title: Parental factors impacting the enrollment of children in cardiac critical care clinical trials.
abstract: Clinical trials are abundant in adult cardiovascular medicine; however, they are rare in pediatric cardiology. Pediatric cardiac trial design may be impacted by the heterogeneous nature of the underlying cardiac defects, as well as by a strong emotional response from parents whose child will undergo a surgical intervention. The purpose of this study was to assess factors that may have an impact on parents considering enrollment of their child in a clinical trial at the time of surgical intervention. A voluntary, self-administered questionnaire (14 questions) was provided to parents of children 16 years of age or younger during the preadmission testing period. Demographic and procedure-related variables were collected for each patient. A total of 119 surveys were analyzed over a 1.5-year period. Only 8% of the parents had their child participate in a clinical trial in the past. Fifty-six percent of the parents preferred that their child's cardiologist or surgeon explain clinical trial details, with 23% preferring the principal investigator and 3% preferring the research coordinator. Fifty percent of the parents were favorably disposed to participate in a clinical trial if the drug or device was currently used by their child's doctor, and 19% were encouraged to participate if the drug or device was approved for use in adults. The majority of parents (64%) preferred to be asked about participating in a trial within 1 month prior to the planned procedure, and 40% preferred to discuss trial details at a remote time in an outpatient location. Sixty-three percent of parents believed that most of the medications currently used in children were already approved by the Food and Drug Administration. Most parents (91%) believed that clinical trials conducted in children will help improve pediatric health care; 74% believed that their child may receive potential benefit from enrolling in a trial. Finally, 43% believed that funding for trials should come from government and health care agencies, as opposed to pharmaceutical companies (24%). This survey reveals the importance of the attending physician and timing in educating parents regarding a cardiac critical care clinical trial. These data may impact the design and successful conduct of future trials.
authors.affiliation: Columbus Children's Heart Center, Columbus Children's Hospital, Columbus, OH 43205, USA. thoffman@chi.osu.edu
authors.forename: T M
authors.initials: TM
authors.lastname: Hoffman
authors.forename: R
authors.initials: R
authors.lastname: Taeed
authors.forename: J P
authors.initials: JP
authors.lastname: Niles
authors.forename: M A
authors.initials: MA
authors.lastname: McMillin
authors.forename: L A
authors.initials: LA
authors.lastname: Perkins
authors.forename: T F
authors.initials: TF
authors.lastname: Feltes
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000523:psychology*; D003422:Critical Care; D005260:Female; D006331:Heart Diseases / Q000628:therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010290:Parents / Q000523:psychology*; D011795:Surveys and Questionnaires