Safety in paediatric clinical trials – a 7‐year review

Abstract

About 11% of trials have a moderate or severe ADR. All paediatric clinical trials should have a SMC.

Death, bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trials

“…There is widespread concern that most medicines used in the field of paediatrics are unlicensed or off-label. 2,86 It has been suggested that the pharmaceutical industry has been reluctant to conduct clinical trials of medicines because of the small market for the sale of drugs for babies and children, making investment in expensive research less attractive. Other reasons may include concerns about the ethics of conducting research in children, difficulties with blood sampling and recruiting sufficient numbers.…”

Clinical research in newborn infants: difficulties and specificity

“…In a recent review, Sammons and colleagues evaluated the drug toxicity studying 739 pediatric clinical trials published over 7 years [6]. Seventy one percent of …”

Clinical trials in children

“…There are additional ethical challenges because children lack the capacity to understand the risks involved in trials and depend upon adults to make decisions for them [110]. In a review of 739 paediatric trials from 1996 to 2002, 523 (71%) reported adverse drug reactions, but only 13 (2%) of the trials had safety monitoring committees [4]. Since then, trial governance is becoming more stringent with a requirement for an independent safety monitoring board with paediatric expertise, who can appreciate the uniqueness and unpredictability of responses in children [76,111].…”

“…Since the acknowledgement of children as 'therapeutic or pharmaceutical orphans' in the 1960s [1][2][3] there has been a worldwide recognition of the need to conduct trials of medicines used in children as a mechanism to improve the health of children [4][5][6][7]. Significant advances in child health have resulted from the conduct of paediatric trials.…”

“…Relying on adult safety and efficacy data when prescribing in children can have unpredictable and tragic effects [4,17,25]. For example, faster metabolism of cyclosporin in children could lead to subtherapeutic concentrations because of under-dosing [26].…”