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

Curriculum vitae (CV)

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 has provided 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 has also included membership on the Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccines Working 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 has worked with her Kaiser Permanente Washington Health Research Institute (KPWHRI) colleagues Andrea Cook, PhD, and Brian Williamson, 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, also led 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

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

Cook AJ, Wellman RD, Marsh T, Shoaibi A, Tiwari R, Nguyen M, Boudreau D, Weintraub ES, Jackson L, Nelson JC Applying sequential surveillance methods that use regression adjustment or weighting to control confounding in a multi-site, rare event, distributed setting: Part 2 In-Depth Example of a re-analysis of the measles-mumps-rubella-varicella combination vacci 2019 Sep;113:114-122. doi: 10.1016/j.jclinepi.2019.04.019. Epub 2019-05-02. PubMed

Nelson JC, Ulloa-Pérez E, Bobb JF, Maro JC Leveraging the entire cohort in drug safety monitoring: Part 1 Methods for Sequential surveillance that use regression adjustment or weighting to control confounding in a multi-site, rare event, distributed data setting 2019 Aug;112:77-86. doi: 10.1016/j.jclinepi.2019.04.012. Epub 2019-05-18. PubMed

Tseng HF, Sy LS, Qian L, Liu IA, Mercado C, Lewin B, Tartof SY, Nelson J, Jackson LA, Daley MF, Weintraub E, Klein NP, Belongia E, Liles EG, Jacobsen SJ Pneumococcal Conjugate Vaccine Safety in Elderly Adults 2018 Jun;5(6):ofy100. doi: 10.1093/ofid/ofy100. Epub 2018-05-02. PubMed

McClure JB, Bush T, Anderson ML, Blasi P, Thompson E, Nelson J, Catz SL Oral Health Promotion and Smoking Cessation Program Delivered via Tobacco Quitlines: The Oral Health 4 Life Trial 2018 May;108(5):689-695. doi: 10.2105/AJPH.2017.304279. Epub 2018-03-22. 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 2018 Apr;27(4):391-397. doi: 10.1002/pds.4397. Epub 2018-02-15. PubMed

Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, Carnahan RM Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System 2018 Mar;27(3):263-271. doi: 10.1002/pds.4375. Epub 2018-01-10. PubMed

Jackson ML, Phillips CH, Benoit J, Kiniry E, Madziwa L, Nelson JC, Jackson LA The impact of selection bias on vaccine effectiveness estimates from test-negative studies 2017 Dec 15 doi: 10.1016/j.vaccine.2017.12.022. PubMed

McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Corrigendum to "oral health 4 life: design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers". Contemp Clin Trials. 57 (2017) 90-97. 2017 Jul 24. pii: S1551-7144(17)30469-X. doi: 10.1016/j.cct.2017.07.011. [Epub ahead of print]. No abstract available. PubMed

McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017-04-12. PubMed

Glass JE, Rathouz PJ, Gattis M, Joo YS, Nelson JC, Williams EC Intersections of poverty, race/ethnicity, and sex: alcohol consumption and adverse outcomes in the United States 2017 May;52(5):515-524. doi: 10.1007/s00127-017-1362-4. Epub 2017-03-27. PubMed