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
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
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
Dublin S, Walker RL, Jackson ML, Nelson JC, Weiss NS, Von Korff M, Jackson LA. Use of opioids or benzodiazepines and risk of pneumonia in older adults: a population-based case-control study. J Am Geriatr Soc. 2011 Oct;59(10):1899-907. doi: 10.1111/j.1532-5415.2011.03586.x. Epub 2011 Sep 13. PubMed
Yu O, Nelson JC, Bounds L, Jackson LA. Classification algorithms to improve the accuracy of identifying patients hospitalized with community-acquired pneumonia using administrative data. Epidemiol Infect. 2011;139:1296-1306. PubMed
Li L, Kulldorff M, Nelson JC, Cook AJ. A propensity score-enhanced sequential analytic method for comparative drug safety surveillance. Stat Biosci. 2011 Sept. 3(1):45-62. doi:10.1007/s12561-011-9034-5.
Jackson ML, Nelson JC, Jackson LA. Why do covariates defined by International Classification of Diseases codes fail to remove confounding in pharmacoepidemiologic studies among seniors? Pharmacoepidemiol Drug Saf. 2011 Aug;20(8):858-65. doi: 10.1002/pds.2160. Epub 2011 Jun 13. PubMed
Jackson LA, Yu O, Nelson JC, Dominguez C, Peterson D, Baxter R, Hambidge SJ, Naleway AL, Belongia EA, Nordin JD, Baggs J. Injection site and risk of medically attended local reactions to acellular pertussis vaccine. Pediatrics. 2011 Mar;127(3):e581-e587. Epub 2011 Feb 7. PubMed
Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants. PLoS One. 2011;6(6):e20102. Epub 2011 Jun 17. PubMed
Dublin S, Walker RL, Jackson ML, Nelson JC, Weiss NS, Jackson LA. Use of proton pump inhibitors and H2 blockers and risk of pneumonia in older adults: a population-based case-control study. Pharmacoepidemiol Drug Saf. 2010 Aug;19(8):792-802. Epub 2010 Jul 7. PubMed
Nelson JC, Bittner RC, Bounds L, Zhao S, Baggs J, Donahue JG, Hambidge SJ, Jacobsen SJ, Klein NP, Naleway AL, Zangwill KM, Jackson LA. Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: results from a Vaccine Safety Datalink study. Am J Public Health. 2009;99 Suppl 2:S389-97. 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.