NCT06326242

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
OTHER	Solid Tumor	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 anonymized data extraction from the enrolled patient database, to evaluate national territorial disparities in access to innovative experimental therapies, in relation to various socioeconomic determinants. Finally, relevant information on psychological factors for participation in clinical trials will also be collected.

Timeline

• Start date: 2023-03-27
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

1 site across 1 country: Italy