Ethical guidelines have recommended special protection for children in research. All research involving human subjects requires consent, but consent and assent procedures and requirements are more complicated in children. This standard development group aims to provide guidance on how to best recruit children to clinical research and to obtain appropriate consent and assent in an efficient and ethical manner.
Our goal is to provide guidelines for (1) the decision when to install a DMC, the composition of a DMC and the tasks and responsibilities of a DMC and for (2) obtaining adequate sample sizes in pediatric randomised clinical trials. The guidelines will preferably be based on empirical evidence. In the absence of suitable evidence the guideline will be based on consensus. The target group consists of all professionals involved in clinical research with children, including funders, statisticians, ethics committees, Data Monitoring Committees, regulators, and journal editors.
Distinctive response to treatments across the pediatric age-range can be anticipated. Age groups have been used as a proxy marker of exposure for important biological, developmental, and psychological stages and are widely used for population health, clinical care and research. However the approach in paediatrics has been inconsistent, resulting in inadequate data for assessment of the presence of a true age-treatment interaction and clinically applicable decision-making. This standard group aims to provide guidance to trialists on: the importance of considering appropriate age subgroups in trial design; how to approach age subgroup delineation for a condition of interest and the evolving evidence surrounding age-treatment interactions.