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.
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
Nelson JC, Ulloa-Pe'rez E, Bobb JF, Maro JC. Leveraging the entire cohort in drug safety monitoring: part 1: methods for sequential surveillance that use regression adjustment or weighting to control confounding in a multi-site, rare event, distributed data setting. J Clin Epidemiol. 2019 May 17. pii: S0895-4356(17)30857-0. doi: 10.1016/j.jclinepi.2019.04.012. [Epub ahead of print]. PubMed
Cook AJ, Wellman RD, Marsh T, Shoaibi A, Tiwari R, Nguyen M, Boudreau D, Weintraub ES, Jackson L, Nelson JC. Applying sequential surveillance methods that use regression adjustment or weighting to control confounding in a multi-site, rare event, distributed setting: part 2:in-depth example of a re-analysis of the measles-mumps-rubella-varicella combination vacc J Clin Epidemiol. 2019 Sep; 113:114-122. PubMed
Shortreed SM, Cook AJ, Coley RY, Bobb JF, Nelson JC. Challenges and opportunities for using big health care data to advance medical science and public health. Am J Epidemiol. 2019 May 1;188(5):851-861. doi: 10.1093/aje/kwy292. PubMed
McClure JB, Anderson ML, Krakauer C, Blasi P, Bush T, Nelson J, Catz SL. Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial. Transl Behav Med. 2019 Feb 12. pii: 5316179. doi: 10.1093/tbm/ibz009. [Epub ahead of print]. PubMed
Blasi PR, Krakauer C, Anderson ML, Nelson J, Bush T, Catz SL, McClure JB. Factors associated with future dental care utilization among low-income smokers overdue for dental visits. BMC Oral Health. 2018 Nov 1;18(1):183. doi: 10.1186/s12903-018-0646-8. PubMed
Jackson ML, Yu O, Nelson JC, Nordin JD, Tartof SY, Klein NP, Donahue JG, Irving SA, Glanz JM, McNeil MM, Jackson LA. Safety of repeated doses of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine in adults and adolescents. Pharmacoepidemiol Drug Saf. 2018 Aug;27(8):921-925. doi: 10.1002/pds.4569. Epub 2018 Jun 3. PubMed
Tseng HF, Sy L, Qian L, Liu IA, Mercado C, Lewin B, Tartof SY, Nelson JC, Jackson LA, Daley MF, Weintraub E, Klein NP, Belongia E, Liles EG, Jacobsen SJ. Pneumococcal conjugate vaccine safety in elderly adults. Open Forum Infectious Diseases, Volume 5, Issue 6, 1 June 2018, ofy100, https://doi.org/10.1093/ofid/ofy100.
McClure JB, Bush T, Anderson ML, Blasi P, Thompson E, Nelson J, Catz SL. Oral Health Promotion and Smoking Cessation Program Delivered via Tobacco Quitlines: The Oral Health 4 Life Trial. Am J Public Health. 2018;108(5):689-695. doi: 10.2105/AJPH.2017.304279. Epub 2018 Mar 22. PubMed
Martin D, Gagne JJ, Gruber S, Izem R, Nelson JC, Nguyen MD, Ouellet-Hellstrom R, Schneeweiss S, Toh S, Walker AM. Sequential surveillance for drug safety in a regulatory environment. Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):707-712. doi: 10.1002/pds.4407. Epub 2018 Mar 5. No abstract available. PubMed
Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, Carnahan RM. Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System. Pharmacoepidemiol Drug Saf. 2018 Jan 10. doi: 10.1002/pds.4375. [Epub ahead of print]. PubMed
KPWHRI researchers analyzed data from more than 640,000 vaccine doses to understand risk of severe reactions.
New study supports a growing body of data that shows the vaccines are safe during pregnancy.
Honors from the Health Care Systems Research Network for early career achievements and manuscript of the year
Jen Nelson, PhD, talks about monitoring reactions to the mRNA vaccines.