What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials

Toward a Patient-centered Early Drug Development in Oncology: What Unmet Need for the Patients? A Focus on the Social Determinants of Health in Phase 1 Clinical Trials

An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.

The study focuses on defining the problem of geographical accessibility of patients to the Phase 1 facility of the European Institute of Oncology, based on an anonymized extraction of data from the enrolled patient database, to assess national territorial disparities in access to innovative experimental therapies, in relation to various socioeconomic determinants. Finally, information on relevant psychological factors for participation in clinical trials will also be collected.

Inclusion Criteria :

• Patient with a histological or cytological diagnosis of solid or hematological tumor.
• Age ≥ 18 years.
• Patient enrolled in a phase 1 and early phase 2 study at our institution.
• The patient has received at least 1 administration of the experimental drug under study in the early phase trial.

Exclusion Criteria :

- Patients treated in phase 1 trials at other institutions, even if referred to our division or receiving standard therapies at IEO but outside of clinical trials, are not included.