Abstract
Methods Randomised clinical trials of any health care intervention, conducted between 2006 and 2012 and closed to recruitment, were identified. Recruitment performance was assessed by comparing achieved to planned recruitment. Putative factors affecting recruitment will be tested for association with successful recruitment, defined initially as recruitment to 100% of target in the planned time frame. Five factors were selected from an evidence based list of potential factors affecting recruitment; being an IMP (Investigational medicinal product) vs. non-IMP trial, trial of acute vs. chronic illness, CTU support, pilot or feasibility assessment and logistical burden of the trial as compared to routine care.
Highlights
Recruitment of children to randomised clinical trials is perceived to be difficult, empirical evidence is lacking
We have undertaken a review of recruitment to paediatric trials in the National Institute of Health Research (NIHR) portfolio to understand the current situation and investigate factors that influence recruitment
Recruitment performance was assessed by comparing achieved to planned recruitment
Summary
Recruitment of children to randomised clinical trials is perceived to be difficult, empirical evidence is lacking.
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