Portrait of Esther J. Lu, PhD

Esther J. Lu, PhD

Professor of Surgery
Division of Public Health Sciences

Specialties

  • Biostatistics 
  • Financial Mathematics 
  • Computational Mathematics 
  • Study design in clinical trials
  • Implementation science 
  • Cluster randomized clinical trials 

Meet Dr. Lu 

Dr. Esther Lu is a biostatician specializing in computational and mathematical models for predicting risk. 

  • Dr. Lu provides statistical support at the Siteman Cancer Center (SCC) in the areas of Gastrointestinal, Gynecology, Head and Neck, and Thoracic diseases.
  • Dr. Lu helps designing case report forms (CRFs), builds the REDCap database, proposes data quality monitoring report, monitors data quality routinely during the trial, and prepares DSMB report, which functions as a data coordinating center. 
  • Dr. Lu supports the grant applications through helping study design, calculating sample size, and proposing study analysis methods, ensures that final data analyses are conducted rigorously, and assists in writing manuscripts describing research findings.
  • Dr. Lu’s primary research interests include study design in clinical trials and optimal designs in longitudinal studies and cluster randomized clinical trials (CRTs). Her research also includes change-point analysis, propensity score methodology, survival data analysis, statistical modeling and forecasting of clinical trial recruitment, and prediction models.
  • Dr. Lu earned a Master of science degree in financial mathematics from National University of Singapore. She then completed her training, earning her doctorate in biostatistics from Medical College of Wisconsin.  

Degrees

Bachelor of Science in Computational Mathematics
Nankai University, Tianjin, P.R. China
1997

 

Master of Science in Financial Mathematics
National University of Singapore, Singapore
2001

 

Doctorate in Biostatistics
Medical College of Wisconsin, Milwaukee, WI
2007

Research interests

  • Study design in clinical trials 
  • Optimal designs in clustered randomized trials (CRTs)
  • Relative efficiency in longitudinal studies and CRTs
  • Change-point analysis
  • Statistical modeling and forecasting of clinical trial recruitment
  • Prediction models
View research profile

Dr. Lu in the news

More information

Teaching Appointments

Master of Population Health Sciences (MPHS) degree program

  • M19-550 Randomized Controlled Trials

Professional Memberships

American Statistical Association

International Biometric Society

STS

Areas of Research Interest

Dr. Lu’s primary research interests include study design in clinical trials and optimal designs in longitudinal studies and cluster randomized clinical trials (CRTs). She specializes in clinical trial design applied in implementation science to propose optimal designs under budgetary constraint, which include longitudinal data, two-level/three-level parallel-arm clustered randomized trials (PA-CRTs), PA-longitudinal CRTs (PA-LCRTs), multiple-period cluster randomized crossover (CRXO) trials as well as stepped wedge CRTs (SW-CRTs). Her research also includes change-point analysis, propensity score methodology, survival data analysis, statistical modeling and forecasting of clinical trial recruitment, and prediction models.

As a lead statistician, she served on many projects during 2007-2009 including Phase I-IV clinical trials across different functional departments at the Pharmaceutical Product Development (PPD) Inc., which has ensured meeting the regulatory demands of FDA and submission deadlines of pharmaceutical companies. Since 2009, she has been a member of the Institute of Clinical and Translational Sciences (ICTS) Research Design and Biostatistics Group (RDBG) and is currently providing statistical support for the projects of the Siteman Cancer Center (SCC). At the SCC, she served as the statistician in the areas of Gastrointestinal, Gynecology, Head and Neck, and Thoracic diseases.

