Bioikòs Farma in collaboration with Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), CME Provider n. 1053, is pleased to present the thirteenth edition of the course for clinical monitors, which since this year, provides also with Italian CME credits. The course is aimed at young graduates interested in learning about this job profile and professionals who already work in public research institutions such as IRCCS, hospitals, polyclinics or scientific sssociations as researchers, data managers, study coordinator and willing to learn more about the clinical research and the figure of the monitor. The clinical monitor, in fact, is a strategic figure in the context of the clinical trial as he plays a checking role of the validity of data obtained from clinical trials. The course consists of 40-hour lesson (face to face lessons and interactive workgroups) and applies for 50 Italian CME credits. Deadline for applications: 27/02/2015 Please see the following references (ITA) for more information: course brochure course program and calendar registration form For further information, please contact Silvia Smaia at [email protected] o visit the dedicated website.
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.
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
The first newsletter of the DEEP-2 clinical trial of the DEEP Project, performing an efficacy/safety test to compare deferiprone with deferasirox, was published on March 31st, 2014. It contains the latest recruitment data as well as the FAQ in order to address some issues raised by the investigators. […]
The first newsletter of the DEEP-1 pharmacokinetic study of the DEEP project was published on December 23rd, 2013. Among other results, the first milestone of the experimental phase, that is the recruitment and study completion of the first 18 patients, has been reached. […]
The first newsletter of the DEEP-3 observational study of the DEEP Project, evaluating the long-term safety of deferiprone in children, was published on October 23rd, 2013. It contains the latest recruitment data as well as useful hints for the data collection. […]