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
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. Vaccine. 2018 Jan 29;36(5):751-757. doi: 10.1016/j.vaccine.2017.12.022. Epub 2017 Dec 15. 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. Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 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. Soc Psychiatry Psychiatr Epidemiol. 2017 Mar 27. doi: 10.1007/s00127-017-1362-4. [Epub ahead of print]. PubMed
Gruber S, Chakravarty A, Heckbert SR, Levenson M, Martin D, Nelson JC, Psaty BM, Pinheiro S, Reich CG, Toh S, Walker AM. Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association. Pharmacoepidemiol Drug Saf. 2016 Jul 14. doi: 10.1002/pds.4065. [Epub ahead of print]. PubMed
Nelson JC, Wellman R, Yu O, Cook AJ, Maro JC, Ouellet-Hellstrom R, Boudreau D, Floyd JS, Heckbert SR, Pinheiro S, Reichman M, Shoaibi A. A synthesis of current surveillance planning methods for the sequential monitoring of drug and vaccine adverse effects using electronic health care data. EGEMS (Wash DC). 2016 Sep 6;4(1):1219. eCollection 2016. PubMed
Jackson ML, Peterson D, Nelson JC, Greene SK, Jacobsen SJ, Belongia EA, Baxter R, Jackson LA. Using winter 2009-2010 to assess the accuracy of methods which estimate influenza-related morbidity and mortality. Epidemiol Infect. 2015 Aug;143(11):2399-407. doi: 10.1017/S0950268814003276. Epub 2014 Dec 12.
Henrikson NB, Opel DJ, Grothaus L, Nelson J, Scrol A, Dunn J, Faubion T, Roberts M, Marcuse EK, Grossman DC. Physician communication training and parental vaccine hesitancy: a randomized trial. Pediatrics. 2015 Jun 1. pii: peds.2014-3199. [Epub ahead of print]. PubMed
Nelson JC, Cook AJ, Yu O, Zhao S, Jackson LA, Psaty BM. Methods for observational post-licensure medical product safety surveillance. Stat Methods Med Res. 2015 Apr;24(2):177-93. doi: 10.1177/0962280211413452. Epub 2011 Dec 2. PubMed
Stratton KG, Cook AJ, Jackson LA, Nelson JC. Simulation study comparing exposure matching with regression adjustment in an observational safety setting with group sequential monitoring. Stat Med. 2015 Mar 30;34(7):1117-33. doi: 10.1002/sim.6398. Epub 2014 Dec 15. 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.