FIMMG project made possible thanks to a donation of 1.5 million Euros from Merck & Co. through its subsidiary MSD Italia. For the first time in Italy, a training project dedicated to selecting researchers specialized in drug testing and management from among family doctors
by Marcello Longo – March 9, 2015 – AboutPharma
To train general practitioners on the field of clinical trials and in particular on the management of drugs before and after they are placed on the market. It is the goal of the first Italian School of Research in General Medicine presented today in Rome by the Italian Federation of Family Doctors (Fimmg) and made with the unconditional support of Msd Italy. The project will involve 400 white coats in the area for the next two years and will give life to the "Fimmg Clinical Research Group". The mission of the selected family doctors will be to develop new clinical models and participate in studies on the efficacy and safety of drugs based on real patient experience.
"The school - explains the general secretary of Fimmg, Giacomo Milillo – serves to introduce a doctor specially trained in research into the territory, a figure capable of assembling the large numbers that distinguish General Medicine and of planning a research, of elaborating and interpreting the results obtained”. According to Milillo, the figure of the doctor-researcher should enter the territorial functional aggregations (Aft) and be envisaged in the General Medicine Convention, which has been discussed again in recent days for the resumption of negotiations. "Let's hope that the Regions will accept it", hopes the Fimmg secretary.
The need for an ad hoc training course arises from the lack of structured information and data from general medicine. “The patient belonging to territorial medicine – he claims Walter Marrocco, Fimmg scientific director – has clinical and treatment characteristics that are very different from those of the patients selected in clinical trials conducted in healthcare facilities. Too often it is not possible to translate into daily clinical practice what are the results of scientific research and it is even more difficult to pursue the personalization of treatment, as instead is required of the general practitioner". The presence of concomitant therapies and the "frequent comorbidity" - adds Marrocco - are "common characteristics in the patients observed by the general practitioner, while the studies conducted in the pre-registration phases lead, through the identification of particularly analytical inclusion / exclusion criteria, to select a population that is often very different from that of the real world".
The need is to evaluate the use of drugs, the methods of prescribing and dispensing them, the relative costs, the therapeutic appropriateness, in the light of the experience of use of the "real patient". "It is a transition to 'real medicine' because the large numbers, those of the 'real population', are in the offices of family doctors", he comments Raffaele Calabro, deputy of the Social Affairs Commission of the Chamber of Deputies. The initiative is also liked by Sergio Pecorelli, president of the Italian Medicines Agency (Aifa), who underlines the value of collaboration with doctors “not only as responsible for prescribing choices, but also as precious sentinels of the efficacy and safety of a drug in real life.
The project makes use of a contribution of one and a half million euros provided by Merck & Co. through the Italian subsidiary Msd. “Research is one of the primary activities carried out by our company – he says Pierluigi Antonelli, president and managing director of Msd Italia - and the support to Fimmg for the creation of the School is an important step in a multi-year path launched by the company to support Italian scientific and professional institutions in the field of independent research and which provides for a solid investment plan in the country. In recent months there have been many partnerships, similar to this one, that we have activated in therapeutic areas where unmet medical needs must be addressed with a sense of urgency and responsibility".
The Fimmg Research School is already operational: in recent days the first distance learning course (Fad) has started, preparatory to a three-day residential course at the end of which the participants will gradually be included in the group of researchers. There are still 13 residential courses for 30 participants in which family doctors with more than five years of experience under the agreement and at least 800 patients can participate.
The Scientific Committee of the School includes Marrocco, Milillo and Pecorelli, Lorenzo Maria Donini, Maio Eandi, Massimo Fini, Gianfranco Gensini, Walter Ricciardi and Francesco Rossi. Among the teachers, Paolo Siviero, Antonietta Martelli, Stefano Bonassi, Maria Consuelo Cicalese, Andrea Pizzini and Paolo Misericordia.
Related news:
Merck uses legal threats in Italy to counter negative opinion on Zetia and Vytorin
Hippocratic oath with sponsors doctors rebel: a sacrilege
Agreement on mobility in Merck Sharp & Dohme: redundancies are down, incentives to leave. 206 redundancies - all scientific representatives and employees in support functions -, 152 belong to the primary care area, the rest to the sales area and headquarters staff
MERCK CLOSES IN PAVIA IN 2014: 400 workers risk being fired
