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

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 are already  part of clinical practice.

From now on, the previous requirements to start the observational studies with medicines are limited to the favorable opinion of the CEIm and the agreement with the participating study sites, removing the classification by AEMPS.

In addition, in the prospective observational studies with medicines, it is possible for the Autonomous Communities to develop their own regulations based on their competences.

It is important to note that it will be mandatory to include prospective observational studies in the Spanish Clinical Trials Registry.

In the following link you can find all the information about this subject:

https://www.boe.es/diario_boe/txt.php?id=BOE-A-2020-14960

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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 to all APICES team in order to give continuity to the implication we have in every project in which we collaborate. APICES is proud of the recognition of our work and deliveries and we want to thank Dr. Lozano and Amgen S.A. Spain for the opportunity they have given to APICES to appear in the publication acknowledgments, and congratulate them and the rest of collaborating investigators for their project success.

This retrospective, multicenter study was aimed to analyze the implementation of current recommendations in the standard practice of adult ITP patients, and how age may influence those changes. Data reveal that there is a preferential use of TPO-RAs in elderly ITP patients with fewer bleeding complications.

For more detailed information: A decade of changes in management of immune thrombocytopenia, with special focus on elderly patients

DUTRENEO ASCO

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 studyThis means an extra motivación to all APICES team in order to give continuity to the implication we have in every project in which we collaborate. APICES is proud of the recognition of our work and deliveries and we want to thank both Dr. Enrique Grande and Fundación CRIS contra el Cáncer for including APICES in the acknowledgments section of the presentation, and congratulate them and the rest of collaborating investigators and patients and their families for the project success.

This clinical trial assesses the efficacy and safety of the combination of Durvalumab and Tremelimumab versus chemotherapy in patients with bladder cancer.

Clinical and Transalational Oncology

Acknowledgment for APICES collaboration in STREAM study published in Clinical and Translational Oncology.

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 which we collaborate. From APICES, we are pride because of the recognition of our work and we want to thank Dr. Enrique Aranda and Bayer Hispania S.L. for the opportunity they have given to APICES to appear in the publication acknowledgments, and congratulate them and the rest of collaborating investigators for their project success.

This retrospective, observational, multicenter study offers a description of the treatment patterns according to the type of treatment received by patients with metastatic colorectal cancer (mCRC) in Spain. Data reveal inconsistencies regarding adherence to the recommendations of the ESMO guidelines for the management of mCRC in Spain.

For more detailed information: Treatment patterns for metastatic colorectal cancer in Spain

Linkedin post 2019

Raising pharmacovigilance awareness in the #MedSafetyWeek

This week is the Annual Pharmacovigilance Week, organized by Uppsala Monitoring Center and led in Spain by Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

For one week in November, medicine regulators across the globe simultaneously share campaign materials on their social media channels, with the hashtag #MedSafetyWeek. The campaign of this year focuses on polypharmacy (which is defined as five or more medications) and the safe use of medicines in the elderly or those with complex conditions.

It has been published that currently one third of the world’s population over 75 years old take at least six medications per day, and more than one million people consume eight or more.

As a Contract Research Organization part of our work include monitoring clinical studies in which patient have a special conditions (most of them suffer chronic diseases and usually are elderly patients), therefore we need to be aware of this condition can increase the likelihood of suffer adverse drug reactions.

For more detailed information: La AEMPS celebra la #MedSafetyWeek con una campaña para sensibilizar sobre la importancia de notificar las sospechas de reacciones adversas a medicamentosmedsafetyweek

Scientific Reports

Acknowledgment for APICES collaboration in a clinical trial published in Scientific Reports.

This month, we want to share the acknowledgment that APICES has received in a recent publication in Scientific Reports 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 which we collaborate. From APICES, we are pride because of the recognition of our work and we want to thank Dr. María Luisa Lozano and Dr. Vicente Vicente for the opportunity they have given to APICES to appear in the publication acknowledgments, and congratulate them and the rest of collaborating invetigators for their project success.

This retrospective multicenter study with long-term follow-up offers insight into some of the most relevant real-world challenges in the treatment of ITP patients with thrombopoietin-receptor agonist (TPO-RA). Data reflect that in clinical practice, the patient’s hemorrhagic risk determines the choice TPO-RA, and distinguishes novel variables associated with vascular events under therapies with thrombopoietic agents.

For more detailed information: Deciphering predictive factors for choice of thrombopoietin receptor agonist, treatment free responses, and thrombotic events in immune thrombocytopenia

AECIC

VIII AECIC SUMMIT: EU 536/2014 CLINICAL TRIAL REGULATION

AECIC (Asociación Española de Compañías de Investigación Clínica/Spanish association of CROs) is aware of the continuous development and innovation in clinical research. Thus, it is necessary to include improvements and changes in daily processes in order to enhance working results and follow the evolution of clinical research.

For this reason, on November 12th 2019, AECIC is offering a conference session about EU 536/2014 Regulation for clinical trials of medicinal products for human, next steps for 2020. In this session, it will be discussed the state of the art from several points of view as Spanish and European Health Authorities, Pharmaceutical Companies, CROs and Health Institutions.

For more information: VIII Jornadas AECIC – Aplicación del Reglamento UE 536/2014 de ensayos clínicos.

bmc

Acknowledgment for APICES collaboration in a clinical trial published in BMC Cancer.

This month, we want to share the acknowledgment that APICES has received in a recent publication in BMC Cancer 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 which we collaborate. From APICES, we are proud because of the recognition of our work and we want to thank Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), Dr. Alfredo Carrato and Dr. Enrique Grande for the opportunity they have given to APICES to appear in the publication acknowledgments, and congratulate them for their project success.

The study asses the efficacy and safety of regorafenib when is administered in first-line to frail patients with advanced colorectal cancer (CRC) through a pilot phase II trial.

For more detailed information: https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5753-7

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly.    REUTERS/Jason Reed   (UNITED STATES HEALTH) - RTXQCTX

EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES

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 EMA and FDA between 2014 and 2016.

The result of the analysis is the EMA and FDA alignment in more than 90% of marketing authorization decisions for new medicines. The most common reasons for discordance were differences in conclusions about efficacy and differences in clinical data submitted in support of an application.

For more information: EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

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

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 for the protection and promotion of public health.

EMA has since September 2018 been identifying trials with missing results on a monthly basis and sending reminders to the sponsors of those trials to ensure compliance with the transparency rules and their follow up on their results reporting obligations.

For more information: https://www.ema.europa.eu/en/news/call-all-sponsors-publish-clinical-trial-results-eu-database

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