title: Recruitment of infants with sickle cell anemia to a Phase III trial: data from the BABY HUG study.
abstract: BACKGROUND
  Protocol-eligible subjects may not be candidates for research participation or may decline. To determine factors that affected accrual, we evaluated enrollment in BABY HUG, a multi-center, randomized, placebo-controlled Phase III trial of hydroxyurea (HU) in infants with sickle cell anemia.
  
  
  METHODS
  An anonymized registry of potential subjects served as the primary source of data. Study coordinators considered all infants less than age 18 months with a hemoglobin FS diagnosis on newborn screening. Data included the number of potentially eligible subjects, whether parents were approached, and reasons for participating or declining.
  
  
  RESULTS
  Of 1106 potential participants, 28% were not approached for reasons such as prior poor adherence to clinical care. Interested families expressed willingness to contribute to medical knowledge (51%), hope of being randomized to receive hydroxyurea (51%), and desire for closer clinical care (51%) as reasons for participating. Disease severity or the perception that their child was ill had less impact on willingness to participate (16%). Parents who declined cited fear of research (19%), transportation problems (14%), and the demanding nature of the study (25%). Ultimately, 234 (21%) gave informed consent, with little variability of acceptance rates among sites. Importantly, the number of subjects enrolled correlated with the number of families that were approached. Sites that excluded patients based on clinical/psychosocial biases were not more successful in recruiting than those who approached all eligible subjects.
  
  
  CONCLUSIONS
  Large, demanding clinical trials require an adequate pool of potential participants. Approaching all potentially eligible patients without predetermined biases enhances success in recruitment.
authors.affiliation: St Jude Children's Research Hospital, Memphis, TN, United States. lynn.wynn@stjude.org
authors.forename: Lynn
authors.initials: L
authors.lastname: Wynn
authors.forename: Scott
authors.initials: S
authors.lastname: Miller
authors.forename: Lane
authors.initials: L
authors.lastname: Faughnan
authors.forename: Zhaoyu
authors.initials: Z
authors.lastname: Luo
authors.forename: Ellen
authors.initials: E
authors.lastname: Debenham
authors.forename: Lea
authors.initials: L
authors.lastname: Adix
authors.forename: Billie
authors.initials: B
authors.lastname: Fish
authors.forename: Tally
authors.initials: T
authors.lastname: Hustace
authors.forename: Tracy
authors.initials: T
authors.lastname: Kelly
authors.forename: Marylou
authors.initials: M
authors.lastname: Macdermott
authors.forename: Joan
authors.initials: J
authors.lastname: Marasciulo
authors.forename: Brenda
authors.initials: B
authors.lastname: Martin
authors.forename: Jennifer
authors.initials: J
authors.lastname: McDuffie
authors.forename: Mary
authors.initials: M
authors.lastname: Murphy
authors.forename: Betsy
authors.initials: B
authors.lastname: Rackoff
authors.forename: Caroline
authors.initials: C
authors.lastname: Reed
authors.forename: Phillip
authors.initials: P
authors.lastname: Seaman
authors.forename: Glenda
authors.initials: G
authors.lastname: Thomas
authors.forename: Winfred
authors.initials: W
authors.lastname: Wang
mesh_terms: D000755:Anemia, Sickle Cell / Q000175:diagnosis / Q000188:drug therapy; D000986:Antisickling Agents / Q000627:therapeutic use; D001294:Attitude to Health; D006801:Humans; D006918:Hydroxyurea / Q000627:therapeutic use; D007223:Infant; D007231:Infant, Newborn; D009042:Motivation; D015997:Neonatal Screening; D010290:Parents; D018579:Patient Selection
chemical_list: D000986:Antisickling Agents; D006918:Hydroxyurea
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