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
Xu S, Newcomer SR, Nelson JC, Chan L, McClure D, Pan Yi, Zeng C, Glanz J. Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design. Biom J. 2014 May;56(3):513-25. doi: 10.1002/bimj.201300012. Epub 2014 Jan 9. PubMed
Weiner SD, Ahmed HN, Jin Z, Cushman M, Herrington DM, Nelson JC, Di Tullio MR, Homma S. Systemic inflammation and brachial artery endothelial function in the Multi-Ethnic Study of Atherosclerosis (MESA). Heart. 2014 Jun;100(11):862-6. doi: 10.1136/heartjnl-2013-304893. Epub 2014 Apr 8. PubMed
Daley MF, Yih WK, Glanz JM, Hambidge SJ, Narwaney KJ, Yin R, Li L, Nelson JC, Nordin JD, Klein NP, Jacobsen SJ, Weintraub E. Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine. Vaccine. 2014 May 23;32(25):3019-24. doi: 10.1016/j.vaccine.2014.03.063. Epub 2014 Mar 31. PubMed
Nelson JC, Shortreed SM, Yu O, Peterson D, Baxter R, Fireman B, Lewis N, McClure D, Weintraub E, Xu S, Jackson LA. Integrating database knowledge and epidemiological design to improve the implementation of data mining methods to evaluate vaccine safety in large healthcare databases. Stat Anal Data Min. 2014;7(5):33751.
Glanz JM, Narwaney KJ, Newcomer SR, Daley MF, Hambidge SJ, Rowhani-Rahbar A, Lee GM, Nelson JC, Naleway AL, Nordin JD, Lugg MM, Weintraub ES. Association between undervaccination with diphtheria, tetanus toxoids, and acellular pertussis (DTaP) vaccine and risk of pertussis infection in children 3 to 36 months of age. JAMA Pediatr. 2013 Nov;167(11):1060-4. doi: 10.1001/jamapediatrics.2013.2353. Epub 2013 Sep 9. PubMed
Jackson ML, Yu O, Nelson JC, Naleway A, Belongia EA, Baxter R, Narwaney K, Jacobsen SJ, Shay DK, Jackson LA. Further evidence for bias in observational studies of influenza vaccine effectiveness: the 2009 Influenza A(H1N1) pandemic. Am J Epidemiol. 2013 Oct 15;178(8):1327-36. doi: 10.1093/aje/kwt124. Epub 2013 Aug 26. PubMed
Nelson JC, Marsh T, Lumley T, Larson EB, Jackson LA, Jackson ML; Vaccine Safety Datalink Team. Validation sampling can reduce bias in health care database studies: an illustration using influenza vaccination effectiveness. J Clin Epidemiol. 2013 Aug;66(8 Suppl):S110-21. doi: 10.1016/j.jclinepi.2013.01.015. PubMed
Dublin S, Baldwin E, Walker RL, Christensen LM, Haug PJ, Jackson ML, Nelson JC, Ferraro J, Carrell D, Chapman WW. Natural language processing to identify pneumonia from radiology reports. Pharmacoepidemiol Drug Saf. 2013 Aug;22(8):834-41. doi: 10.1002/pds.3418. Epub 2013 Apr 1. PubMed
Jackson ML, Nelson JC. The test-negative design for estimating influenza vaccine effectiveness. Vaccine. 2013 Apr 19;31(17):2165-8. doi: 10.1016/j.vaccine.2013.02.053. Epub 2013 Mar 13. PubMed
Glanz JM, Newcomer SR, Narwaney KJ, Hambidge SJ, Daley MF, Wagner NM, McClure DL, Xu S, Rowhani-Rahbar A, Lee GM, Nelson JC, Donahue JG, Naleway AL, Nordin JD, Lugg MM, Weintraub ES. A population-based cohort study of undervaccination in 8 managed care organizations across the United States. JAMA Pediatr. 2013 Mar 1;167(3):274-81. doi: 10.1001/jamapediatrics.2013.502. Epub 2013 Jan 21. 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.