Publications

Our research library includes a focus on pharmacoepidemiology and real-world evidence analysis to support safety and effectiveness research

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Publication

Postmarketing safety surveillance for GSK's AS01ᴇ-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study.

March 19, 2026
Authors:

Adimadhyam S,  Luyts D, Oraichi D, Deraedt Q, Pircon JY, Bilker WB, Agan AA, Rajbhandari R,  Carbonari DM, Djibo DA, Wang X, Nolan MB, DeVries A, Selvan M, Ma Q, Wentz  AE, Daniels K, Platt R, Lo Re V 3rd, Cocoros NM

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
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RWE Research & Consulting
Publication

Interim Safety of RSVpreF Vaccination During Pregnancy

February 3, 2026
Authors:

Michnick AI, MacDonald SC, Cosgrove A, Adimadhyam S, Zhang F, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Maro JC, Platt R, Andrade SE

Capabilities:
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Pregnancy & Mother-Infant Linked Studies
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Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
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RWE Research & Consulting
Publication

Post-authorization Safety Study to Assess the Risk of Diabetic Ketoacidosis among Type 2 Diabetes Mellitus Patients Treated with Ertugliflozin Compared to Patients Treated with Other Antihyperglycemic Agents in a Medicare and Medicaid Population

December 15, 2025
Authors:

Rai A, Marshall J, Nandyala S, Her M, Agan AA, Huang TY, Rodriguez-Watson C, Clary A, Diessner B, Nolan MB, Djibo DA, DeVries A, Daniels K, Zhang X, Wang T, Gantz I, Shankar R, Zale MM, Ejelonu P, Frederich R, Masiukiewicz U, Toh S

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
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RWE Research & Consulting
Conference Abstract

Post-authorization Safety Study to Assess the Risk of Diabetic Ketoacidosis among Type 2 Diabetes Mellitus Patients Treated with Ertugliflozin Compared to Patients Treated with Other Antihyperglycemic Agents

August 22, 2025
Authors:

Rai A, Marshall J, Nandyala S, Her M, Agan AA, Huang TY, Rodriguez-Watson C, Clary A, Diessner B, Nolan M, Djibo DA, DeVries A, Daniels K, Zhang X, Wang T, Gantz I, Shankar R, Zale MM, Ejelonu P, Toh S

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Rapid Surveillance Study to Evaluate Safety of Respiratory Syncytial Virus (RSV) Vaccine (ABRYSVO) Exposure During Pregnancy in the United States

August 22, 2025
Authors:

MacDonald SC, Gandhi S, Adimadhyam S, Albert S, Anastasiou O, Andrade SE, Back S, Cosgrove A, Djibo DA, Koram N, Kuntz JL, Lino M, Love S, McElroy NP, McMahillWalraven CN, Michnick AI, Palmsten K, Petrone AB, Platt R, Round KE, Rubino H, Wentz AE, Zhang F, Maro JC

Capabilities:
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Pregnancy & Mother-Infant Linked Studies
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Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting
Publication

Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA

August 7, 2025
Authors:

Mayer SE, Kluberg SA, Spence O, Oraichi D, Seifert H, Ali O, Yun H, Simon AL, Ko JS, Hugh C, Her M, Shattuck K, Jamal-Allial A, Djibo DA, Daniels K, Ma Q, McMahill-Walraven CN, Ogilvie RP, Palmsten K, Selvan M, Ziyadeh N, Ogdie A, George MD

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
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RWE Research & Consulting
Conference Abstract

Risk of Incident Supraventricular Tachycardia Following Exposure to Recombinant Zoster Vaccine in Adults >50 Years of Age in the United States

August 1, 2025
Authors:

Mayer SE, Alam S, Peters A, MessengerJones E, Li D, Platt R, Suleiman B, Granger CB, Moyneur E, Ma Q, Selvan M, Ogilvie RP, Ziyadeh NJ, Daniels K, Wentz A, Djibo DA, McMahillWalraven CN, Oraichi D, Seifert H, Franck V, Yun H, Spence Omareen, Kluberg SA

Capabilities:
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Validation Studies & Algorithm Development
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
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RWE Research & Consulting
Conference Abstract

Incidence Rates of Safety Events of Interest in a Post-Approval Study of Original Pfizer-BioNTech Monovalent COVID-19 Vaccine in the United States: Primary series analysis

August 1, 2025
Authors:

Kawai A, Fuller C, Koram N, Agan AA, Brown J, Burk J, Cai B, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeVries A, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB, Layton JB, Love S, Ma Q, Mayer SE, McMahillWalraven CN, Moyneur E, Nolan M, Rao S, Reynolds JS, Selvan M, Vetter J, Wang X, Wideman K, Zhao Y, Ziyadeh NJ, Platt R, Gilsenan A

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Baseline Characteristics of Patients Included in a Post-Approval Safety Study of Pfizer-BioNTech Monovalent COVID-19 Vaccine in the United States: Results From an Interim Analysis

August 1, 2025
Authors:

