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
Jackson LA, Peterson D, Nelson JC, Marcy SM, Naleway AL, Nordin JD, Donahue JG, Hambidge SJ, Balsbaugh C, Baxter R, Marsh T, Madziwa L, Weintraub E. Vaccination site and risk of local reactions in children 1 through 6 years of age. Pediatrics. 2013 Feb;131(2):283-9. doi: 10.1542/peds.2012-2617. Epub 2013 Jan 14. PubMed
Nelson JC, Yu O, Dominguez C, Cook AJ, Peterson D, Greene SK, Yih K, Daley MF, Jacobsen SJ, Klein NP, Weintraub E, Jackson LA. Adapting group sequential methods to observational postlicensure vaccine safety surveillance: results of a pentavalent combination DTaP-IPV-Hib vaccine safety study. Am J Epidemiol. 2013 Jan 15;177(2):131-41. doi: 10.1093/aje/kws317. Epub 2013 Jan 4. PubMed
Dublin S, Walker RL, Jackson ML, Nelson JC, Weiss NS, Jackson LA. Angiotensin-converting enzyme inhibitor use and pneumonia risk in community-dwelling older adults: results from a population-based case-control study. Pharmacoepidemiol Drug Saf. 2012 Nov;21(11):1173-82. doi: 10.1002/pds.3340. Epub 2012 Sep 5. PubMed
Zhao S, Cook AJ, Jackson LA, Nelson JC. Statistical performance of group sequential methods for observational post-licensure medical product safety surveillance: a simulation study. Stat Interface. 2012; 5:381-90.
Xu S, Zeng C, Newcomer S, Nelson JC, Glanz J. Use of fixed effects models to analyze self-controlled case series data in vaccine safety studies. J Biom Biostat. 2012 Apr 19;Suppl 7:006.
Wong ND, Nelson JC, Granston T, Bertoni AG, Blumenthal RS, Carr JJ, Guerci A, Jacobs DR Jr, Kronmal R, Liu K, Saad M, Selvin E, Tracy R, Detrano R. Metabolic syndrome, diabetes, and incidence and progression of coronary calcium: the multiethnic study of atherosclerosis study. JACC Cardiovasc Imaging. 2012;5(4):358-66. PubMed
Nelson JC, Cook AJ, Yu O, Dominguez C, Zhao S, Greene SK, Fireman BH, Jacobsen SJ, Weintraub ES, Jackson LA. Challenges in the design and analysis of sequentially monitored postmarket safety surveillance evaluations using electronic observational health care data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:62-71. doi: 10.1002/pds.2324. PubMed
Maclure M, Fireman B, Nelson JC, Hua W, Shoaibi A, Paredes A, Madigan D. When should case-only designs be used for safety monitoring of medical products? Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:50-61. doi: 10.1002/pds.2330. PubMed
Cook AJ, Tiwari RC, Wellman RD, Heckbert SR, Li L, Heagerty P, Marsh T, Nelson JC. Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:72-81. doi: 10.1002/pds.2320. PubMed
Fireman B, Toh S, Butler MG, Go AS, Joffe HV, Graham DJ, Nelson JC, Daniel GW, Selby JV. A protocol for active surveillance of acute myocardial infarction in association with the use of a new antidiabetic pharmaceutical agent. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:282-90. doi: 10.1002/pds.2337. 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.