Selected Active Support Grants
R01CA258681
National Institutes of Health
Comparative Effectiveness of Surgery vs Stereotactic Radiation Therapy for Stage I Lung Cancer		Kozower/Puri/Robinson02/2022 – 01/2027
R01CA268030
National Institutes of Health
Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer
Screening and Smoking Cessation Treatment		Ramsey/Chen03/2022 – 02/2027
R01HD105855
National Institutes of Health
Subcontract with Women and Infants Hospital of Rhode Island
A Randomized Multicenter Trial of IV vs. Oral Iron for Treating Non-Deficiency Anemia in Pregnancy		Tuuli, Methodius06/2022 – 03/2027
R01DA056050
National Institutes of Health
A Multilevel Intervention to Personalize and Improve Tobacco Treatment and Primary		Chen/Ramsey08/2022 – 06/2027
P50CA265793
National Institutes of Health
Route 66 Endometral Cancer SPORE
Biostatistics and Bioinformatics Core Director (Esther Lu)		Mutch/Benbrook/Leslie08/23/2023 – 06/30/2028
P50CA272213
National Institutes of Health
Washington University SPORE in Pancreatic Cancer
Biostatistics and Bioinformatics Core Director (Esther Lu & Malachi Griffith)		Hawkins/DeNardo08/28/2023 – 06/30/2028
U54CA274318
National Institutes of Health
Washington University (WU) ROBIN Center: Microenvironment and Tumor Effects of Radiotherapy (METEOR)		Julie Schwarz09/01/2023 – 8/31/2028
U19CA291430 National Institutes of Health
Washington University ACCERT Center: Social Determinants of Health Research Project		Drake /Housten08/01/2024 – 07/31/2029
R01HD111426 National Institutes of Health           Subcontract with Women and Infants Hospital of Rhode Island       
A Randomized Trial of Chatbot for Prenatal Genetic Counseling		Tuuli/Russo09/2024 – 08/2029

Publications

Method
  • Optimal designs of longitudinal cluster randomized trials (LCRTs) including parallel-arm (PA)-LCRTs, multiple-period cluster randomized crossover (CRXO) trials and stepped wedge CRTs (SW-CRTs)
  1. Liu J, Li F, Luo Xuping, Chen Li-Shiun, Ramsey Alex. Optimal designs in open-cohort longitudinal cluster randomized trials with a continuous outcome. Biometrical Journal 2026
  2. Liu J, Li F, Siobhan Sutcliffe, Colditz GA. Selecting the optimal longitudinal cluster randomized design: parallel-arm, crossover or stepped-wedge. Statistical Methods in Medical Research 2025
  3. Liu J, Li F. Optimal designs using generalized estimating equation in cluster randomized crossover and stepped wedge trials. Statistical Methods in Medical Research 2024 Aug; 33(8):1299-1330
  • Optimal designs and relative efficiency of three-level PA-CRTs using generalized estimating equations (GEEs)
  1. LiuJ, LiuL, James AS, Colditz GA.An overview of optimal designs under a given budget in cluster randomized trials with a binary outcome. Statistical Methods in Medical Research 2023 Jul 32(7):1420-1441. PubMed PMID: 37284817
  2. LiuJ, Colditz GA.Sample size calculation in three-level cluster randomized trials using generalized estimating equation models. Statistics in Medicine 2020, 39(24): 3347-3372
  3. LiuJ, LiuL, Colditz GA.Optimal designs in three-level cluster randomized trials with a binary outcome. Statistics in Medicine 2019; 38:3733-3746.
  • Optimal designs and relative efficiency of longitudinal data and two-level parallel-arm clustered randomized trials (PA-CRTs) using GEEs
  1. Liu J, XiongC, LiuL, WangG, LuoJ, GaoF, ChenL, LiY. Relative efficiency of unequal versus equal cluster sizes in cluster-randomized trials using bias-corrected sandwich estimators. Journal of Biopharmaceutical Statistics2021 Mar; 31(2):191-206.
  2. Liu J, Colditz GA. Relative efficiency of unequal versus equal cluster sizes in cluster randomized trials using generalized estimating equation models. Biometrical Journal 2018, 60(3):616-38
  3. Liu J, Colditz GA. Optimal design of longitudinal data analysis using generalized estimating equation models. Biometrical Journal 2017; 59(2):315-30. PMID: 27878852
Application

