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…

Acknowledgment for APICES collaboration in a GICOR trial published in Radiotherapy and Oncology

Androgen deprivation, Phase III, Prostate cancer, Radiotherapy, TestosteroneDeja un comentario

From APICES, we are privileged to share the acknowledgment that we have received in the recent publication titled “Prognostic value of testosterone castration levels following androgen deprivation and high-dose radiotherapy in localized prostate cancer: Results from a phase III trial” published in Radiotherapy and Oncology. We would like again to thank Almudena Zapatero and GICOR…

GESTO platform: Publication of results of observational studies with medicinal products for human use

AEMPS, APICES, Legislation, OBSERVATIONAL STUDY, Regulation, Royal DecreeDeja un comentario

After approval of the RD 957/2020 which regulates observational studies with medicinal products for human use it is mandatory the publication of results of observational studies with medicinal products for human use in the spanish clinical trials registry, as we mentioned in a previous post. Thus, the AEMPS with the aim to facilitate this process…

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…