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 electronic health care data.
Dr. Nelson provides national statistical leadership and strategic direction for the U.S. 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 safety research within the Centers for Disease Control and Prevention (CDC)-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving 13 health care organizations that has monitored immunization safety in the United States since 1990. Her CDC service further includes membership on the Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical Work Group to help inform recommendations on the use of these vaccines in the U.S.
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. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in vaccine safety. She is also a fellow of the American Statistical Association.
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
Nelson JC, Marsh T, Lumley T, Larson EB, Jackson LA, Jackson ML; Vaccine Safety Datalink Team. Validation sampling can reduce bias in health care database studies: an illustration using influenza vaccination effectiveness. J Clin Epidemiol. 2013 Aug;66(8 Suppl):S110-21. doi: 10.1016/j.jclinepi.2013.01.015. PubMed
Dublin S, Baldwin E, Walker RL, Christensen LM, Haug PJ, Jackson ML, Nelson JC, Ferraro J, Carrell D, Chapman WW. Natural language processing to identify pneumonia from radiology reports. Pharmacoepidemiol Drug Saf. 2013 Aug;22(8):834-41. doi: 10.1002/pds.3418. Epub 2013 Apr 1. PubMed
Jackson ML, Nelson JC. The test-negative design for estimating influenza vaccine effectiveness. Vaccine. 2013 Apr 19;31(17):2165-8. doi: 10.1016/j.vaccine.2013.02.053. Epub 2013 Mar 13. PubMed
Glanz JM, Newcomer SR, Narwaney KJ, Hambidge SJ, Daley MF, Wagner NM, McClure DL, Xu S, Rowhani-Rahbar A, Lee GM, Nelson JC, Donahue JG, Naleway AL, Nordin JD, Lugg MM, Weintraub ES. A population-based cohort study of undervaccination in 8 managed care organizations across the United States. JAMA Pediatr. 2013 Mar 1;167(3):274-81. doi: 10.1001/jamapediatrics.2013.502. Epub 2013 Jan 21. PubMed
Jackson LA, Peterson D, Nelson JC, Marcy SM, Naleway AL, Nordin JD, Donahue JG, Hambidge SJ, Balsbaugh C, Baxter R, Marsh T, Madziwa L, Weintraub E. Vaccination site and risk of local reactions in children 1 through 6 years of age. Pediatrics. 2013 Feb;131(2):283-9. doi: 10.1542/peds.2012-2617. Epub 2013 Jan 14. PubMed
Nelson JC, Yu O, Dominguez C, Cook AJ, Peterson D, Greene SK, Yih K, Daley MF, Jacobsen SJ, Klein NP, Weintraub E, Jackson LA. Adapting group sequential methods to observational postlicensure vaccine safety surveillance: results of a pentavalent combination DTaP-IPV-Hib vaccine safety study. Am J Epidemiol. 2013 Jan 15;177(2):131-41. doi: 10.1093/aje/kws317. Epub 2013 Jan 4. PubMed
Dublin S, Walker RL, Jackson ML, Nelson JC, Weiss NS, Jackson LA. Angiotensin-converting enzyme inhibitor use and pneumonia risk in community-dwelling older adults: results from a population-based case-control study. Pharmacoepidemiol Drug Saf. 2012 Nov;21(11):1173-82. doi: 10.1002/pds.3340. Epub 2012 Sep 5. PubMed
Zhao S, Cook AJ, Jackson LA, Nelson JC. Statistical performance of group sequential methods for observational post-licensure medical product safety surveillance: a simulation study. Stat Interface. 2012; 5:381-90.
Xu S, Zeng C, Newcomer S, Nelson JC, Glanz J. Use of fixed effects models to analyze self-controlled case series data in vaccine safety studies. J Biom Biostat. 2012 Apr 19;Suppl 7:006.
Wong ND, Nelson JC, Granston T, Bertoni AG, Blumenthal RS, Carr JJ, Guerci A, Jacobs DR Jr, Kronmal R, Liu K, Saad M, Selvin E, Tracy R, Detrano R. Metabolic syndrome, diabetes, and incidence and progression of coronary calcium: the multiethnic study of atherosclerosis study. JACC Cardiovasc Imaging. 2012;5(4):358-66. PubMed
KPWHRI researchers analyzed data from more than 640,000 vaccine doses to understand risk of severe reactions.
New study supports a growing body of data that shows the vaccines are safe during pregnancy.
Honors from the Health Care Systems Research Network for early career achievements and manuscript of the year
Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.