Clinical trials

  1. Campian JL, Le SB, Ghiaseddin A, Butt OH, Manektalia H, Chen D, Xu Y, Liu J, Rahman M, Thai N, Leidig WA, Johanns T, Ansstas G, Zhou AY, Pugazenthi S, Dunn GP, Huang J, Chheda MG, Kim AH, Leuthardt EC, Tran DD. Laser interstitial thermal therapy and adjuvant pembrolizumab in recurrent high-grade astrocytoma: a Phase 1/randomized Phase 2b trial. Nature Communications
  2. Grierson P, Wolf C, Suresh R, Wang-Gillam A, Tan B, Pedersen K, Ratner L, Oppelt P, Aranha O, Frith A, Baer J, DeNardo D, Boice N, Brown A, Xu Y, Liu J, Lim KH. Neoadjuvant BMS-813160, nivolumab, gemcitabine and nab-paclitaxel for pancreatic cancer. Clinical Cancer Research 2025 Sep 2;31(17):3644-3651. PMCID: PMC12402776.
  3. Adkins D, Ley JC, Liu J, Oppelt P. Ramucirumab in combination with pembrolizumab for recurrent or metastatic head and neck squamous-cell carcinoma: a phase 1-2 trial. Lancet Oncology 2024 Jul;25(7):888-900. PMCID: PMC12571033.
  4. Tuuli MG, Liu J, Tita ATN, Longo S, Trudell A, Carter E, Shanks A, Woolfolk C, Caughey AB, Warren D, Odibo A, Colditz G, Macones GA, Harper L. Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial. Journal of the American Medical Association 2020; 324(12):1180-1189
  5. Cahill AG, Srinivas SK, Tita A, Caughey AB, Richter H, Gregory T, Liu J, Woolfork C, Weinstein D, Mathur A, Macones GA, Tuuli MG. Effect of immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery among Nulliparous Women Receiving Neuraxial Analgesia: A Multicenter Randomized Trial. Journal of the American Medical Association 2018 Oct 9; 320(14):1444-1454. PubMed PMID: 30304425
  6. Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A randomized trial comparing skin antiseptic agents at cesarean delivery. New England Journal of Medicine 2016 Feb 18; 374 (7):647-55. PMID: 26844840.
  7. Rock CL, Flatt SW, Byers TE, Colditz GA, Demark-Wahnefried W, Ganz PA, Wolin KY, Elias A, Krontiras H, Liu J, Naughton M, Pakiz B, Parker BA, Sedjo RL, Wyatt H, for the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial Group. Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors. Journal of Clinical Oncology, 2015, 33(28):3169-76.

Implementation science

  1. Newland JG, Liu J, Malone S, Sattler M, Saito J, Rangel SJ, Tao J, Bono K, Atkinson A, Tetteh E, McKay VR. Eliminating Inappropriate Postoperative Antibiotics: A Stepped-Wedge Cluster Randomized Trial. Pediatrics
  2. Cooksey K, Goldstein EC, Lee CN, Mozersky J, Kaphingst KA, Liu J, Wu S, Volkmar M, Catalan-Gallegos V, Politi MC. Implementing and evaluating visual key information pages compared to text-based key information: Protocol for a stepped-wedge cluster randomized trial. BMC Medical Ethics 2026
  3. McKay V, Malone S, Tetteh E, Saito J, Rangel S, Bono K, Tao J, Liu J, Obeng H, Atkinson A, Newland JG. Facilitation as an effective strategy to reduce excessive antibiotic prophylaxis in Children’s hospitals: A stepped-wedge cluster randomized controlled trial. Implement Sci. 2025 Oct 21;20(1):45. doi: 10.1186/s13012-025-01455-2. PMCID: PMC12542473.
  4. Malone M, Bono K, Saito JM, Rangel S, Liu J; Newland, JG, McKay V. Evaluating a virtual facilitation workshop with antimicrobial stewardship teams within a cluster randomized stepped-wedge trial. BMC Health Services Research, 2024 Oct 21;24(1):1263. PMCID: PMC11492772.
  5. Hayes S, Malone S, Bonty B, Mueller N, Reyes SM, Reyes SA, Evans C, Roberts MW, Watterson T, Akuse S, Shelley J, Yuan G, Lackey I, Prater J, Montgomery B, Williams C, Butler-Barnes ST, Harris K, Caburnay C, Dougherty NL, Liu J, Lai A; Neidich J; Fritz S; Newland JG. Assessing COVID-19 testing strategies in K-12 schools in underserved populations: study protocol for a cluster-randomized trial. BMC Public Health 2022 Jun 13; 22(1). PubMed PMCID: PMC9189793.
  6. Malone S, McKay VR, Krucylak C, Powell BJ, Liu J, Terrill C, Saito JM, Rangel SJ, Newland JG. A cluster randomized stepped-wedge trial to de-implement unnecessary post-operative antibiotics in children: the optimizing perioperative antibiotic in children (OPerAtiC) trial. Implement Sci. 2021 Mar 19; 16(1):29. PubMed PMCID: PMC7980649.
  7. Salazar AS, Sekhon S, Rohatgi KW, Nuako A, Liu J, Harriss C, Brennan E, LaBeau D, Abdalla I, Schulze C, Muenks J, Overlot D, Higgins JA, Jones LS, Swick C, Goings S, Badiu J, Walker J, Colditz GA, James AS. A Stepped-Wedge Randomized Trial Protocol of a Community Intervention for Increasing Lung Screening Through Engaging Primary Care Providers (I-STEP). Contemporary Clinical Trials 2020 Apr; 91:105991. pub 2020 Mar 14.

