Even before the pandemic, non-profit clinical trials, i.e. not directly promoted by pharmaceutical companies but by public or non-profit research bodies, had dropped: by more than 4% in five years, between 2015 and 2019. With the arrival of Covid-19, then, all clinical trials – profit and non-profit – have suffered a slowdown: already in the first half of 2020 alone they had been reduced by a third. A trend that weighs heavily on progress in the oncology field, since as many as 40% of all trials concern tumors (just think that in 2019 268 were started). This is the picture presented today by the Ficog (Federation of Italian Cooperative Oncology Groups) which, in the course of a meeting that is currently being held in Milan, launches the campaign “Do you know how important it is?” to sensitize citizens and institutions on the importance of independent research.
Countryside
The initiative involves the creation of a booklet (distributed in the main oncology divisions and downloadable online) and a survey aimed at both patients and the general population. From the point of view of communication, the campaign will launch an advertising spot, the distribution of brochures, will involve traditional media and social networks. “Italian research has made important contributions to world oncology and many of our studies have changed clinical practice for the treatment of numerous tumors”, he explains to Oncoline. Carmine PintoPresident of Ficog (which brings together 17 Italian oncological cooperative groups with the aim of promoting all-round non-profit clinical research): “With the diminishing impact of the pandemic on the national health system, both profit and independent studies have restarted and the time has come to relaunch research in our country. This is not a campaign in which we seek funds, but with which we want to inform institutions and the population of how important research is. The message addressed to patients is twofold: to clarify how much it is important to be able to participate in a clinical trial both for its quality of life and for the people who will face the same disease in the future. In the US, the “advertising” on clinical trials is even seen on buses: information.
The video collects the message of the representatives of cancer groups, who ask that the right weight be given to science. Italian research has made important contributions to world oncology and many of our studies have changed clinical practice for the treatment of numerous cancers. “The campaign is the only one of its kind: it is the first time that such a thing has been done at a European level,” Pinto emphasizes.
Advances that have increased survival
Since 2000, research has made it possible to significantly increase survival. The data say so: in 2002/04 the percentage of patients alive at 5 years was, on average, 55% for men and 61% for women. In 2018, on the other hand, we went to 59.4% and 65%, respectively. “Clinical research is one of the main drivers of this positive evolution”, he continues Saverio CinieriNational President of the Italian Association of Medical Oncology (Aiom): “The independent one, in particular, however, needs to be strengthened and reorganized, also in consideration of the fact that the delays accumulated due to the pandemic are leading to an increase in stage diagnoses more advanced “.
The obstacles to research in Italy
But what are the main obstacles to research in Italy? As Pinto explains, the question must be considered from three points of view. V A first problem concerns the procedures for activating studies, both for profit and non-profit, which depend on administrative aspects, such as the presentation of protocols and the activation of ethics committees. “The European regulation 536/2014 on clinical trials should allow the resolution of many obstacles – says President Ficog – but its application is still fragmented and there are still many difficulties. We are working hard to simplify all processes”. Then there is the question of recognizing the figure of the data manager (or Clinical Study Coordinator), essential for setting up a clinical study: “Outside the IRCCS, these professional figures are often precarious. The question of insecurity also concerns the researchers in public bodies, who often wait more than 5 years to be stabilized and eventually choose a career in the company “, Pinto points out. The third element, connected to the previous two, calls into question public economic resources and the lack of a single national coordination: “A single organization that manages the research, supported by a national program dedicated, in our case, to oncology . Today not only are the resources limited, but they are divided into interventions that are not coordinated with each other “.
The watchwords are therefore to facilitate and coordinate, as he concludes Evaristo Maiello, President-elect Ficog: “It is necessary to promote clinical research from a planning, management and administrative point of view. To do this, we need to start raising awareness not only among patients but also stakeholders and the population. And this is the primary objective we want to achieve with our campaign “.