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
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Access to Novel Medical Products with Dr. Alison Bateman-House
Clinical Research as a Profession with Erika Stevens
Community Engagement in Clinical Trials with Chris Komelasky
Community health system-based research with JoAnne Levy
Postmarket Surveillance Studies with David Rutledge
Human-centered design role in clinical trials with Bruce Hellman and Ben James
Clinical Trial Site Networks with Christian Burns
Heart Failure Clinical Trials with Sonna Patel-Raman
Medical Imaging for Clinical Trial Sites with Kelie Luby
Risk Management for Clinical Investigators with Bijan Elahi
5 Strategies for Investigator and Steering Committee Meetings with Kunal Sampat
Clinical Trial Outsourcing with Anca Copaescu
Complexity in Early Phase Clinical Trials with Dr. Oren Cohen
Patient Recruitment in Phase I Studies with Dr. Graham Wood
Medical Imaging in Clinical Trials with Elizabeth Dalton
Clinical Research Data Transparency with Darshan Kulkarni
Launching an NIH Funded Study with Dr. Manish Shah
Introduction to Coverage Analysis with Kelly Willenberg
Clinical Data Management with Mariam Mirgoli
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