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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

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

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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

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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

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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

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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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