IRST Dino Amadori IRCCS

Trials and Clinical Studies

The years 2020-2021 were strongly affected by the pandemic outcomes in terms of patient access to clinical trials, particularly for studies with high interest and also for patients outside the region. For some years now, clinical trials in oncology have been undergoing a complex transformation in their design, to the extent that a large proportion of protocols involve several pathologies (basket trials) and several experimental active ingredients in various settings and with various drug combinations (platform trials).

Most studies provide for a selection of the population to be treated based on molecular characteristics using a centralised reading of the biological material for an increasingly precise personalised therapy. This trend can be verified by the lower number of patients included in the studies compared to previous years with the same number of active clinical trials (very often the molecular characteristic required is expressed in a fraction of less than 10 per cent of patients), is evidenced by a higher number of monitoring visits by the promoters of the trials, and an increase in grants. These latter indicators reveal a steady increase in the complexity of study management.

In 2021, activities continued in Phase 1, which is the first step of the new drug in human trials. Clinical trials, in addition to offering new therapeutic opportunities to patients, provide the Institute with an important financial contribution and considerable savings, thanks to the drug coverage provided by companies.

Since its start, IRST has sought to stimulate and promote scientific collaborations, believing that exchange is fundamental for the development of individual research projects and experiments. At a territorial level, the most important collaboration is with the AUSL of Romagna; at a national level, the dialogue with other IRCCSs, universities, collaborative groups, various hospitals, health authorities, and research bodies, is important. There are numerous collaborations and exchanges with research institutes and universities at an international level. The steady increase in the number of research centres involved in IRST projects is a tangible result of these collaborations. In 2021, there were nine active multi-centre interventional drug clinical trials promoted by IRST with the involvement of 79 growing capacity to network and is, moreover, recognised by the Ministry as a pivotal criterion for the allocation of funding for Current Research.