Jennifer Clark Nelson, PhD

“As national statistical leaders, we promote the use of rigorous methods that enhance drug and vaccine safety monitoring in the United States.”

Jennifer Clark Nelson, PhD

Director, Biostatistics; Senior Investigator, Kaiser Permanente Washington Health Research Institute
Affiliate Professor of Biostatistics, University of Washington

Jen.Nelson@kp.org
206-287-2004

Curriculum vitae (CV)

Biography

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 electronic health care data.

Dr. Nelson provides national statistical leadership and strategic direction for the U.S. 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 safety research within the Centers for Disease Control and Prevention (CDC)-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving 13 health care organizations that has monitored immunization safety in the United States since 1990. Her CDC service further includes membership on the Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical Work Group to help inform recommendations on the use of these vaccines in the U.S.

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. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in vaccine safety. She is also a fellow of the American Statistical Association.

Research interests and experience

Biostatistics

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
Vaccines & Infectious Diseases

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
Medication Use & Patient Safety

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
Aging & Dementia

Biostatistics; statistical issues in longitudinal observational cohort studies
Cardiovascular Health

Recent publications

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

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

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.

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

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