Accrual ceiling at the POB, NCI is 25 subjects. 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is returned, lost to follow up, or consent for data submission to this or the primary treatment protocol is withdrawn.

Correlations between answers and subject demographics, time required by PK, need for additional IV will be sought. Reasons for participating or agreeing to participate will be tabulated. Subjects (n=50) from a convenience sample will complete and return the questionnaire. The individual who provided consent to the treatment study that included optional PK sampling will complete a short questionnaire.

Subjects may only participate in this study once. No limit on the number of prior Phase I studies in which the subject or subject's child participated. 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optional PK sampling with the previous 4 weeks.Ĭonsent for the primary Phase I treatment protocol must be active (not withdrawn). 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. Understanding families' reasons may reveal barriers to participation that could be overcome, leading to increased participation rates in optional PK sampling. There are no recent data on why families do or do not agree to participate in optional PK studies. The rate of participation in optional PK studies on COG Phase I Consortium Studies has been 60-70%. 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. Pharmacokinetic studies provide critical information about the disposition of anticancer drugs in children. Relapsed Solid Tumors Relapsed Leukemia Relapsed Brain Tumors

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

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.

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

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.

Often, patients or parents of children in drug studies choose not to participate in optional PK studies that are part of the study protocol.

These studies provide critical information about new drugs. 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.Why Should I Register and Submit Results?.

What does pk stand for