In this free webinar, explore strategies to address the unique challenges of developing improved medicines for children with both rare and non-rare diseases. Attendees will learn about innovative clinical trial solutions, including modern statistical methodology approaches, modeling, simulation and extrapolation of efficacy and safety from other populations. The featured speakers will discuss working with patient advocacy groups, the patient's families and the application of patient-centric trial principles to improve recruitment, the patient consent process and compliance and more.
TORONTO, Aug. 16, 2023 /PRNewswire-PRWeb/ -- There remains a crucial need to include children in clinical development as historically they have been underrepresented in clinical trials. This is due to the complexities of including children, their vulnerabilities and the lack of motivation for drug developers to pursue marketing authorization for pediatric populations. These challenges faced in developing pediatric medicine are not dissimilar to those encountered in orphan drug development and often overlap, with rare pediatric diseases being particularly disadvantaged.
With limited experience among stakeholders in regulating and conducting pediatric clinical trials, several factors contribute to the lagging availability of scientifically tested and approved treatments for these vulnerable populations, including:
- small population sizes and the need for age-appropriate formulations
- ethical conservatism and regulatory restrictions
- specific ADME considerations and limitations in blood sampling
- differences in body size, development and compliance during puberty
- particularities of neonates and infants contributing to heterogeneity
- the involvement of families in treatment and in pediatric clinical trials
Having recognized this, Pediatric and Rare diseases legislation adopted in US, EU and in many other countries have addressed the need for drug development in these neglected populations. However, while progress has been made many conditions are still without approved treatments and healthcare professionals relying on off-label options or inadequate studies.
By conducting well-designed and ethically conducted pediatric clinical trials, the safety and effectiveness of medications for the youngest patients can be improved and their overall healthcare outcomes enhanced.
Join this webinar to learn about shaping the future of therapeutic clinical development in pediatric clinical trials.
Join experts from Allucent, Richard Vesely, Vice President, Regulatory Strategy; Vanessa Beddo, PhD, Vice President, Biostatistical Consulting; Maria-Cruz Morillo, Global Therapeutic Operations Lead, Rare Diseases; and Jessica K. Roberts, Director, Pharmacometrics, for the live webinar on Tuesday, September 12, 2023, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On.
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