Acknowledgment for APICES collaboration in PROBIOTIC trial published in Pharmaceuticals

AEMPS, APICES, Clinical Trials, Fibromyalgia, Quality of Life

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…

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

AEMPS, APICES, Legislation, OBSERVATIONAL STUDY, Regulation, Royal Decree

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…

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 Life

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, Regulation

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…

Call for all sponsors to publish clinical trial results in EU database

AEMPS, Clinical Trials, EMA, Legislation, Regulación, Regulation

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…