Looking forward to the future, the trends and challenges regarding the increasing utilization of real-world data and single-arm trials in the oncology drug approval pathway by European Medicines Agency (EMA) is very important, especially in the context of personalized medicine that will become the future.

Dr. Francesco Pignatti, Scientific advisor for Oncology in the Human Medicine Division of the European Medicines Agency, is the guest of this TJ Talks episode - led by dr. Luca Moscetti, Adjunct Professor in Oncology at the Residency Program in Oncology at the University of Modena Reggio Emilia - that addresses the relevant question for cancer patients about the EMA’s position on the use of real-world data in drug approvals.

It emerged during the thick TJ Talks that for big changes in the use of real-world data much will also depend on the uncertainty one is willing to accept in a specific situation. Single-arm trial, for example, comes with a lot of uncertainty, mostly about the time related endpoints like survival, then you have to you tend to accept them more where you have high unmet medical needs.

The goal of the scientific community is to focus the efforts on what really matters, trying to be more efficient, cleverer and to design quality criteria that are fit for purpose and that are proportionate to the objectives. Regulators, academics and the sponsors need to facilitate this type of research, maximising the opportunities that come from its data.

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Le parole del prof. Paolo Marchetti restituiscono il quadro complesso dell’oncologia di precisione con il ritmo epico delle grandi imprese di frontiera. E’ lui - Professore Ordinario di Oncologia Medica dell’Università degli Studi di Roma “La Sapienza”, Direttore Scientifico di IDI-IRCCS, Presidente della Fondazione per la Medicina Personalizzata e promotore dello studio clinico Trial Rome - grande esperto dell’oncologia di precisione in Italia, l’ospite di questo episodio di TJ Talks, condotto dal prof. Giancarlo Pruneri.

Un concetto ampio quello dell’oncologia di precisione, basato sullo studio del genoma delle cellule tumorali, per illustrare il quale il prof. Marchetti sottolinea i vantaggi clinici che l’applicazione di questo percorso comporta, senza dimenticare quei fattori perturbanti la possibile risposta a un determinato farmaco: come le interazioni, le modificazioni del microbiota, stili di vita e attività fisica. Un quadro complesso che promuove il confronto tra clinici, biologi molecolari, patologi e genetisti su un numero crescente di dati eterogenei.

E l’intelligenza artificiale? Fondamentale per gestire i dati provenienti da studi clinici a livello europeo, o presenti in piattaforme nazionali; indispensabile per comprendere i potenziali meccanismi di resistenza ai farmaci e per la sintesi delle conoscenze più appropriate e personalizzate per la cura del paziente.

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In this episode of TJ Talks, the guest is Professor Paolo Marchetti, a well-known expert in precision oncology in Italy, Full Professor of Medical Oncology at the University of Rome "La Sapienza", Scientific Director of IDI-IRCCS, President of the Foundation for Personalized Medicine and promoter of the Trial of Rome clinical study.

Precision oncology is a broad concept based on the study of the genome of tumour cells and Prof. Marchetti – interviewed by Prof. Giancarlo Pruneri - highlights the clinical advantages of applying this path, without forgetting the factors that interfere with the possible response to a given drug: such factors include interactions, alterations of the microbiota, lifestyle and physical activity, making the scenario even more complex and fostering comparison among clinicians, molecular biologists, pathologists and geneticists on an ever-increasing number of heterogeneous data.

In precision oncology, the role of artificial intelligence in managing data from clinical trials is essential to understand potential mechanisms of drug resistance and synthesize the most appropriate and personalized knowledge for patient care.

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