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Explore the intersection of clinical trials, electronic medical records, and artificial intelligence in this 54-minute conference talk that examines critical delays in drug development for pediatric and pregnant populations. Learn about the significant 10-year lag between adult drug licensure and approval for children and pregnant women, and discover how EMR data retrieval combined with AI tools could revolutionize clinical protocol development and regulatory submissions. Examine the current challenges in Pediatric Investigation Plans (PIP) and Pediatric Study Plans (PSP) through real-world examples from the IMPAACT network protocols. Analyze a decade of data showing gaps and delays in TB and HIV treatment studies, focusing on study oversight, interim analyses, trial master files, and regulatory submissions to both FDA and EMA. Understand how creative planning incorporating AI and EMR tools could provide more timely and effective alternatives for clinical trial development, ultimately accelerating the availability of safe and effective treatments for vulnerable populations.
