Publications

Journal Articles

Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence - Biomedicines Journal March 2025

Article Archives

2024

The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals - PubMed November 2024

Emulations of Oncology Trials Using Real-World Data: A Systematic Literature Review - PubMed September 2024

Calibrating Observational Health Record Data Against a Randomized Trial - PubMed September 2024

2023

Advancing Health Equity: Efforts to Expand Education on Skin Lightening Products - Public Health Reports December 2023

Considerations for defining medication exposure when analyzing real-world data - Pharmacoepidemiology & Drug Safety March 2023

Generating evidence for racial and ethnic minorities during development of oncologic therapeutics - Regulatory Focus March 2023

Real-World Performance of SARS-Cov-2 Serology Tests in the United States, 2020 - PLoS ONE February 2023

2022

Using the IMEDS distributed database for epidemiological studies in type 2 diabetes mellitus - PubMed December 2022

The Aetion Coalition to Advancing Real-World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology - PubMed December 2022

Development and Evaluation of the Alogrithm CErtalnty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms' Fit for Purpose for Safety Outcomes - Drug Safety November 2022

The US Food and Drug Administration Sentinel System: a national resource for a learning health system - Journal of the American Medical Informatics Association September 2022

COVID-19 is associated with higher risk of venous thrombosis, but not arterial thrombosis, compared with influenza: Insights from a large US cohort - PLoS ONE January 2022

Sharing Health Data: The Why, the Will, and the Way Forward - A Special Publication from the National Academy of Medicine January 2022

2021

The use of narrative electronic prescribing instructions in pharmacoepidemiology: A scoping review for the International Society for Pharmacoepidemiology Pharmacoepidemiology & Drug Safety July 2021

Post-COVID-19 Syndrome: Leveraging the Patient Perspective and Technological Innovations to Enable the Delineation of Effective Treatments - Drugs June 2021

COVID-19 Vaccine Confidence Project  Journal of the American Pharmacists Association June 2021

OSE's annual report details Sentinel efforts during COVID pandemic - Regulatory Focus May 2021

COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients. PLoS ONE March 2021

2020

Characteristics Associated with Time-to-Treatment Initiation for Chronic Hepatitis C with New Direct Acting Antivirals - Pharmacoepidemiology & Drug Safety October 2020

FDA Applauds Role of Clinical Trials in Fighting COVID-19. Association of Clinical Research Professionals - Association of Clinical Research Professionals October 2020

Validity of an Automated Algorithm to Identify Cirrhosis Using Electronic Health Records in Patients with Primary Biliary Cholangitis - Clinical Epidemiology September 2020