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Rethinking How to Persuade More Parents From Diverse or Disadvantaged Backgrounds to Enroll Infants in Neonatal Clinical Trials.

Weiss et have reported important findings from their study of determinants of participation in the High-DoseErythropoietinforAsphyxiaandEncephalopathy(HEAL)trial.HEAL 2 isamulticentertrial that enrolled patients with hypoxic ischemic encephalopathy at birth after parental consent. The present study compared 183 of 242 (75.6%) of the HEAL-participant parents with 86 of 145 (59.3%) of HEAL-declined parents to identify factors associated with trial participation. Parents who self-reported as Black, lower income, insured by Medicaid, having less concern about their baby’s condition, and having less trust in medical research were more likely to decline enrollment. Although not surprising, these findings should serve as a call to action. Without adequate representation in trials and in observational studies, such as the HEAL trial and the survey study by Weiss et al, 1 biases will plague otherwise exquisitely designed science by limiting generalizability and applicability of findings to all infants in our care.