Ethical Conduct of Paediatric Clinical Trials: Issues and Challenges

Paediatric is considered as subgroup of a vulnerable population at risk for exploitation and given a special protection in clinical studies. They are legally not able to provide consent and the extent to which paediatric patients are able to understand the meaning, risks and potential benefits of participating in clinical trials varies according to their age(s) and background. Trials are performed to evaluate the safety and efficacy of medicinal product used by paediatrics. Without the studies, medicinal product used by paediatrics will be limited to extrapolation from adult studies or off label use for indications that have not been studied in paediatrics, by keeping paediatric patients at increased risk of adverse effects. Growth and maturation can alter their kinetics, toxicities and the end organ responses of drug used by paediatrics compared to adults. The enrolment of paediatrics in investigation must be considered scientifically necessary before the evaluation of whether the research interventions or procedures present an appropriate balance of risk and potential benefit. The studies must be made in different age group(s) of paediatrics and safety of investigational drugs must be studied to identify potential severe side effects and adverse events are the considerable points during the paediatric drug development.