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Navigating Clinical Trials: Essential Knowledge fo ...
Pediatric Clinical Trials
Pediatric Clinical Trials
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Video Summary
Dr. Amy Paller discusses pediatric clinical trials, emphasizing their necessity due to children's unique physiological and psychological traits. Historically, trials only involved adults, resulting in children receiving adjusted adult doses, often leading to ineffective or unsafe results. Pediatric trials face challenges like ethical considerations, smaller patient pools, higher costs, and need for tailored formulations. Laws like BPCA and PREA now mandate testing in children, enhancing safety and efficacy assessments. Dr. Paller outlines hurdles such as drug formulation specifics, trial design complexities, and ethical concerns for conducting these trials. She stresses the importance of accurate dosing, minimizing invasive procedures, employing age-appropriate consent processes, and engaging families. Innovative strategies like open-label extensions and remote monitoring can enhance trial recruitment and data collection. Despite challenges, Dr. Paller encourages careful feasibility assessments and possibly investigator-initiated studies to address unmet needs in pediatric dermatology.
Asset Subtitle
by Amy Paller, MD, FAAD
Keywords
pediatric clinical trials
children's unique traits
ethical considerations
BPCA and PREA
drug formulation
innovative strategies
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