Jennifer Clark Nelson, PhD, is a senior investigator and biostatistician with expertise in methods to assess drug and vaccine safety and effectiveness for studies that use large electronic health care data. Dr. Nelson provides national statistical leadership as a methods core lead for the Food and Drug Administration (FDA)’s Sentinel Initiative, an active surveillance system for monitoring the safety of all FDA-regulated medical products after they have reached the market. She also leads methodological research within the Centers for Disease Control and Prevention-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving seven managed care organizations that has monitored immunization safety in the United States since 1990.
As part of both the VSD and Sentinel projects, Dr. Nelson works with her Kaiser Permanente Washington Health Research Institute (KPWHRI) colleagues Andrea Cook, PhD, and David Carrell, PhD, to pilot and scale up innovative sequential monitoring, machine learning, and natural language processing approaches that rapidly and accurately identify adverse events not detected in pre-licensure studies. Her 2013 study of the safety of a pentavalent combination DTaP-IPV-Hib (Pentacel) childhood vaccine put some of these ideas into practice and was selected as one of the American Journal of Epidemiology’s 10 best articles of the year. She and her clinical KPWHRI research partner, Lisa Jackson, MD, MPH, lead the CDC’s surveillance effort to proactively monitor the safety of the new herpes zoster vaccine for adults (Shingrix).
Dr. Nelson is an affiliate professor in biostatistics at the University of Washington (UW) and has been KPWHRI’s director of biostatistics since 2014. In collaboration with the UW, she and Dr. Cook co-founded the Seattle Symposium on Health Care Data Analytics, a conference designed to confront challenges and promote learning from electronic health record data to advance health and health care. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in vaccine safety.
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 longitudinal observational cohort studies
Yanez ND III, Kronmal RA, Nelson JC, Alonzo TA. Analyzing change in clinical trials using quasi-likelihood. Journal of Applied Statistics. 2002;29(8):1135-1145.
Rautaharju PM, Nelson JC, Kronmal RA, Zhang Z, Robbins J, Gottdiener J, Furberg CD, Manolio T, Fried L. Usefulness of T-axis deviation as an independent risk indicator for incident cardiac events in older men and women free from coronary heart disease (the Cardiovascular Health Study). Am J Cardiol. 2001; 88(2):118-23. PubMed
Nelson JC, Pepe MS. Statistical description of interrater variability in ordinal ratings. Statistical Methods in Medical Research. 2000;9(5):475-496. PubMed
Ludman EJ, McBride CM, Nelson JC, Curry SJ, Grothaus LC, Lando HA, Pirie PL. Stress, depressive symptoms, and smoking cessation among pregnant women. Health Psychol. 2000;19(1):21-7. PubMed
McBride CM, Curry SJ, Lando HA, Pirie PL, Grothaus LC, Nelson JC. Prevention of relapse in women who quit smoking during pregnancy. Am J Public Health. 1999;89(5):706-11. PubMed
Hellerstedt WL, Pirie PL, Lando HA, Curry SJ, McBride CM, Grothaus LC, Nelson JC. Differences in preconceptional and prenatal behaviors in women with intended and unintended pregnancies. Am J Public Health. 1998;88(4):663-6. PubMed
McBride CM, Curry SJ, Grothaus LC, Nelson JC, Lando H, Pirie PL. Partner smoking status and pregnant smoker's perceptions of support for and likelihood of smoking cessation. Health Psychol. 1998;17(1):63-9. PubMed
Li R, Weintraub E, McNeil MM, Kulldorff M, Lewis EM, Nelson J, Xu S, Qian L, Klein NP, Destefano F. Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method. Pharmacoepidemiol Drug Saf. 2018 Feb 15. doi: 10.1002/pds.4397. [Epub ahead of print]. PubMed
Pingray V, Belizan M, Matthews S, Zaraa S, Berrueta M, Noguchi LM, Xiong X, Gurtman A, Absalon J, Nelson JC, Panagiotakopoulos L, Sevene E, Munoz FM, Althabe F, Mwamwitwa KW, Cairoli FR, Anderson SA, McClure EM, Guillard C, Nakimuli A, Stergachis A, Buekens P. Using maternal and neonatal data collection systems for coronavirus disease 2019 (COVID-19) vaccine active safety surveillance in low- and middle-income countries: an international modified Delphi study. Gates Open Res. 2021; 5:99 (https://doi.org/10.12688/gatesopenres.13305.1).
Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.
Dr. Jennifer Nelson explains how KP scientists are helping the CDC and FDA keep an eye out for rare adverse events.
New funding will establish an innovation center, to be led by Harvard Pilgrim in partnership with KPWHRI and others.
KPWHRI launches a phone-based recruitment pilot project in May. Outreach to diverse populations is key.