Jennifer Clark Nelson, PhD

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“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

Senior Investigator and Director of Biostatistics, Kaiser Permanente Washington Health Research Institute

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 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.

Research interests and experience

  • 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

  • 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

  • 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

  • Aging & Dementia

    Biostatistics; statistical issues in longitudinal observational cohort studies

  • Cardiovascular Health

Recent publications

Jackson LA, Yu O, Nelson J, Belongia EA, Hambidge SJ, Baxter R, Naleway A, Nordin J, Baggs J, Iskander J. Risk of medically attended local reactions following diphtheria toxoid containing vaccines in adolescents and young adults: A Vaccine Safety Datalink study. Vaccine. 2009;27(36):4912-6. Epub 2009 Jun 28. PubMed

Jackson ML, Nelson JC, Jackson LA. Risk factors for community-acquired pneumonia in immunocompetent seniors. J Am Geriatr Soc. 2009;57(5):882-8. Epub 2009 Apr 21. PubMed

Nelson JC, Jackson ML, Weiss NS, Jackson LA. New strategies are needed to improve the accuracy of influenza vaccine effectiveness estimates among seniors. J Clin Epidemiol. 2009;62(7):687-94. Epub 2009 Jan 4. PubMed

Dublin S, Jackson ML, Nelson JC, Weiss NS, Larson EB, Jackson LA. Statin use and risk of community acquired pneumonia in older people: population based case-control study. BMJ. 2009;338:b2137. doi: 10.1136/bmj.b2137. PubMed

Jackson LA, Yu O, Belongia EA, Hambidge SJ, Nelson J, Baxter R, Naleway A, Gay C, Nordin J, Baggs J, Iskander J. Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study. BMC Infect Dis. 2009;9:165. PubMed

Jackson ML, Nelson JC, Weiss NS, Neuzil KM, Barlow W, Jackson LA. Influenza vaccination and risk of community-acquired pneumonia in immunocompetent elderly people: a population-based, nested case-control study. Lancet. 2008;372(9636):398-405. PubMed

Nelson JC, Jackson M, Yu O, Whitney CG, Bounds L, Bittner R, Zavitkovsky A, Jackson LA. Impact of the introduction of pneumococcal conjugate vaccine on rates of community acquired pneumonia in children and adults. Vaccine. 2008;26(38):4947-54. Epub 2008 Jul 26. PubMed

Jackson LA, Starkovich P, Dunstan M, Yu O, Nelson J, Dunn J, Rees T, Zavitkovsky A, Maus D, Froeschle JE, Decker M. Prospective assessment of the effect of needle length and injection site on the risk of local reactions to the fifth diphtheria-tetanus-acellular pertussis vaccination. Pediatrics. 2008;121(3):e646-52. PubMed

Nelson JC, Jackson ML, Jackson LA. Effectiveness of influenza vaccination. N Engl J Med. 2007;357(26):2728-9; author reply 2730-1. PubMed

Jackson ML, Weiss NS, Nelson JC, Jackson LA. To rule out confounding, observational studies of influenza vaccine need to include analyses during the "preinfluenza period". Arch Intern Med. 2007;167(14):1553-4. PubMed

 

Vaccine safety

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COVID-19 vaccines and serious reactions: 3 questions answered

Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.

Vaccine Safety

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Biostatisticians track COVID-19 vaccine safety

Dr. Jennifer Nelson explains how KP scientists are helping the CDC and FDA keep an eye out for rare adverse events.

drug safety

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FDA to expand drug-safety monitoring capacity

New funding will establish an innovation center, to be led by Harvard Pilgrim in partnership with KPWHRI and others.

news

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Washington state members begin joining the KP research biobank

KPWHRI launches a phone-based recruitment pilot project in May. Outreach to diverse populations is key.