(Finance) – The event was held in Rome, at the Centro Studi Americani “Decentralized clinical trials: between ethics and development opportunities” promoted by The Bridge Foundation with the patronage of‘Higher Institute of Health and Agenas – National Agency for Regional Health Services.
During the day, the results of the multidisciplinary working group were presented which, starting from the study of European and international best practices, conducted an analysis of the decentralized forms of clinical trials, both from a regulatory and logistical point of view – trying to understand the opportunities for the country system and for citizenship, as well as obstacles and feasibility – and, above all, from an ethical point of view, taking due account of the simplification of procedures that occurred during the pandemic emergency.
Furthermore, the idea was relaunched, accepted by the parliamentarians present, of setting up a parliamentary intergroup on research and clinical trials.
The pandemic has made it possible to see how, despite the restrictions integrated into daily life, it has been possible to guarantee continuity (albeit at times with obvious difficulties) both in the provision of care and services and in the supply of medicines and in the treatment of patients enrolled in trials. It is therefore useful to understand how procedures implemented in an emergency – or already in force in other countries – can be made more structural to favor greater fluidity in the field of clinical research.
THE Decentralized Clinical Trials (DCT) from this point of view, they represent an important turning point because they include the use of digital technologies, remote connections with the patient, dispensing and administration of therapies at home or in contexts other than the research centre. The result of this analysis then merged into a document that takes stock of the possible feasibility guidelines of decentralized protocols in our country, identifying critical issues, opportunities and outlining an initial proposal for guidelines.
“We have decided to address the issue of decentralized forms of clinical trials – he said Rosaria Iardino, president of The Bridge Foundation – since it is an approach that is already widely used internationally. We believe it represents a great opportunity for our country, which however needs a system of rules that must be defined quickly if we don’t want to fall behind compared to other realities. We are therefore turning to politics so that they can grasp this stimulus and develop this new method of clinical research in Italy”.
The DCT working group – The day saw a succession of speeches, first of all by members of the DCT working group. Chiara Crepaldi, senior researcher at The Bridge Foundation Study Center, focused in particular on the European scenario on the subject of DCT. In the round table entitled “The innovative procedures introduced during the Covid emergency – potential and critical issues emerging from the point of view of the researcher and the health system”, moderated by Carlo Maria Petrini of the Istituto Superiore di Sanità, Giuseppe Lauria Pinter discussed of the IRCCS “Carlo Besta” Neurological Institute, Francesco Perrone, Pascale Cancer Institute of Naples and president-elect of the Italian Association of Medical Oncology (AIOM) and Giuliano Rizzardini of the Fatebenefratelli Sacco, of Milan. Eva Pesaro, vice president of UNIAMO FIMR Onlus – Italian Federation of Rare Diseases, analyzed the potential and risks from the patient’s point of view. Damiano Fuschi of the University of Milan illustrated the potential and risks in terms of privacy and the new frontiers of the Blockchain. Monsignor Andrea Manto, head of the Office for Health Pastoral Care and of the Center for the Pastoral Care of the Family of the Diocese of Rome – president of the Ut Vitam Habeant Foundation, analyzed the theme from an ethical point of view, highlighting some cornerstones that cannot be lost sight of, including a careful assessment of the balance between risks and benefits and the desirability of including underrepresented populations in trials. Giacomo Lucchini, of Bcube, explored the aspects related to logistics and delivery in the healthcare field, while Anna Maria Porrini, medical director of Roche Italia, illustrated the point of view of an industrial promoter on the subject of clinical trials. Francesco Gabbrielli, director of the National Center for Telemedicine and New Welfare Technologies of the Istituto Superiore di Sanità, also spoke, illustrating the Report “DCT: new approach to clinical trials to facilitate patients and speed up research”. Subsequently Gualberto Gussoni, scientific coordinator of the FADOI Foundation Study Center, launched some points of reflection, starting with the report promoted by the Smith Kline Foundation and FADOI “Implementation of Decentralized Clinical Studies in Italy: why and how?”. Both reports represented important input documents for the working group coordinated by The Bridge Foundation.
The political point of view The second part of the day was dedicated to discussions with institutional and political representatives, who welcomed the proposal that emerged from the Working Group to set up a parliamentary intergroup on research and clinical trials. “We have a great responsibility to put in place all the necessary conditions for a successful research strategy. In this sense, it also becomes important to create a parliamentary intergroup on clinical trials, in order to break and overcome all those barriers that today stop the The issuing of implementing decrees and the application of the European regulation – declared Fabrizio Sala, deputy of Forza Italia and member of the VI Permanent Finance Commission – Investing in clinical research means, in fact, investing in great opportunities for our country. on the one hand, clearly, for the resulting advantages in terms of new therapies for patients, indispensable for saving lives, and on the other, also for the significant economic leverage effect, for example, in terms of scientific competitiveness”.
“There are some questions that are still open and cannot be postponed further, such as that relating to ethics committees and the application of the indications that come to us from Europe. Through an intergroup – he declared Beatrice Lorenzin, Senator of the Democratic Party – we will be able to work on the implementing decrees and bring the reasons of the scientific and research world into the political debate”.
The Lega senator also spoke Maria Cristina Cantù, vice president of the 10th Permanent Commission on Hygiene and Health of the Senatewhich highlighted “the need to build a European system that provides for the financing of subjects with qualified interests to protect users, to favor objective checks of the effective perception of well-being deriving from innovation and advanced therapies, so as to support the institutions in the evaluation of the outcomes and uses in a position of impartiality and autonomy with respect to the sources of financing from the pharmaceutical companies.It is necessary to develop – he added – with highly specialized skills and knowledge the institutional capacity for interaction at a European level to direct the sources of funding of translational research in the research pathways most positive for patient health”.
In the end, Marco Osnatodeputy of the Brothers of Italy and president of the VI Permanent Finance Commission, applauded the initiative of The Bridge Foundation, assuring his support for the proposals that emerged from the discussion which will be able to guarantee more and more opportunities for treatment for citizens and greater development of the clinical research in Italy.