Importance of Including Paediatric Experts in Clinical Trials

Echocardiogram is essential for evaluating the heart's structure and function, especially in clinical trials assessing efficacy or safety endpoints. A recent case highlighted the importance of Ethics Committees (EC) reviewing protocol deviations, such as the non-performance of Echocardiograms due to equipment failure. This situation was classified as a protocol violation due to the potential risk to participants. The EC recommended halting participant enrollment until the hospital's echo machine was functional and suggested amendments to the informed consent document if participants were to be sent to external imaging centers.

In another instance, the absence of a paediatrician from an EC meeting due to a conflict of interest raised questions about the review process for a vaccine trial. Regulations mandate that clinical trials in the paediatric population should be reviewed by an EC that includes members knowledgeable about paediatric, ethical, clinical, and psychosocial issues. The absence of such an expert led to the postponement of the discussion to ensure a complete quorum and informed decision-making.

These cases underscore the critical role of paediatric experts in the ethical review and conduct of clinical trials involving children, ensuring the safety and rights of young participants are protected.