy and the Molecular Evidence Development Consortium gathered a diverse group of more than 50 stakeholders to develop consensus on a core set of data elements and values essential to understanding the clinical utility of molecularly targeted therapies in oncology.
Asunto(s)
Gestión de la Información en Salud , Neoplasias/genética , Elementos de Datos Comunes , Consenso , Bases de Datos de Ácidos Nucleicos , Genoma Humano , HumanosRESUMEN
Recent advances in molecularly targeted therapy and immunotherapy offer a glimmer of hope for potentially realizing the dream of personalized therapy for lung cancer. This article highlights current questions in clinical trial design, enrollment strategies and patient focused drug development, with particular emphasis on unique issues in trials of targeted therapy and immunotherapy.