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临床试验/NCT00923468
NCT00923468已完成不适用

ADVL08N1: A Pharmacokinetic Participation Questionnaire Study

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1

研究概览

简要总结

Background:

  • A pharmacokinetic (PK) study of a new drug involves taking several blood samples over a period of time from study participants to determine how the body handles the substance. These studies provide critical information about new drugs.
  • Often, patients or parents of children in drug studies choose not to participate in optional PK studies that are part of the study protocol.
  • A better understanding of why patients or families do or do not agree to participate in PK studies may help researchers make it easier for people to participate in them.

Objectives:

  • To learn why some people do or do not agree to participate in PK blood sampling studies.

Eligibility:

  • Patients 18 years of age and older and parents or guardians of children who are participating in a study of a drug that includes the option of participating in PK sampling.

Design:

  • Participants fill out a 2-page survey asking about why they did or did not participate in the study's PK sampling.

详细描述

Background:

Pharmacokinetic studies provide critical information about the disposition of anticancer drugs in children. However, participation of children in the pharmacokinetic portion of phase I studies is optional when there is not prospect of direct benefit to the child.

The rate of participation in optional PK studies on COG Phase I Consortium Studies has been 60-70%.

There are no recent data on why families do or do not agree to participate in optional PK studies. Understanding families' reasons may reveal barriers to participation that could be overcome, leading to increased participation rates in optional PK sampling.

Objectives:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (1)

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