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. […]
On October 14th-15th, 2016 the city of Tirana (Albania) will host the 16th National Conference of Paediatrics promoted by the Albanian Paediatric Society (APS) with the participation of international prominent personalities in the field of paediatrics. The Conference is intended to emphasise the importance of the Pediatrics and subspecialties on the Health Care System and to face problems concerning doctors who work every day with children. We have discussed about the conference with Prof. Dr. Anila Godo, President of the Albanian Paediatric Society (APS) and with Prof. Adriana Ceci and Donato Bonifazi who will take part in the international event and asked them for some anticipation. […]
On November 12th, 2015 the Italian Association Contract Reseach Organisation (AICRO) will organise in Milan (Hotel Principe di Savoia) the event entitled Le “sfumature” della ricerca clinica in Italia, an entirely day dedicated to the clinical research that will address issues on the evolving of new ways of managing clinical trials in Europe (and specifically in Italy), including the synergies between AICRO and clinical trial centres. […]
The article “Clinical Trial Application in Europe: What Will Change with the New Regulation?” is now available at the Science and Engineering Ethics journal
On June, 3rd 2015 the article entitled “Clinical Trial Application in Europe: What Will Change with the New Regulation?” has been published on theScience and Engineering Ethics journal. The authors (Viviana Giannuzzi, Annagrazia Altavilla, Lucia Ruggieri and Adriana Ceci), address the challenges derived from the Clinical Trial Regulation recently issued by the European Commission that is changing the European legal framework surrounding clinical trials on medicinal products for human use. In this work, the European rules governing the Clinical Trial Application have been analysed, also dealing with special issues, such as paediatric research and trials involving non European countries. The authors underline the need to overcome the existing lack of harmonization of clinical trial procedures among countries, an aspect which is gaining more and more importance, due to the increasing number of multicentre and multinational studies. You can get access to the free abstract and to the publication by clicking on the following link.
The “Rare Disease Day” campaign has reached its 8th edition this year, on February 28th, bringing once more, to public attention, the topic of rare diseases as a subject of medical, political and institutional concern. The initiative was founded by EURORDIS and its Council of National Alliances in 2008, triggering, ever since, a series of related events all around the globe, fastly turning from an European campaign to a world-renowned advocacy event that stands for dissolving ignorance and empowering collaboration for the better understanding and treatment of rare diseases. “Rare Disease Day” has notably contributed to the advancement of national plans and policies for rare diseases in a number of countries. This year’s theme, “Living with a rare disease”, makes reference to and tries to bring to light and to public appreciation the efforts made by rare disease patients, by their families and friends to cope. The slogan Day-by-day, hand-in-hand of the Official Rare Disease Day 2015 Video evokes the solidarity between families, patient organisations and communities. CVBF welcomes this initiatives by becoming a friend of Rare Disease Day and showing its support on its official website. We proudly join the “Rare Disease Day” manifesto and dedicate all our efforts to improve the healthcare system, also to search, test and provide better treatment and a better handling of these rare diseases.
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
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.
CVBF, partner of the Gianni Benzi Pharmacological Research Foundation and the paediatric clinical research activities carried out through its DEEP project have been the object of an article published on “Il sole 24 ore – Eventi Sud” on 20th October with the title “CVBF – Innovazione nella ricerca clinica pediatrica” (CVBF – Innovation in paediatric clinical research). Donato Bonifazi, CEO of CVBF and Project Manager of one of CVBF main paediatric projects, DEEP (DEferiprone Evaluation in Paediatrics) has highlighted its value: “The DEEP project will also lead to the collection of information intended for regulatory purposes and may thus provide an important contribution to paediatric research in giving the opportunity to many children in the world to have a new syrup specifically tested for them “. […]
CVBF and the paediatric clinical research activities carried out through its DEEP project have been the object of an article published on "Il sole 24 ore - Eventi Sud" on October 20th with the title "CVBF - Innovazione nella ricerca clinica pediatrica" (CVBF - Innovation in paediatric clinical research). http://issuu.com/comunicazionecvbf/docs/02_cvbf3/0