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.
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
Klein NP, Lewis N, Goddard K, Fireman B, Zerbo O, Hanson KE, Donahue JG, Kharbanda EO, Naleway A, Nelson JC, Xu S, Yih WK, Glanz JM, Williams JTB, Hambidge SJ, Lewin BJ, Shimabukuro TT, DeStefano F, Weintraub ES. Surveillance for adverse events after COVID-19 mRNA vaccination. JAMA. 2021 Oct 12;326(14):1390-1399. doi: 10.1001/jama.2021.15072. PubMed
Berrueta M, Ciapponi A, Bardach A, Cairoli FR, Castellano FJ, Xiong X, Stergachis A, Zaraa S, Meulen AS, Buekens P; Scoping Review Collaboration Group. Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: a scoping review. BMC Pregnancy Childbirth. 2021 Mar 17;21(1):217. doi: 10.1186/s12884-021-03686-9. PubMed
Bann MA, Carrell DS, Gruber S, Shinde M, Ball R, Nelson JC, Floyd JS. Identification and validation of anaphylaxis using electronic health data in a population-based setting. Epidemiology. 2021 Feb 2. doi: 10.1097/EDE.0000000000001330. [Epub ahead of print]. PubMed
Panagiotakopoulos L, McCarthy NL, Tepper NK, Kharbanda EO, Lipkind HS, Vazquez-Benitez G, McClure DL, Greenberg V, Getahun D, Glanz JM, Naleway AL, Klein NP, Nelson JC, Weintraub ES. Evaluating the association of stillbirths after maternal vaccination in the Vaccine Safety Datalink. Obstet Gynecol. 2020 Dec;136(6):1086-1094. doi: 10.1097/AOG.0000000000004166. PubMed
Shi X, Wellman R, Heagerty PJ, Nelson JC, Cook AJ. Safety surveillance and the estimation of risk in select populations: Flexible methods to control for confounding while targeting marginal comparisons via standardization. Stat Med. 2020;39(4):369-386. doi: 10.1002/sim.8410. Epub 2019 Dec 10. PubMed
Shi X, Miao W, Nelson JC, Tchetgen E. Multiply robust causal inference with double negative control adjustment for categorical unmeasured confounding. J R Stat Soc Ser B Stat Methodol. 2020 Apr;82(2):521-540. doi: 10.1111/rssb.12361. Epub 2020 Jan 22. PubMed
Nelson JC, Ulloa-Pe'rez 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. J Clin Epidemiol. 2019 May 17. pii: S0895-4356(17)30857-0. doi: 10.1016/j.jclinepi.2019.04.012. [Epub ahead of print]. PubMed
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 vacc J Clin Epidemiol. 2019 Sep; 113:114-122. PubMed
Shortreed SM, Cook AJ, Coley RY, Bobb JF, Nelson JC. Challenges and opportunities for using big health care data to advance medical science and public health. Am J Epidemiol. 2019 May 1;188(5):851-861. doi: 10.1093/aje/kwy292. PubMed
McClure JB, Anderson ML, Krakauer C, Blasi P, Bush T, Nelson J, Catz SL. Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial. Transl Behav Med. 2019 Feb 12. pii: 5316179. doi: 10.1093/tbm/ibz009. [Epub ahead of print]. PubMed
Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.
Dr. Jennifer Nelson explains how KP scientists are helping the CDC and FDA keep an eye out for rare adverse events.
New funding will establish an innovation center, to be led by Harvard Pilgrim in partnership with KPWHRI and others.
KPWHRI launches a phone-based recruitment pilot project in May. Outreach to diverse populations is key.