When biological complexity demands more than better trial designs

The increasing complexity of precision medicine has highlighted the limitations of traditional randomized clinical trials (RCTs) when applied to highly stratified populations and biologically heterogeneous diseases. In this context, master protocols represent an evolution towards integrated experimental infrastructures, capable of simultaneously evaluating multiple interventions or molecular subgroups within a single methodological framework.

Optimising combination therapy for paediatric, adolescent and young adult patients with non-rhabdomyosarcoma soft tissue sarcomas: The OCTOPUS platform trial

Few innovative treatments were developed for patients with non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) in the past decades. The paper describes the OCTOPUS project (Optimising Combination Therapy fOr Paediatric, adolescent and yoUng adult patients with non-rhabdomyosarcoma soft tissue Sarcomas), a master protocol and includes an adaptive platform trial comprising different sub-trials, a real-world data registry, translational studies, and overarching study questions assessing local therapy issues and patient reported outcome measures (PROMs).

The evolution of cinematic language in portraying cancer

Drawing inspiration from the sitcom Ho Preso un Granchio created by the young patients of the Youth Project at the Istituto Nazionale dei Tumori in Milan, this paper discusses how the depiction of cancer in film and television has changed over the years: specifically, how in 50 years society has gone from being unable to even pronounce the word “cancer” to being able to laugh about it, much like they did, telling their own stories with self-irony and even black humor.

Ethics in the evaluation of the quality of scientific research: An AIOM-TJ roundtable

The current scientific ecosystem is characterized by a systemic crisis driven by the Publish or Perish culture and an exponential growth in publication volumes that outpaces the number of active researchers. Here, we highlight the limitations of traditional bibliometric indicators, such as the Impact Factor and H-index, which have become targets for manipulation and enable inflationary business models, including the proliferation of special issues.

Ten tips to reduce gaps in daily oncology practice

The daily practice of oncology in Italy is increasingly strained, with bureaucratic rigidity making routine clinical work progressively more difficult. A panel of clinical oncologists, reunited in the DonnaRosa Group, an emerging model of community-based collaboration, where clinicians share real-world challenges and develop actionable strategies, debate the points with the aim of producing some tips to close the gap in clinical practice.

Two years after the reform of Italian Ethics Committees: Time for reflection

The recent reform of Italian Ethics Committees (ECs), formalized between 2022 and 2023, aimed to streamline ethical oversight in clinical research by transitioning from a fragmented local system to a coordinated national framework. The new structure includes 40 Territorial Ethics Committees (CETs) and three National Committees (CENs), under the supervision of the National Coordination Centre (CCNCE). While the reform aligned Italy with European Regulation (EU) No 536/2014, significant implementation gaps remain.