PARIS (31 January 2017) – The European Clinical Research Infrastructure Network (ECRIN) has announced the launch of the Paediatric Clinical Research Infrastructure Network (PedCRIN). The three-year project brings together ECRIN and the founding partners of the European Paediatric Clinical Trial Research Infrastructure (EPCT-RI) to develop capacity for the management of multinational paediatric clinical trials. Children represent 20% of the European population and their health is a major societal challenge for Europe and the world, requiring the development of evidence-based paediatric medicines and treatment strategies. Yet, there is a current lack of data specific to neonates, infants and children; over 50% of the medicines used in these groups have not been tested on them specifically, but rather, on adults. This is problematic as neonates/infants/children and adults differ widely in many ways, from their physiology to their metabolic pathways. […]
Access to the drug and reimbursement: a two-speed Europe? We talked about it to Dr. Enrico Bosone, president of SIAR (Italian Society for Regulatory Activities), a non-profit organization whose membership comprises about 200 professionals in Italy involved in regulatory activities related to the regulation of those products, including drugs, which require a production and/or marketing authorisation provided by Health Authority. The association’s objectives are to study and understand the regulation in the field of drugs, medical devices, food and food supplements, as well as the constant updating about laws and documents issued by the Italian, European and non European authorities, and the promotion of cooperation with the competent authorities and public and private institutions involved in the regulatory activities. To achieve these objectives, SIAR has established several working groups: the first deals with the R & D and has published a practical manual on clinical trials in Italy; the second deals with medical and scientific information, and organizes seminars to disseminate the results of the scientific activities; the third deals with access to the drug by patients. What is meant by "access to the drug?". "In the European Union, access means reimbursement" - explains Dr. Bosone, "This is because the medicines, especially the most innovative ones, are often expensive and, in principle, are reimbursed by the National Health Service in each country, which supplies them to patients free of charge or by a modest ticket payment (as in Italy). It happens, however, that normally a delay is generated between the marketing authorization and the reimbursement, or the availability of the drug to the patients, which in Europe varies from country to country. In fact there are two types of marketing authorization", clarifies Dr. Bosone,"the first [...]
“The Italian Multiregional Thalassemia Registry: centers characteristics, services and patients’ population”, published on Hematology
The results of the project “HTA-Thal, Inter-regional Network for Thalassemia: HTA for the diagnostic and therapeutic intervention for iron overload”, a public funded project promoted in 2008 by the Minister of Health, has been published on Hematology. The project, co-funded by Fondazione Giambrone and coordinated by the Region of Basilicata, was aimed at creating a “Multiregional Network of Thalassemia centers’’, including an inventory of services and tools available at each participating center, and setting up a Thalassemia Registry (HTA-THAL Registry), with epidemiological and clinical data on the Thalassemia population referring to those centers. The article "The Italian Multiregional Thalassemia Registry: centers characteristics, services and patients’ population" is available at: http://www.tandfonline.com/doi/abs/10.1080/10245332.2015.1101971. The full text can be requested at the following email: [email protected] More information on the CVBF’s research activities, are available at the dedicated "Scientific Research" page.
On June, 2015, the chapter entitled "Clinical Trials in Paediatrics — Regulatory and Methodological Aspects" and included in the book Drug Discovery and Development - From Molecules to Medicine, ISBN 978-953-51-2128-2, edited by Omboon Vallisuta and Suleiman Olimat has been released online. This chapter has been written with the contribution of Adriana Ceci, Viviana Giannuzzi, , Donato Bonifazi, Mariagrazia Felisi Fedele Bonifazi and Lucia Ruggieri on behalf of TEDDY-CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche). The aim of this chapter is to describe the requirements for implementing paediatric clinical trials in compliance with the principles of Good Clinical Practice (GCP), in order to be part of an approved PIP (Paediatric Investigational Plan-EMA) or PSP (Paediatric Study Plan-FDA). The chapter addressed the main three topics of a paediatric clinical trial: the regulatory aspects, the paediatric plans and paediatric trials methodology and the incentives provided by the existing legislation and the main results achieved by today. The chapter also explores the distribution and the other characteristics of recently conducted paediatric trials in Europe and in the United States, also providing a comparison between the two areas. At this link you can get access to the full article.
