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

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

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

ICH-logo-large

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:

20190313

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

eudravigilance

Comunicación de Reacciones Adversas a Medicamentos a eudravigilance.

Desde el pasado día 22 de noviembre de 2017 está disponible la nueva versión de EudraVigilance y comenzó un nuevo flujo de envío de sospechas de reacciones adversas a medicamentos en la Unión Europea. Esto implica que según lo que establece el Real Decreto 577/2013, por el que se regula la farmacovigilancia de medicamentos de uso humano, los titulares de autorización de comercialización (TAC) deben enviar por medios electrónicos a la base de datos EudraVigilance todas las sospechas de casos individuales de reacciones adversas a medicamentos tanto graves como no graves, atendiendo a las directrices europeas sobre buenas prácticas de Farmacovigilancia.

Esto quiere decir que es obligatorio el envío por parte de los TAC, de todas las sospechas de reacciones adversas graves ocurridas en la Unión Europea y en terceros países, en los quince días naturales siguientes al día en el que haya tenido conocimiento de éstas. Y por otra parte, también tiene obligación de enviar todas las sospechas de reacciones adversas no graves ocurridas en la Unión Europea en los noventa días naturales siguientes al día en el que haya tenido conocimiento de éstas.

En el departamento de Farmacovigilancia de APICES, estamos al día de este cambio de flujo y teniendo en cuenta que sólo es de aplicación en el ámbito post-autorización, nos afecta solamente en aquellos casos de reacciones adversas a medicamentos procedentes de estudios post-autorización (no ensayos clínicos) en los que se requiera notificación por parte de los TAC.

Para más información, se pueden consultar los siguientes enlaces:

https://sede.aemps.gob.es/usoHum/farmacovig/docs/preg_resp-transicion-flujo-EudraVigilance.pdf

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000165.jsp&mid=WC0b01ac0580a69263

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Actualización de los criterios de selección de pacientes en ensayos clínicos

Estimados amigos,

En el recientemente celebrado congreso anual de la Asociación Americana de Oncología Clínica (ASCO) se ha presentado un trabajo en el que ASCO, Friends of Cancer Research y la FDA utilizaron las recomendaciones del trabajo original de ASCO para identificar los criterios de elegibilidad que con mayor probabilidad restringirían la participación de los pacientes en los ensayos y tenían menos probabilidades de afectar la seguridad de los participantes.

La intención es incluir un mayor número de pacientes de los que suelen estar poco representados en los ensayos clínicos. Pacientes pediátricos, personas con tumores previos o concurrentes, individuos con metástasis cerebrales y portadores del VIH podrán ser incluidos en los ensayos clínicos, ampliando la población de sujetos candidatos a formar parte de estos estudios.

En el vínculo siguiente se puede ver un resumen de cada una de las recomendaciones del grupo de trabajo y un análisis de los principios generales para guiar su implementación. Además incluye el lenguaje recomendado para su uso en protocolos de ensayos clínicos.

http://ascopubs.org/

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