CTP 015: Real-World Insights and Epidemiology with Dr. Christina Mack

Christina Mack, Ph.D., MSPH is Sr. Director of Epidemiology and Clinical Evidence in the IQVIA Real-World Insights division. She is a recognized expert in effectiveness studies for medical devices and pharmaceutical products, sports injury research, and pharmacoepidemiology methods including the use of external comparators, propensity scores, instrumental variables, and missing data.   Her work focuses on the use of electronic health record systems and claims data for research, with a focus in study design methodology, maternal health, orthopedics, oncology, and infectious disease.   Dr. Mack oversees development of large evidence hubs and novel studies that augment primary data collection with existing data and leads the IQVIA Injury Surveillance and Analytics team which serves as the epidemiologic research arm of the NFL and NBA. She is an epidemiologist and computer engineer by training, with Ph.D. and master’s degrees from the University of North Carolina at Chapel Hill and an engineering degree from the University of Notre Dame.   Currently, Dr. Mack holds an academic appointment as Adjunct Assistant Professor of Epidemiology at the University of North Carolina at Chapel Hill and serves on the Advisory Board of the Carolina Health Informatics Program. Dr. Mack has published manuscripts in leading journals and authored several chapters in the Agency for Healthcare Research and Quality (AHRQ) landmark publication "Registries for Evaluating Patient Outcomes: A User's Guide" on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks.   She is a speaker at regulatory, governmental, and academic forums on epidemiologic methods and novel study designs as well as careers in research. Last but not the least, she has over fifteen years of scientific and technical experience working for Johnson & Johnson, GlaxoSmithKline, IBM, and the World Health Organization in addition to her work at IQVIA. Her regulatory experience includes advising the FDA, most recently as faculty at the 2017 MDEpiNet Annual Meeting and at the FDA Cardiac Research Safety Consortium discussing novel research methods and use of electronic medical records for outcomes trials.   Please join me in welcoming Dr. Mack on the Clinical Trial Podcast. Resources and organizations mentioned in this episode: IQVIA Food and Drug Administration (FDA) Pubmed ClinicalTrials.Gov Norwegian Mother and Child Cohort Study (MoBa) Global Fund Clinton Foundation World Health Organization and HIV IBM Johnson and Johnson Organization of Eastern Caribbean Islands Outcomes Sciences MIT Harvard School of Public Health University of Lusaka Quintiles Healthcare Business Women's Association Agency for Healthcare Research and Quality (AHRQ) landmark publication “Registries for Evaluating Patient Outcomes: A User’s Guide” on the topics of designing registries for studies of medical devices, selection of data elements for observational research, missing data, and research networks American College of Cardiology National Cancer Institute FDA's Sentinel Initiative NBA NFL MDEpinet University of North Carolina Chapel Hill New York Times People mentioned in this episode: Manuel Prado Dr. Nancy Dreyer Dr. Mark Travis Rob Cahill