ADVL08N1: A Pharmacokinetic Participation Questionnaire Study
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
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.
To use a simple 2 page survey to gather preliminary information on why parents/children
agree to participate in Phase I Studies do or do not agree to participate in the voluntary
pharmacokinetic (PK) portion of those studies.
Subjects (greater than or equal to 18 years old) or parents/guardians of subjects who are
minors who consented to Phase I studies with optional PK sampling with the previous 4 weeks.
Consent for the primary Phase I treatment protocol must be active (not withdrawn).
No limit on the number of prior Phase I studies in which the subject or subject's child
Subjects may only participate in this study once.
The individual who provided consent to the treatment study that included optional PK
sampling will complete a short questionnaire.
Subjects (n=50) from a convenience sample will complete and return the questionnaire.
Reasons for participating or agreeing to participate will be tabulated. Correlations between
answers and subject demographics, time required by PK, need for additional IV will be
Subjects will meet off study criteria when the questionnaire is returned, lost to follow up,
or consent for data submission to this or the primary treatment protocol is withdrawn.
The total accrual is 50 subjects. Accrual ceiling at the POB, NCI is 25 subjects.
Time Perspective: Prospective
United States: Federal Government
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