The Open Meeting of the DEEP (DEferiprone Evaluation in Paediatrics) project will be held in Tirana at the Hotel Tirana International on May 18th, 2015 DEEP is a 4-year European research Project (FP7) coordinated by CVBF and comprises 28 recruiting sites located in 5 European Countries (Albania, Cyprus, Greece, Italy and United Kingdom) and 5 non-European Countries (Egypt, Lebanon, Marocco, Tunisia and Turkey), 16 scientific partners and a pharmaceutical group based in Canada. The Open Meeting is promoted by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with University Hospital Center “Mother Teresa” (UHCT) and will be the occasion to raise the attention on the progresses achieved by the clinical research in Albania and the importance of the European Networks to create synergies to spread excellence and attract European funding. […]
On December 10th 2014, a press conference was held at the rectorate of the University of Bari Aldo Moro with the aim to sign the framework agreement for the scientific collaboration between the University of Bari (UniBA), the Gianni Benzi Pharmacological Research Foundation (FGB) and the Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF). On that occasion, Prof. Antonio Felice Uricchio as Dean of the University of Bari “Aldo Moro”, Prof. Adriana Ceci as President of FGB and Mr. Donato Bonifazi as CEO of CVBF and Prof. Adriana Ceci as President of FGB undertook to cooperate in carrying out scientific research activities foreseen in the framework of the EU-funded projects (FP7 and Health Programme) in which FGB and CVBF are Partners. In particular, the scientific research activities will involve the following departments at the University of Bari: Department of Biomedical Sciences and Human Oncology; Department of Pharmacy-Pharmaceutical Sciences; Department of Biosciences, Biotechnology and Biopharmaceutical; Department of Basic Medical Sciences, neuroscience and sense organs; Department of Political Science.
The Italian Medicines Agency (AIFA) has published the 13th National Report on Clinical Trials of Drugs in Italy, which contains data from 2013 and provides a clear and objective picture of the clinical trials in Italy, highlighting the presence of centres performing clinical trials in the field of pharmacology, the types of research conducted and the distribution of the Ethics Committees. Despite the global economic crisis that caused a clear decrease in the number of clinical trials (CTs) as well as in the number of patients enrolled in Europe, data show that Italy has maintained in 2013 its share in the research field, with a number of 623 CTs, estimated by AIFA. More than the 10% of the clinical trials performed in Italy is represented by phase I studies (mainly onco-hematology), while early phase studies (phase I and II) account for the 45% of the total number (compared to 43% of the last year). Data described in this annual Report also demonstrate that the most represented therapeutic areas are oncology (35%), followed by cardiovascular (8.6%), nervous system diseases (6.9%) and blood and lymphatic system (5.1%). The 70 % of the active substances have a chemistry synthesis's origin while the remaining 30% come from organic or biotechnology production. Considering the studies objectives, the majority of them regards safety and efficacy (538 and 522 CTs, respectively), followed by therapeutic use (phase IV or protocols of access to medicines and security follow-up: 338 CTs) and pharmacokinetics (259 CTs). It is also remarkable that, with a market share equal to 17.2% of the pharmacological research compared to the European Union, Italy is in line with the previous years. Source: http://www.agenziafarmaco.gov.it/it/content/rapporto-sulla-sperimentazione-clinica-dei-medicinali-italia
The fourth issue of the newsletter pertaining to DEEP-2 clinical trial, one of the three studies at the bottom of the DEEP Project (DEferiprone Evaluation in Paediatrics) was published on January 7th, 2015. This Newsletter highlights the main progresses achieved in the study advancement since July 2014 and provides an overview on the status of the participant experimental sites up-to-date as of the 31th of December 2014, from different points of view (regulatory, monitoring, recruitment). It also includes the Frequently Asked Questions (FAQs) emerged, that are all available on the DEEP website. See the newsletter for more data.
In October 2014, the European Medicines Agency (EMA) Board adopted the wording of the Agency’s new policy intended to further increase the availability of clinical trials data for medicinal products authorised in the EU: European Medicines Agency policy on publication of clinical data for medicinal products for human use Q&A on the European Medicines Agency policy on publication of clinical data for medicinal products for human use This new policy aims to ensure that all clinical study reports supporting an application for a centralised marketing authorisation are systematically made public once the regulatory procedure for authorisation is concluded. By enabling the general public to access this data, it is hoped that these measures will contribute to increasing citizens' understanding and confidence in the EU authorisation system for medicines. This is the result of an extensive consultation phase launched in June 2013 when the Agency released the draft policy for a three-month public consultation. For more information, please visit the EMA website.
The core strategy of the NEOMERO Project includes the combination of two clinical trials: Neomero1 (an open-label, randomised, multicenter, comparator-controlled study to evaluate the PK, efficacy and safety of meropenem as compared with standard antibiotic therapy in neonates and infants aged < 3 months treated in neonatal intensive care units (NICU) for late onset sepsis (LOS) defined as sepsis appearing after 72 hrs from birth) and NeoMero2 (an open label, multicenter, observational study to evaluate the PK and safety of meropenem in neonates and infants aged < 3 months with bacterial meningitis admitted to NICUs). As of December 27th, 2013, the trial status is the following: 166 patients have been randomised in NM1 study and 25 patients have been included in NM2 study.