A Pharmacokinetic Participation Questionnaire Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Correlation between study questionnaire answers and the need for additional IV
研究概览
简要总结
RATIONALE: Gathering information about why patients or their guardians agree or decline to participate in the optional pharmacokinetic portion of a phase I treatment study may help doctors plan clinical trials in the future.
PURPOSE: This clinical trial is looking at decision making about participating in pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.
详细描述
OBJECTIVES:
- To use a simple 2-page survey to gather preliminary information on why patients or parents/guardians (if patient is a minor) do or do not agree to participate in the optional pharmacokinetic portion of a phase I treatment study while consenting to participate in the phase I treatment study.
OUTLINE: This is a multicenter study.
Patients or parents/guardians (if patient is a minor) complete a short questionnaire on the reasons for agreeing/declining to participation in the optional pharmacokinetic sampling component of the phase I clinical trial.
Patient demographics and other relevant information are collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
Correlation between study questionnaire answers and the need for additional IV
时间窗: Length of study
Correlation between study questionnaire answers and patient demographics
时间窗: Length of study
Correlation between study questionnaire answers and time required by pharmacokinetic sampling
时间窗: Length of study
次要结局
未报告次要终点