Jennifer Nelson is a biostatistician with expertise in methods to assess drug and vaccine safety and effectiveness. She is particularly interested in addressing methodological challenges that arise in post-licensure drug and vaccine safety studies that use large observational health care databases.
Dr. Nelson provides national statistical leadership as the methods core co-lead and senior statistician for the Food and Drug Administration (FDA)’s Mini-Sentinel Initiative, a pilot project to facilitate development of an active surveillance system for monitoring the safety of all FDA-regulated medical products. She also serves as methodology committee chair for the Centers for Disease Control and Prevention-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving 10 managed care organizations that has monitored immunization safety in the Unite States since 1990.
As part of both the VSD and Mini-Sentinel projects, Dr. Nelson works with Group Health Research Institute (GHRI) colleague Andrea Cook, PhD, to improve statistical methods for post-marketing safety surveillance studies of new drugs and vaccines. Their goal is to develop new sequential testing approaches that will rapidly and accurately identify adverse events not detected in pre-licensure studies.
In her vaccine effectiveness work, Dr. Nelson recently shed light on the limitations of the methods that previous epidemiological research used to assess the effectiveness of influenza vaccine in preventing illness and death in seniors. Her paper was the first to comprehensively describe the challenges in methods for assessing the public health benefit of influenza vaccine in the elderly; it was also the first to recommend specific new strategies to improve estimates of vaccine effectiveness. By sharing these statistical insights across a broad audience, she is helping bridge gaps between biostatistics and epidemiology and hoping to encourage widespread use of more rigorous methods and bring new, improved methods into the mainstream.
Dr. Nelson is an affiliate associate professor in biostatistics at the University of Washington (UW). She is also an invited member of the Vaccines Sub-Committee of the International Society for Clinical Biostatistics (ISCB), a group established to facilitate collaboration among statisticians working in vaccine research and disseminate statistical methods for vaccine research worldwide. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in the field of vaccine safety. Before joining Group Health, Dr. Nelson served for four years as the deputy director of the Multi-Ethnic Study of Atherosclerosis (MESA) Coordinating Center at the UW.
Post-marketing drug and vaccine safety study design and analysis; secondary use and misuse of large electronic health care databases for medical research; vaccine effectiveness study methods; sequential testing in observational data settings; methods to assess interrater variability
Biostatistics; post-marketing vaccine safety study design and analysis; influenza vaccine effectiveness in the elderly; methodological issues in large multi-site health care database studies
Biostatistics; post-marketing drug and vaccine safety study design and analysis; safety signal detection methods; methodological issues in large, multi-site health care database studies
Biostatistics; statistical issues in multi-site, longitudinal observational studies; coronary artery calcium CT scoring methods
Stratton KG, Cook AJ, Jackson LA, Nelson JC.Simulation study comparing exposure matching with regression adjustment in an observational safety setting with group sequential monitoring.
Stat Med. 2014 Dec 15. doi: 10.1002/sim.6398. [Epub ahead of print]. PubMed
Jackson ML, Peterson D, Nelson JC, Greene SK, Jacobsen SJ, Belongia EA, Baxter R, Jackson LA.Using winter 2009-2010 to assess the accuracy of methods which estimate influenza-related morbidity and mortality.
Epidemiol Infect. 2014 Dec 12:1-9. [Epub ahead of print].
Bell C, Chakravarty A, Gruber S, Heckbert SR, Levenson M, Martin D, Nelson JC, Pinheiro S, Psaty BM, Reich CG, Schneeweiss S, Shoaibi A, Toh S, Walker AM.Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems.
Pharmacoepidemiol Drug Saf. 2014 Sep 29. doi: 10.1002/pds.3712 [Epub ahead of print]. PubMed
Cook AJ, Wellman RD, Nelson JC, Jackson LA, Tiwari RC.Group sequential method for observational data by using generalized estimating equations: application to Vaccine Safety Datalink.
J R Stat Soc Ser C Appl Stat. 2014 Sep 23.doi: 10.1111/rssc.12075 [Epub ahead of print].