Jennifer Clark Nelson, PhD
“As national statistical leaders, we promote the use of rigorous methods that enhance drug and vaccine safety monitoring in the United States.”
Jennifer Clark Nelson, PhD
Director, Biostatistics; Senior Investigator, Kaiser Permanente Washington Health Research Institute
Affiliate Professor of Biostatistics, University of Washington
Jen.Nelson@kp.org
206-287-2004
Biography
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.
Research interests and experience
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Biostatistics
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
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Vaccines & Infectious Diseases
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
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Medication Use & Patient Safety
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
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Aging & Dementia
Biostatistics; statistical issues in longitudinal observational cohort studies
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Cardiovascular Health
Recent publications
Jackson LA, Dunstan M, Starkovich P, Dunn J, Yu O, Nelson JC, Rees T, Zavitkovsky A. Prophylaxis with acetaminophen or ibuprofen for prevention of local reactions to the fifth diphtheria-tetanus toxoids-acellular pertussis vaccination: a randomized, controlled trial. Pediatrics. 2006;117(3):620-5. PubMed
Jackson LA, Nelson JC, Benson P, Neuzil KM, Reid RJ, Psaty BM, Heckbert SR, Larson EB, Weiss NS. Functional status is a confounder of the association of influenza vaccine and risk of all cause mortality in seniors. Int J Epidemiol. 2006;35(2):345-52. Epub 2005 Dec 20. PubMed
Jackson LA, Jackson ML, Nelson JC, Neuzil KM, Weiss NS. Evidence of bias in estimates of influenza vaccine effectiveness in seniors. Int J Epidemiol. 2006;35(2):337-44. Epub 2005 Dec 20. PubMed
Rautaharju PM, Ge S, Nelson JC, Marino Larsen EK, Psaty BM, Furberg CD, Zhang ZM, Robbins J, Gottdiener JS, Chaves PH. Comparison of mortality risk for electrocardiographic abnormalities in men and women with and without coronary heart disease (from the Cardiovascular Health Study). Am J Cardiol. 2006;97(3):309-15. Epub 2005 Dec 1. PubMed
Lydon-Rochelle MT, Holt VL, Nelson JC, Cardenas V, Gardella C, Easterling TR, Callaghan WM. Accuracy of reporting maternal in-hospital diagnoses and intrapartum procedures in Washington State linked birth records. Paediatr Perinat Epidemiol. 2005;19(6):460-71. PubMed
Lydon-Rochelle MT, Nelson JC, Cardenas V, Tomashek KM, Mueller BA, Easterling TR. Validity of maternal and perinatal risk factors reported on fetal death certificates. Am J Public Health. 2005;95:1948-51. Epub 2005 Sep 29.
Jackson LA, Nelson JC, Whitney CG, Neuzil KM, Benson P, Malais D, Baggs J, Mullooly J, Black S, Shay DK. Assessment of the safety of a third dose of pneumococcal polysaccharide vaccine in the Vaccine Safety Datalink population. Vaccine. 2006;24(2):151-6. Epub 2005 Aug 22. PubMed
Lydon-Rochelle MT, Holt VL, Cardenas V, Nelson JC, Easterling TR, Gardella C, Callaghan WM. The reporting of pre-existing maternal medical conditions and complications of pregnancy on birth certificates and in hospital discharge data. Am J Obstet Gynecol. 2005;193(1):125-34. PubMed
Detrano RC, Anderson M, Nelson J, Wong ND, Carr JJ, McNitt-Gray M, Bild DE. Coronary calcium measurements: effect of CT scanner type and calcium measure on rescan reproducibility--MESA study. Radiology. 2005;236(2):477-84. PubMed
Jackson LA, Neuzil KM, Whitney CG, Starkovich P, Dunstan M, Yu O, Nelson JC, Feikin DR, Shay DK, Baggs J, Carste B, Nahm MH, Carlone G. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2005;23(28):3697-703. PubMed
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Honors from the Health Care Systems Research Network for early career achievements and manuscript of the year
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COVID-19 vaccines and serious reactions: 3 questions answered
Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.
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