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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO).
研究概览
简要总结
An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO).
时间窗: 1 year
The primary endpoint is estimating the geographical distance from the enrolled patients' residences to the European Institute of Oncology (IEO), evaluating patients from the Lombardy region versus those from other regions with an assessment by geographical cluster: north, central, south, and islands, in order to define any preferential trajectories or recurring patterns.
次要结局
- The protocol prescriptions in relation to socioeconomic and geographical determinants.(1 year)
- The characterization of enrolled patients involves assessing their participation in clinical trials(1 year)
- The characterization of enrolled patients based on therapeutic compliance.(1 year)