Acknowledgement for APICES collaboration in study ABIDO published in » European Journal of Cancer»

APICES, Clinical Trials, Metastatic castration-resistant prostate cancer, Project management, Publications, RandomisedDeja un comentario

This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial”. published in…

Acknowledgement for APICES collaboration in DERMIA study published in «Supportive Care in Cancer»

anti-EGFR, APICES, Clinical Trials, Metastatic Colorectal Cancer, Skin ToxicityDeja un comentario

This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A phase 2 study for evaluating doxycycline 50 mg once daily and 100 mg once daily as preemptive treatment for skin toxicity in patients with metastatic colorectal cancer treated with an anti-EGFR and chemotherapy” published in Supportive Care in…

Acknowledgement for APICES collaboration in ABACUS trial published in «European Urology»

APICES, Clinical Trials, Muscle-invasive bladder cancer, Neoadjuvant immunotherapy, personalized medicine, PublicationsDeja un comentario

Once more time we are privileged to share the acknowledgment that APICES has received in the recent publication titled: “Final Results of Neoadjuvant Atezolizumab in Cisplatin-ineligible Patients with Muscle-invasive Urothelial Cancer of the Bladder”. This is an extra motivation for the whole APICES team. These achievements would not be possible without the involvement of every…

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

Androgen deprivation therapy, APICES, Clinical Trials, Phase III, Prostate cancer, Publications, Radiotherapy, RandomisedDeja un comentario

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…

Acknowledgment for APICES collaboration in PROBIOTIC trial published in Pharmaceuticals

AEMPS, APICES, Clinical Trials, Fibromyalgia, Quality of LifeDeja un comentario

From APICES, we are privileged to share the acknowledgment that we have received in the recent publication titled: “Efficacy and Tolerability of the Probiotic VSL#3 for the Treatment of Patients with Fibromyalgia and Associated Gastrointestinal Symptomatology; A Randomized Double-blind Clinical trial” published in Pharmaceuticals related with one study which APICES has collaborated in the statistical analysis. We…

CLINICAL TRIALS REGULATION (EU) 536/2014 IMPLEMENTATION TRAINING

Clinical Trials, EMA, RegulationDeja un comentario

Last month, The European Commission, Clinical Trials Facilitation and Coordination Group and European Medicines Agency (EC-DG SANTE/HMA-CTFG/EMA) imparted a joint training on the Clinical Trials Regulation (EU) 536/2014. The implementation to a European level implies a Harmonization of the submission of a clinical trial from all Member States of the part I documentation: documentation to…

Acknowledgment for APICES collaboration in BIBABRAX Study published in Cancer Chemotherapy and Pharmacology

AEMPS, APICES, ASCO, Clinical Trials, Deterioration-Free Survival, Gemcitabine, Nab-Paclitaxel, Phase II, Quality, Quality of LifeDeja un comentario

Once again, we are privileged to share the acknowledgment that APICES has received in the recent publication titled «Phase II clinical trial of nab‑paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study»  published in Cancer Chemotherapy and Pharmacology and related with one study conducted by APICES, which has…

New regulation for observational studies with medicines for human use in Spain

AEMPS, BOE, Clinical Trials, Environment, Legislation, OBSERVATIONAL STUDY, RegulationDeja un comentario

Last week, the Royal Decree 957/2020 which regulates the observational studies with medicines for human use was published in the BOE. This regulation will come into force on January 2, 2021 aims to simplify the procedures regulated by the Order SAS/3470/2009 taking into account the observational nature of these type of studies with drugs that…