Clinical research, how to keep safe distances between doctors and industry

Clinical research, how to keep safe distances between doctors and industry

Oncologists and hematologists will compose two working groups to support the Technical Scientific Commission (CTS) of the Italian Medicines Agency (Aifa). This was announced by Nicola Magrini, director general of the Italian Medicines Agency, during the special session entitled "AIOM meets AIFA. Modern Oncology: a slalom between rules and expectations", which took place on Sunday 2 October in scope of the AIOM Congress. A collaboration, that between the Agency and specialists, which goes in the direction of the enhancement of clinical research, a fundamental element for the care of patients and in order to guarantee a better health service. For this reason, according to Magrini, it cannot be left in the hands of industry alone. All the more so after the last two years, in which Covid has made it clear how important it is to build and finance networks and platforms to conduct clinical trials that compare therapies that are of greatest interest to the health service and to patients.

The issue of clinical research brings with it that of conflicts of interest, which according to the director of Aifa can be governed in transparency, with the necessary progressiveness, paying more attention to the few major conflicts, and separating the institutional ones from the individual ones, which go verified on a case-by-case basis. As well as maintaining and periodically evaluating the relationship between profit and non-profit research. How? Magrini has put three concrete proposals on the plate. First to allocate more funds for independent research: 100 million per year for five years. Then consider the possibility that the national health service contributes to support the randomized clinical trials, for example by paying for the arm represented by the standard treatment. This would have important implications for supporting clinical research and reducing research and development costs. Third: establish a monitoring of the phase 1 studies conducted in Italy.

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"In recent years we have had phase 2 studies that have produced apparently extraordinary results but which were later denied by those of phase 3. But luckily for us we have a fundamental tool that must guide us in our choices: guidelines. Production and the updating of these documents is the fulcrum of the activity of our Scientific Society. AIOM in the medium term must become as autonomous and independent as possible in the methodological field in the production of the Lines ", underlined during the session the president of the AIOM Foundation, Giordano Beretta. "The latter are increasingly important also from a medico-legal point of view, after the Gelli law of 2017. Within the national guidelines system, as many as 40% are produced by AIOM which is thus the first national scientific society" .

It was then the turn of Rosanna D'Antona, president of Europa Donna Italia, who gave a speech on innovation and access to care. "As patient representatives we want to be the 'bookmark' of your scientific volumes for clinicians and institutions - underlined D'Antona -. We do not pretend to be at the center of the dialogue between specialists and health institutions but we must be listened to. We also ask for contribute to the work of the committees that deliberate on medicines intended for patients ". "Communication with patients also plays an important role - concluded Saverio Cinieri -. As Director Magrini rightly pointed out, we must no longer call them 'trials' but 'clinical studies'. In this way too we can promote clinical research in our country. . Finally, we welcome the creation of the two subgroups of AIFA's CTS and we are ready to give our contribution ".



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