Innovations
Peer-reviewed publications, award-winning methodology, and real-world evidence that advances healthcare research.
Awards & Grants
2025
GenZ-trials: Revolutionizing Clinical Trials to Optimize Assessment of Healthcare Innovations
Winner of 5-year research grant GenZ-trials to lead the integration of Digital Twins and Synthetic Control Arms for protocol optimization through in-silico simulation, enabling ethically sound alternatives to placebo groups using real-world data to construct robust comparators with fewer enrolled participants.
Learn More2018
Global Scrip® Award — Best Use of Real-World Evidence, London
The Scrip Awards recognized RWE expertise with its inaugural award for “Best Use of Real-World Evidence.” The winning project aimed to overcome challenges faced when using real-world healthcare data to identify patients with specific subtypes of Multiple Sclerosis, identify high disease activity, evaluate disability by ICD-based EDSS/KFSS, and characterize relapse events, via validated algorithms.
2009
SafetyWorks® Innovation Award — Best Practices, Bio-IT World
Awarded for developing and validating the web-based application to detect and assess drug safety signals — winner of the Best Practices Award of the Bio-IT World, Boston.
Real-World Synthetic Control Arms in Action
Journal: Leukemia & Lymphoma (2023)
Study: Comparison of lisocabtagene maraleucel vs. conventional therapy in relapsed/refractory large B-cell lymphoma using a real-world synthetic control arm
Authors: Le HV, Van Naarden Braun K, Nowakowski GS, et al.
Significance: Demonstrated successful application of synthetic control arms for direct therapeutic comparison in a high-stakes oncology setting. This ECA was used as a case study in the EMA 2025 Workshop.
External Control Arms & Digital Twins
KarMMa-RW: comparison of idecabtagene vicleucel with real-world outcomes in relapsed and refractory multiple myeloma
This ECA was used as a case study in the EMA 2025 Workshop
Comparison of lisocabtagene maraleucel vs. conventional therapy in relapsed/refractory large B-cell lymphoma using a real-world synthetic control arm
This ECA was used as a case study #3 in the EMA 2025 Workshop
GenZ-trials: Revolutionizing Clinical Trials to Optimize Assessment of Healthcare Innovations
Effect of designations of index date in externally controlled trials: an empirical example
Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic or Unresectable EGFR-Mutated Non-Small Cell Lung Cancer Previously Treated with Osimertinib and Platinum-Based Chemotherapy
Patel J, Meng J, Le HV, et al.
DOI: 10.1007/s12325-024-02936-4Algorithm Development & Validation
Identifying relapsing-remitting multiple sclerosis (RRMS) in United States integrated delivery network healthcare claims and electronic health record (EHR) data
Le HV, Truong C, Kamauu A, et al.
DOI: 10.1016/j.jval.2018.06.014Creating a Real-World Data, United States Healthcare Claims-Based Adaptation of Kurtzke Functional Systems Scores for Assessing Multiple Sclerosis Severity and Progression
Effects of Aggregation of Drug and Diagnostic Codes on the Performance of the High Dimensional Propensity Score Algorithm: An Empirical Example
Le HV, Poole C, Brookhart AM, et al.
DOI: 10.1186/1471-2288-13-142Data Labeling & Annotation for AI & RWE
Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts
Pierce CE, Bouri K, Pamer C, et al.
DOI: 10.1007/s40264-016-0491-0Identification of responders to inhaled corticosteroids in a COPD population using cluster analysis
Hinds DR, DiSantostefano RL, Le HV, et al.
DOI: 10.1136/bmjopen-2015-010099Performances of the Deep Learning Approach to Nonparametric Propensity Score Estimation with Optimized Covariate Balance in Small Samples
Le HV, et al.
2025
Study Design, Analytics & Scientific Communication
Real-World Treatment Patterns and Clinical Outcomes in Patients With Extensive-Stage Small Cell Lung Cancer Treated With First-Line Platinum-Based Chemotherapy and ≥ 2 Subsequent Lines of Therapy in the United States
Sankar K, Unni S, Eberl M, et al.
DOI: 10.1007/s12325-025-03408-zPerformance of a semi-automated approach for risk estimation using a common data model for longitudinal healthcare databases
Le HV, Beach JK, Powell G, et al.
DOI: 10.1177/0962280211403599Hospital Admission Patterns in Adult Patients with Community-Acquired Pneumonia Who Received Ceftriaxone and a Macrolide by Disease Severity across United States Hospitals
Lodise PT, Le HV, LaPensee K.
DOI: 10.3390/antibiotics9090577Medical Coding & Phenotype Definition
Risk of pneumonia with inhaled corticosteroid versus long-acting bronchodilator regimens in chronic obstructive pulmonary disease: a new-user cohort study
Can assessment of disease burden prior to changes in initial COPD maintenance treatment provide insight into remaining unmet needs? A retrospective database study in UK primary care
Landis S, Wurst K, Le HV, et al.
DOI: 10.1080/15412555.2016.1240159Patient characteristics and treatment patterns over 24 months among COPD patients initiating long-acting bronchodilator prescription in the UK primary care setting
Punekar YS, Landis S, Wurst K, et al.
DOI: 10.1186/s12931-015-0295-2The Relationship Between Blood Eosinophils and Clinical Characteristics in a Cross-Sectional Study of a US Population-Based COPD Cohort
DiSantostefano RL, Le HV, Hinds, et al.
DOI: 10.1016/j.rmed.2016.01.013