Publications

Emulating RCTs by observational database studies: The RCT-DUPLICATE initiative in COPD and asthma
Samy Suissa, Sebastian Schneeweiss, William B Feldman, Helen Tesfaye, Shirley Wang
Am J Epi 2024 (in press)
Hypothetical Assessments of Trial Emulation
Sebastian Schneeweiss, MD, ScD; Shirley V. Wang, PhD
JAMA Intern Med. 2024 Apr 1;184(4):446. doi: 10.1001/jamainternmed.2023.7945. 
Strengthening Real-World Evidence on Question Not Answered by Randomized Trials: A Trial Calibration Approach. 
Julien Kirchgesner, Shirley V Wang, Sebastian Schneeweiss
Pharmacoepidemiol Drug Saf, 2024 Sep;33: e70008. doi:10.1002/pds.70008
Emulation of randomized trials of direct oral anticoagulants with claims data and implications for new Factor XI inhibitors.
Shirley V Wang, Kueiyu Joshua Lin, Sebastian Schneeweiss
Pharmacoepidemiol Drug Saf. 2024 May;33(5):e5813. doi: 10.1002/pds.5813.
Data Checks Before Registering Study Protocols for Health Care Database Analyses. 
Shirley V. Wang, PhD; Sebastian Schneeweiss, MD, ScD
JAMA. 2024 May 7;331(17):1445-1446. doi: 10.1001/jama.2024.2988.
Design differences explain variation in results between randomized trials and their non-randomized emulations. 
Rachel Heyard, Leonhard Held, Sebastian Schneeweiss, Shirley V Wang
BMJ Med. 2024 Feb 5;3(1):e000709. doi: 10.1101/2023.07.13.23292601. 
Real-World Evidence Prediction of a Phase IV Oncology Trial: Comparative Degarelix vs Leuprolide Safety.
David Merola, Sebastian Schneeweiss, Sushama K Sreedhara, Luke E Zabotka, Kenneth Quinto, John Concato, Shirley V Wang
JNCI Cancer Spectr. 2022 Aug 10;6(4):pkac049. doi: 10.1093/jncics/pkac049.
​Efficacy versus effectiveness: The HORIZON Pivotal Fracture Trial and its emulation in Claims Data.
Elvira D'Andrea, Sebastian Schneeweiss, Jessica M Franklin, Seoyoung C Kim, Robert J Glynn, Su Been Lee, Shirley V Wang
​Arthritis Rheumatol. 2024 Aug 11. doi: 10.1002/art.42968. 
​Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses: Results of 32 Clinical Trials.
Shirley V Wang, Sebastian Schneeweiss ; RCT-DUPLICATE Initiative
JAMA. 2023 Apr 25. doi: 10.1001/jama.2023.4221
Emulating Randomized Clinical Trials with Nonrandomized Real-World Evidence Studies: First Results from the RCT DUPLICATE Initiative. 
Jessica M. Franklin, Elisabetta Patorno, Rishi J. Desai, Robert J. Glynn, David Martin, Kenneth Quinto, Ajinkya Pawar, Lily G. Bessette, Hemin Lee, Elizabeth M. Garry, Nileesa Gautam, and Sebastian Schneeweiss
Circulation. 2020 Dec 17. doi: 10.1161/CIRCULATIONAHA.120.051718
Emulation Differences vs. Biases When Calibrating Real‐World Evidence Findings Against Randomized Controlled Trials.
Jessica M. Franklin, Robert J. Glynn, Samy Suissa, Sebastian Schneeweiss
Clinical Pharmacol Ther. 2020 Feb 12. doi: 10.1002/cpt.1793
Nonrandomized Real-World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project.
Jessica M. Franklin, Ajinkya Pawar, David Martin, Robert J. Glynn, Mark Levenson, Robert Temple and Sebastian Schneeweiss
​Clinical Pharmacol Ther. 2019 Sept 21. doi: 10.1002/cpt.1351.
Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making.
Jessica M. Franklin, Robert J Glynn, David Martin, Sebastian Schneeweiss
Clin Pharmacol Ther. 2019 Jan 13. doi: 10.1002/cpt.1351.
Use of Health Care Databases to Support Supplemental Indications of Approved Medications
Michael Fralick, MD; Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD; Sebastian Schneeweiss, MD, ScD JAMA Intern Med; 2018 Jan 1; 178(1):55-63
Synergies From Integrating Randomized Control Trials and Real-World Data Analyses 
Mehdi Najafzadeh, Joshua J. Gagne and Sebastian Schneeweiss Clin Pharmacol Ther 2017 Dec;102(6):914-916
When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials?
Franklin JM and Schneeweiss S. Clin Pharm & Ther 2017 Dec; 102(6): 924-933
Comparing the performance of Propensity Score Methods in Healthcare Database Studies with Rare Outcomes
Jessica M. Franklin, Wesley Eddings, Peter C. Austin, Elizabeth A. Stuart, and Sebastian Schneeweiss Stat Med 2017 May 30; 36 (12); 1946-1963
A Bias in the Evaluation of Bias Comparing Randomized Trials with Nonexpiramental Studies 
Jessica M. Franklin, Sara Dejene, Krista F Huybrechts, Shirley V Wang, Martin Kulldorff and Kenneth J Rothman Epidemiol Methods 2017 Apr 22;6(1)
From Trial to Target Populations — Calibrating Real-World Data
Mehdi Najafzadeh, Sebastian Schneeweiss N Engl J Med 376.13 (2017): 1203-5

​Improving Therapeutic Effectiveness and Safety Through Big Healthcare Data 
S Schneeweiss Clin Pharmacol Ther 2016 Feb 17; 99(3);262-5
​Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making
S Schneeweiss, H-G Eichler, A Garcia-Altes, C Chinn, A-V Eggimann, S Garner, W Goettsch, R Lim ,W Lobker,D Martin ,T Muller, BJ Park, R Platt, S Priddy, M Ruhl, A Spooner, B Vannieuwenhuyse and RJ Willke Clin Pharm and Ther 2016 Dec; 100(6):633-64
​Regularized Regression Versus the High-Dimensional Propensity Score for Confounding Adjustment in Secondary Database Analyses
Jessica M. Franklin, Wesley Eddings, Robert J. Glynn, and Sebastian Schneeweiss  Am J Epidemol 2015 Oct;182(7):651-9

A review of uses of health care utilization databases for epidemiologic research on therapeutics
Sebastian Schneeweiss, Jerry Avorn J Clin Epidemiol 2005 Apr; 58(4);323-37