Relapsed Solid Tumors Clinical Trial
Official title:
ADVL08N1: A Pharmacokinetic Participation Questionnaire Study
Verified date | August 31, 2009 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | |
Est. primary completion date | August 31, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
- INCLUSION CRITERIA: - Subjects who consented within the 4 weeks prior to enrollment on this questionnaire study to a Phase 1 study that included optional PK sampling. (If the subject was a minor and a parent or legally authorized representative provided consent, subject for this questionnaire study refers to the parent). The PK questionnaire should be completed within 4 weeks of when the subject consented to the study that included optional PK sampling. (Note: The Phase 1 study need not have been a COG study). - Subjects are eligible regardless of whether they initially agreed to participate in the PK portion and regardless of whether they actually completed the PK sampling (as long as reason for not completing the sampling was not withdrawal of consent). - Subjects must not have withdrawn consent to the study that included optional PK sampling. - Subjects must not have initially agreed to optional PK sampling but then withdrawn consent for sampling prior to completing the questionnaire. - Subjects are eligible regardless of how many phase 1 or other studies they have enrolled in the past. - Each subject may participate only once in the survey. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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