Acknowledgement for APICES collaboration in DART 01/05 study published in «The Lancet Oncology»

Once more time we are privileged to share the acknowledgment that APICES has received in the recent publication titled: “High-dose radiotherapy and risk-adapted androgen deprivation in localized prostate cancer (DART 01/05): 10-year results of a phase 3 randomised, controlled trial”. This is an extra motivation for the whole APICES team. These achievements would not be…

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 leukemia”, published in Medicine International in which APICES has collaborated in several tasks of the project as design, setup, coordination and project management, monitoring, statistical analysis and preparation of the manuscript. This…

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 immune thrombocytopenia, with special focus on elderly patients” published in Blood Cells, Molecules, and Diseases in which APICES has collaborated in several tasks of the project. This means an extra motivation…

Acknowledgment for APICES collaboration in DUTRENEO study presented as ORAL PRESENTATION at ASCO 2020 Annual Meeting.

We want to share the acknowledgment that APICES has received in a recent ORAL PRESENTATION at the ASCO 2020 Annual Meeting by Dr. Enrique Grande. APICES has participated in medical writing monitoring, project management, safety, data management and statistics of the DUTRENEO study. This means an extra motivación to all APICES team in order to give continuity to the implication we…

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 (FDA) has revised the previous guidance on oncology endpoints published in May 2007. This guidance provides recommendations to applicants on endpoints for cancer…

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 human persons study, complies with several ethics requirements stablished in The Helsinki Declaration. All clinical trial protocol should be evaluated by…