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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ICH Releases Draft Revision of E8 Guideline, General Considerations for Clinical Trials

Since the last update of ICH6 (R2) on 2017, ICH was working on a new release, a new revision of ICH E8 about General Considerations for Clinical Trials. The E8 last version was adopted in 1997, but changes to trial design and conduct in the last two decades have made much of the guideline out of date.

Currently, parties involved in clinical trials development have a draft version of ICH E8 available and ICH plans to release the final ICH E8(R1) by June 2020.

The new revision adds a new section about quality of clinical studies design which is focus on “critical to quality” factors adaptable to several types of clinical trials and the importance of patient centricity in clinical trial development.

Review complete draft version here: ICH E8(R1) Draft version

TO_logo

Acknowledgment for APICES collaboration in a clinical trial published in The Oncologist.

Many times the work of CROs is not totally acknowledged. But, fortunately, this is not always the case.

This month, we want to share the acknowledgment that APICES has received in a recent publication in The Oncologist. 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 ONCOSUR and Dr Eva Ciruelos for the opportunity they have given to APICES to appear as author as well as in the publication acknowledgments, and congratulate them for their project success.

The paper analyzes the results of a phase II clinical trial about neurotoxicity caused by three dose regimens of nab-paclitaxel in comparison with solvent-based paclitaxel as first line therapy. The clinical trial NEURABRAX has showed that, regardless of the dose, nab-paclitaxel did not differ from solvent-based-paclitaxel in terms of neurotoxicity as evaluated with the TNS. However, results from NCI-CTCAE, dose delays and reductions, and functional tools consistently indicate that 150 mg/m2 of nab-paclitaxel administered on days 1, 8 and 15 in a 4-week cycles is associated with a greater risk of chemotherapy-induced neuropathy. Thus, these results question the superiority of the TNS over NCI-CTCAE for evaluating chemotherapy-induced neuropathy and guiding treatment decisions in this context.

For more detailed information: A Pilot, Phase II, Randomized, Open‐Label Clinical Trial Comparing the Neurotoxicity of Three Dose Regimens of Nab‐Paclitaxel to That of Solvent‐Based Paclitaxel as the First‐Line Treatment for Patients with Human Epidermal Growth Factor Receptor Type 2‐Negative Metastatic Breast Cancer Ciruelos, et al. The Oncologist

blog

AEMPS UPDATES GCP SECTION

On April 24th 2019, AEMPS updated the contents of GCP section. Two points were updated:

  • New version of serious protocol breaches notification form.
  • Prohibition of FDA 1572 form in clinical trials carried out in Spain. Those clinical trials must follow Spanish laws 2001/20/EC, 2001/83/EC y 2005/28/EC and Regulation (EU) No. 536/2014 (when come into force). The non-compliance of this direction will be considered by inspectors a major finding attributable to clinical trial sponsor and principal investigator.

 

For more information:

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NEW TREATMENT OPTION FOR PATIENTS WITH SPINAL CORD INJURY

This month has been published a relevant article about a new therapeutic advance. A patient with spinal cord injury can walk again after being treated with NC1, a new cell therapy produced at Hospital Puerta de Hierro from Madrid, Spain.

The medical team from Hospital Puerta de Hierro started working in NC1 20 years ago. This therapy consists of expanded autologous mesenchymal stromal cells and autologous plasma as its excipient. APICES collaborated in project start-up and is proud of it. Congratulations to the Hospital Puerta de Hierro team and all the personnel involved who have made this possible.

For more information:

https://www.elmundo.es/salud/2019/03/01/5c79754b21efa04a668b45cf.html

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