Acknowledgement for APICES collaboration in FDO-LMA-2016-01 study published in “Medicine International” This month, we want to share the acknowledgment that APICES has received in the recent publication titled “Biomarker-driven phase IB clinical trial of OPB-111077 in acute myeloid…
NEW DATA PROTECTION CODE OF CONDUCT BY EUCROF Procedure and technical measures in order to comply with General Data Protection Regulation 2016/679 are being more and more standardized through codes of conduct in several fields. Until now, there…
Acknowledgment for APICES collaboration in a study published in Blood Cells, Molecules, and Diseases. This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A decade of changes in management of…
Acknowledgment for APICES collaboration in STREAM study published in Clinical and Translational Oncology. This month, we want to share the acknowledgment that APICES has received in a recent publication in Clinical and Translational Oncology in which APICES has…
EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information…
Call for all sponsors to publish clinical trial results in EU database The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of…
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…
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…
Actualización de los criterios de selección de pacientes en ensayos clínicos Estimados amigos, En el recientemente celebrado congreso anual de la Asociación Americana de Oncología Clínica (ASCO) se ha presentado un trabajo en el que ASCO, Friends of…
El VIII Seminario Fundación ECO, organizado de manera conjunta con la Real Academia Nacional de Medicina, ofreció un foro de debate y discusión en esta ocasión, sobre la evaluación y los resultados de salud en Oncología. Oscar Salamanca, director…