    Observational studies

    1. Dolatshahi M, Commean PK, Rahmani F, Xu Y, Liu J, Kassani SH, Naghashzadeh M, Lloyd L, Nguyen C, Kemper AM, Hantler N, Ly M, Yu G, Flores S, Ippolito JE, Song S, Sirlin C, Morris JC, Benzinger TL, Raji CA. Relationships between Abdominal Adipose Tissue and Neuroinflammation with Diffusion Basis Spectrum Imaging in Midlife Obesity. Obesity 2025 Jan;33(1):41-53. PMCID: PMC11664304.
    2. Wang Q, Schindler S, Chen G, McKay NS, McCullough A, Flores S, Liu J, Sun Z, Wang S, Wang W, Hassenstab J, Cruchaga C, Perrin R, Fagan A, Morris J, Wang Y, Benzinger TL. Investigating white matter neuroinflammation in Alzheimer Disease using diffusion-based neuroinflammation imaging. Neurology 2024 Feb;102(4):e208013. PMCID: PMC10890836.
    3. Chi S, Kim S, Reuter M, Ponzillo K, Oliver DP, Foraker R, HeardK, Liu J, Pitzer K, White P, Moore N.  Advanced Care Planning for Hospitalized Patients Following Clinician Notification of Patient Mortality by a Machine Learning Algorithm. JAMA Network Open 2023 Apr 3;6(4): e238795.  PMCID: PMC10114011.
    4. Heiden BT, Subramanian MP, Liu J, Keith A, Engelhardt KE, Meyers BF, Puri V, MD, Kozower BD. Long-Term Patient-Reported Outcomes Following Non-Small Cell Lung Cancer Resection. Journal of Thoracic and Cardiovascular Surgery 2022 Mar 12. PubMed PMID: 35430080.
    5. Takahashi T, Terada Y, Pasque MK, Liu J, Byers DE, Witt CA, Nava RG, Puri V, Kozower BD, Meyers BF, Kreisel D, Patterson GA, Hachem RR. Clinical Features and Outcomes of Combined Pulmonary Fibrosis and Emphysema After Lung Transplantation. Chest. 2021 Nov; 160(5):1743-1750. PubMed PMCID: PMC8628179.
    6. Gay HA*, Liu J* (Co-first authors), Spencer CR, Lewis JS, Diaz J, Nussenbaum B, Piccirillo JF, Ferraro DJ, Wildes TM, Sinha P, Adkins DR, Haughey BH, and Thorstad WL. Outcomes of p16 positive oropharyngeal squamous cell carcinoma treated with surgery and adjuvant IMRT. Journal of Radiation Oncology, 2015: 4(1): 37-46.
    7. Carson KR, Bartlett NL, McDonald JR, Luo S, Zeringuie A, Liu J, Fu J, Chang S-H, Colditz GA. Increased Body Mass Index is associated with improved survival in United States veterans with diffuse large B-cell lymphoma. Journal of Clinical Oncology 2012; 30(26): 3217-3222.

    List of Published Work (with PMCID):

    Publications by Dr. Lu on PubMed