Jennifer Nelson is a biostatistician with expertise in designing and analyzing vaccine safety and effectiveness studies. She is particularly interested in developing new methods to overcome the challenges associated with using large, administrative health care utilization databases in vaccine research. Although her primary focus is vaccines, her methodological work has broader implications for studying the safety and effectiveness of other medical products, such as drugs, medical devices, and biologics.

As part of the Vaccine Safety Datalink (VSD) project, Dr. Nelson works with Group Health Research Institute (GHRI) colleague Andrea Cook, PhD, to improve statistical methods for post-marketing surveillance studies of new vaccines. Their goal is to develop new sequential testing approaches that will rapidly and accurately identify adverse events not detected in pre-licensure studies. Dr. Nelson also collaborates with the Food and Drug Administration to evaluate statistical methods for more general use in post-marketing safety surveillance of other medical products. In her vaccine effectiveness work, Dr. Nelson recently shed light on the limitations of the methods that previous epidemiological research used to assess the effectiveness of influenza vaccine in preventing illness and death in seniors. Her paper was the first to comprehensively describe the challenges in methods for assessing the public health benefit of influenza vaccine in the elderly; it was also the first to recommend specific new strategies to improve estimates of vaccine effectiveness. By sharing these statistical insights across a broad audience, she is helping bridge the gap between biostatistics and epidemiology and hoping to encourage widespread use of more rigorous methods. Dr. Nelson is excited to continue evaluating and developing methods to increase understanding of disease prevention and vaccine safety—and working to bring new, improved methods into the mainstream.

Dr. Nelson heads the Group Health Research Institute (GHRI) biostatistics unit, which includes seven PhD- and six Masters-level biostatisticians and five graduate students. She also chairs the VSD's Methodology Working Group, leading and setting priorities for collaboration on vaccine safety methods by statisticians at the VSD's eight sites. She is a past program chair of the American Statistical Association's Statistics in Epidemiology section and an affiliate assistant professor in biostatistics at the University of Washington (UW). Before joining Group Health, Dr. Nelson served for four years as the Deputy Director of the Multi-Ethnic Study of Atherosclerosis (MESA) Coordinating Center at the UW.

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Recent publications

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

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 Apr 1. doi: 10.1002/pds.3418. [Epub ahead of print]. 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

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.

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. LID - 10.1002/pds.3340 [doi] 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.

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

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

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

Gagne JJ, Fireman B, Ryan PB, Maclure M, Gerhard T, Toh S, Rassen JA, Nelson JC, Schneeweiss S. Design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:32-40. doi: 10.1002/pds.2316. PubMed

Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, Hennessy S, Nelson JC, Racoosin JA, Robb M, Schneeweiss S, Toh S, Weiner MG. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:1-8. doi: 10.1002/pds.2343. 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

To view more publications, please see Dr. Nelson's CV.

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