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Optimising Trial Design Across the Ages




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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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About the authors


Michael Oldham is a Medical Director at Medpace and has over 10 years of experience in clinical research and drug development. His therapeutic expertise and interests span many areas of child and adult neurology, including epilepsy, neonatal neurology, genetics, movement disorders, and neurodevelopmental disorders.

Michelle Petersen is a Director in Clinical Trial Management who has specialised in rare disease research over the majority of her 11 years at Medpace, with a particular interest in neurological and advanced therapies. She is part of the rare disease consortium and looks forward to the continuing accelerating advancements in rare disease research.

Katharine Shore is a Manager in Regulatory Submissions at Medpace with 10 years of regulatory and site start-up experience in clinical research. Her primary focus is on rare and orphan disease trials, including gene therapy, with special attention and interest in paediatric trials. She is thrilled to see the continued enthusiasm and growth occurring throughout these therapeutic areas.

Christina Vonderhaar is a Director in Regulatory Affairs at Medpace with over 10 years of clinical research experience. She has direct experience developing and implementing regulatory strategies and supporting global applications for rare and orphan diseases that impact the paediatric population.
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