PLoS ONE (Jan 2013)

Parents' agendas in paediatric clinical trial recruitment are different from researchers' and often remain unvoiced: a qualitative study.

  • Kerry Woolfall,
  • Valerie Shilling,
  • Helen Hickey,
  • Rosalind L Smyth,
  • Emma Sowden,
  • Paula R Williamson,
  • Bridget Young

DOI
https://doi.org/10.1371/journal.pone.0067352
Journal volume & issue
Vol. 8, no. 7
p. e67352

Abstract

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Ensuring parents make an informed decision about their child's participation in a clinical trial is a challenge for practitioners as a parent's comprehension of a trial may differ from that intended by the practitioners responsible for recruitment. We explored what issues parents consider important when making a decision about participation in a paediatric clinical trial and their comprehension of these issues to inform future recruitment practice. This qualitative interview and observational study examined recruitment in four placebo-controlled, double-blind randomised clinical trials of medicines for children. Audio-recorded trial recruitment discussions between practitioners and parents (N = 41) were matched with semi-structured interviews with parents (N = 41). When making a decision about trial entry parents considered clinical benefit, child safety, practicalities of participation, research for the common good, access to medication and randomisation. Within these prioritised issues parents had specific misunderstandings, which had the potential to influence their decisions. While parents had many questions and concerns about trial participation which influenced their decision-making, they rarely voiced these during discussions about the trials with practitioners. Those involved in the recruitment of children to clinical trials need to be aware of parents' priorities and the sorts of misunderstandings that can arise with parents. Providing trial information that is tailored to what parents consider important in making a decision about a clinical trial may improve recruitment practice and ultimately benefit evidence-based paediatric medicine.