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

Director, Biostatistics; Senior Investigator, 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

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

Nelson JC, Kronmal RA, Carr JJ, McNitt-Gray MF, Wong ND, Loria CM, Goldin JG, Williams OD, Detrano R. Measuring coronary calcium on CT images adjusted for attenuation differences. Radiology. 2005;235(2):403-14. PubMed

Carr JJ, Nelson JC, Wong ND, McNitt-Gray M, Arad Y, Jacobs DR Jr, Sidney S, Bild DE, Williams OD, Detrano RC. Calcified coronary artery plaque measurement with cardiac CT in population-based studies: standardized protocol of Multi-Ethnic Study of Atherosclerosis (MESA) and Coronary Artery Risk Development in Young Adults (CARDIA) study. Radiology. 2005;234(1):35-43. PubMed

Robbins J, Nelson JC, Rautaharju PM, Gottdiener JS. The association between the length of the QT interval and mortality in the cardiovascular health study. Am J Med. 2003;115(9):689-94. PubMed

Bild DE, Bluemke DA, Burke GL, Detrano R, Diez Roux AV, Folsom AR, Greenland P, Jacob DR Jr, Kronmal R, Liu K, Nelson JC, O'Leary D, Saad MF, Shea S, Szklo M, Tracy RP. Multi-ethnic study of atherosclerosis: objectives and design. Am J Epidemiol. 2002; 156(9):871-881. PubMed

 

Vaccine research

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COVID-19 vaccines safe for people who are pregnant

New study supports a growing body of data that shows the vaccines are safe during pregnancy.

News

HCSRN 2022 Awards-Portrait images of Julie Richards and Jen Nelson

Richards and Nelson earn research awards

Honors from the Health Care Systems Research Network for early career achievements and manuscript of the year

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.