GUIDANCE ON ONCOLOGY ENDPOINTS: FDA REVISION

GUIDANCE ON ONCOLOGY ENDPOINTS: FDA REVISION Clinical trial endpoints serve to different objectives: In early phase, clinical trials evaluate safety and evidence biological drug activity; for later phase efficacy studies evaluate the clinical benefit. Food and Drug Administration…

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BIOETHICS IN CLINICAL TRIALS

BIOETHICS IN CLINICAL TRIALS The participation of a human being in a clinical trial generates a potential situation of vulnerability in which his/her rights must keep clearly protected. It is necessary that any medical investigation, which involves the…

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Endpoints en ensayos clínicos: Ventajas y desventajas

Endpoints en ensayos clínicos: Ventajas y desventajas Los endpoints primarios en ensayos clínicos deben basarse en 3 requisitos: Ser clínicamente relevantes. Relacionados con el efecto del tratamiento. Medibles e interpretables. Los endpoints secundarios pueden aportar una visión más…

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