Designed by macrovector / Freepik
Global regulatory authorities continue to have an increasing interest in allowing both paediatric and adult patients in clinical trials. Additionally, rapidly expanding numbers of clinical development programmes in rare diseases have led to key challenges in recruitment. Global outreach is often necessary to achieve targeted enrolment across a patient population of varying ages. Therefore, it is important to discuss the regulatory, start-up, operational, and medical challenges and considerations of clinical trials that include both paediatric and adult patients.
Regulatory
There are numerous regulatory considerations for trials involving paediatric patients. Global drug development strategies need to incorporate an understanding of logistical, scientific, and regulatory components for inclusion of paediatric patients. Regulators such as the FDA and EMA both require paediatric plans to ensure appropriate development of drugs and biologics in the paediatric population. However, in some scenarios, particularly involving rare or orphan diseases that target younger populations, discussions regarding the inclusion of paediatric patients may occur outside of standard procedures or earlier in the clinical development programme. Therefore, if a trial intends to include paediatric patients, clinical development must be proactively aligned with and support future labelling prior to implementation of the trial.
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