It is a pleasure for APICES to cooperate with this multidisciplinary congress in head and neck cancer where clinical research is a must. Congrats to organisers, speakers, sponsors and attendees. Inicio – I Congreso de la FETTCC (fundacionttcc.com)
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…
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…
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 are not a code of conduct geared to Contract Research Organization (CRO). EUCROF has been working in a “Code of Conduct for Service Providers in…
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…
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 collaborated in several tasks of the project. This means to all APICES team an extra motivation in order to give continuity to the implication we have in every project in…
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 were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the…
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 their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are fundamental…
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…
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 global del beneficio de tratamiento que está siendo estudiado y de su relación beneficio- riesgo; pueden ser de dos tipos: Aquellos que, como los…