Reasons for participation in optional pharmacokinetic studies in children with cancer: a Children's Oncology Group phase 1 consortium study.
OBJECTIVE
Pharmacokinetic (PK) studies provide critical information about the disposition of anticancer drugs in children. In the Children's Oncology Group (COG) Phase 1 Consortium, pharmacokinetic studies are usually optional. We surveyed the attitudes towards PK studies among subjects in phase 1 trials at COG institutions.


METHODS
Subjects were eligible if they participated in a phase 1 anticancer drug study with optional PK studies within the 4 weeks, regardless of whether they agreed to participate in the PK studies. Staff provided demographics; subjects/parents completed a questionnaire.


RESULTS
Fifty eligible subjects enrolled. Thirty-six (72%) of the 50 eligible subjects consented to participate in PK studies; 14 (25%) declined. The most common reasons for participating were "the results might help researchers learn more about the drug" and "results from the pharmacokinetic studies might help other children." The most common reasons for not participating were "having the samples drawn would mean spending extra time in the hospital," and "my child might have needed a separate IV catheter in order to participate."


CONCLUSIONS
The majority of subjects identified altruistic motives for participation in PK studies. Subjects who did not participate in PK studies identified extra time and need for an extra IV as important concerns. Simple interventions like sending staff to the subjects' home to draw PK samples or drawing samples from existing catheters could increase the number of subjects who are willing to participate in PK studies.
Berg
Stacey L
SL
Texas Children's Cancer Center, Baylor College of Medicine, Houston, Texas 77030, USA. sberg@txccc.org
Winick
Naomi
N
Ingle
Ashish Mark
AM
Adamson
Peter C
PC
Blaney
Susan M
SM
D000293:Adolescent; D000328:Adult; D000533:Altruism; D000970:Antineoplastic Agents / Q000493:pharmacokinetics*; D002648:Child; D002675:Child, Preschool; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology* / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D010358:Patient Participation / Q000523:psychology* / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D055815:Young Adult
D000970:Antineoplastic Agents