Presentations: Advancing the Development of Pediatric Therapeutics (ADEPT): Application of "Big Data" to Pediatric Safety Studies

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• Therapeutics in children: great progress, now let's fill in the gaps (PDF - 4.06MB)
  Robert Califf, MD
• Regulatory context - “Big Data” and pediatrics at the Food and Drug Administration (PDF- 138KB)
  Mona Khurana, MD
• Reflections on the findings and conclusions of the  European Medicines Agency (EMA) Workshop on “Big Data” and healthcare (PDF - 2.86MB)
  Alison Cave, PhD
• How can we use medical records to create “Big Data” for analysis of safety signals? (PDF - 2.96MB)
  Mark Hoffman, PhD
• Data-driven healthcare: visual analytics for exploration and prediction of clinical data (PDF - 9.18MB)
  Adam Perer, PhD
• "Big Data" in analysis of streaming physiologic data: implications for health care (PDF - 2.38MB)
  Rishikesan Kameleswaran, PhD
• Large-scale analysis to transform the evidence generation process: lessons for the Observational Health Data Sciences and Informatics (OHDSI) collaborative (PDF - 5.21MB)
  Patrick Ryan, PhD
• Medical product safety surveillance research in multi-site settings (PDF - 2.4MB)
  Jeff Brown, PhD
• European perspectives on the use of "Big Data" in health care research (PDF - 1.26MB)
  Mark Turner, MD, PhD
• Pharmaceutical and Medical Devices Agency's (PMDA) plans for use of "Big Data" in healthcare (PDF - 2.46MB)
  Shohko Sekine, MS and Michiyo Sakiyama, MD
• “Big Data” to generate biomarkers for pediatric precision medicine: use and misuse (PDF - 5.56MB)
  Isaac Kohane, MD, PhD
• Responsible and transparent use of “Big Data ” to advance pediatric research (PDF - 4.5MB)
  Finale Doshi-Velez, PhD
• The need for "Big Data" in pediatrics (PDF - 3.79MB)
  Miriam Sturkenboom, PhD
• Prevention of adverse drug reactions (ADRs) in childhood by identifying predictive genomic markers for specific ADRs: Use of “Big Data” (PDF - 2.58MB)
  Bruce Carleton, PharmD
• Developmental and environmental considerations in analysis of “Big Data” in pediatrics (PDF - 1.58MB)
  Jennifer Goldman, MD, MS
• Consideration of factors occurring between pediatric exposures and outcomes that could confound signals derived from “Big Data” (PDF - 145KB)
  Allen Mitchell, MD
• Workshop Summary (PDF - 1.77MB)
  William Cooper, MD, MPH

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