Rao S, Fuller CC, Koram N, Agan AA, Brown J, Burk J, Cai B, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeVries A, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB, Kawai A, Layton JB, Love S, Ma Q, Mayer SE, McMahillWalraven CN, Moyneur E, Nolan M, Reynolds JS, Selvan M, Vetter J, Wang X, Wideman K, Zhao Y, Ziyadeh NJ, Platt R, Gilsenan A

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Incidence rates of safety outcomes in a post-approval study of the Pfizer-BioNTech monovalent COVID-19 vaccine in the United States, booster dose analysis

August 1, 2025
Authors:

Hawrusik R, Kawai A, Koram N, Agan AA, Avula R, Brown J, Burk J, Cai B, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeFor T, DeVries A, Diessner B, Djibo DA, Ezzy S, Johannes CB, Layton JB, Love S, Mayer S, Ma Q, Moyneur E, Nolan MB, Platt R, Rao S, Reynolds JS, Selvan M, Sharma V, McMahillWalraven CN, Vetter J, Ziyadeh NJ, Gilsenan A, Fuller CC

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Incidence Rates of Myocarditis/Pericarditis after Pfizer-BioNTech COVID-19 Vaccine in the United States: Interim Results From a Postapproval Safety Study, Primary Series Analysis

August 1, 2025
Authors:

Fuller CC, Kawai A, Hawrusik R, Koram N, Agan AA, Avula R, Brown J, Burk J, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeFor T, DeVries A, Diessner B, Djibo DA, Ezzy S, Johannes CB, Cai B, Layton JB, Love S, Mayer S, Ma Q, Moyneur E, Nolan MB, Rao S, Reynolds JS, Selvan M, Sharma V, McMahillWalraven CN, Vetter J, Ziyadeh NJ, Gilsenan A, Platt R

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Quantitative Bias Analysis to Assess the Impact of Outcome Misclassification in a US Claims-based COVID-19 Vaccine Safety Study

August 1, 2025
Authors:

Mayer SE, Layton JB, Praet N, Haynes K, Alam SM, Bell EJ, Brown J, Coughlin K, Daniels K, Dea K, DeVries A, Diessner BJ, Djibo DA, Horgan CE, Love S, Ma Q, McMahillWalraven CN, Moyneur É, Platt R, Reynolds JS, Selvan M, Yost E, Zhao Y, Ziyadeh NJ, Fuller CC, Gilsenan A

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
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Regulatory Research & Support
,
RWE Research & Consulting
Protocol

Epidemiology of Guillain-Barré Syndrome and Risk Associated with Exposure to ABRYSVO Among Vaccinees 18-59 Years of Age in the United States

June 27, 2025
Authors:

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, HealthPartners Institute,  Kaiser Permanente Southern California, Pfizer, Inc.

Capabilities:
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Validation Studies & Algorithm Development
,
Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Rapid Surveillance Safety Study of RSV Vaccine (ABRYSVO) Exposure During Pregnancy

June 24, 2025
Authors:

MacDonald SC, Gandhi S, Adimadhyam S, Albert S, Anastasiou O, Andrade SE, Back S, Cosgrove A, Djibo DA, Koram N, Kuntz JL, Lino M, Love S, McElroy NP, McMahillWalraven CN, Michnick AI, Palmsten K, Petrone A, Platt R, Round KE, Rubino H, Wentz A, Zhang F, Maro JC

Capabilities:
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Pregnancy & Mother-Infant Linked Studies
,
Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Using validated algorithms to estimate annual Lyme disease incidence in the United States, 2016-2023

May 29, 2025
Authors:

Kluberg SA, Cocoros NM, Oneill J, Shapiro K, Rosen E, Jin R, Aucott J, Daniels K, Love S, Djibo DA, Selvan M, DeVries A, Ma Q, Stark JH, Mo'si JC, Willis SJ

Capabilities:
,
Validation Studies & Algorithm Development
Expertises:
,
RWE Research & Consulting
Conference Abstract

Rapid Surveillance Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (Abrysvo™) Exposure During Pregnancy in the United States

May 26, 2025
Authors:

MacDonald SC, Gandhi S, Adimadhyam S, Albert S, Anastasiou O, Andrade SE, Back S, Cosgrove A, Djibo DA, Koram N, Kuntz JL, Lino M, Love S, McElroy NP, McMahillWalraven CN, Michnick AI, Palmsten K, Petrone A, Platt R, Round KE, Rubino H, Wentz A, Zhang F, Maro JC

Capabilities:
,
Pregnancy & Mother-Infant Linked Studies
,
Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting
Protocol

A post-marketing active surveillance study to evaluate the risk of Guillain-Barré syndrome, acute disseminated encephalomyelitis, and atrial fibrillation in adults 50 years and older vaccinated with GSK’s Arexvy vaccine in the United States

March 6, 2025
Authors:

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, Humana HealthCare, HealthPartners Institute, GlaxoSmithKline

Capabilities:
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Validation Studies & Algorithm Development
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Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting
Publication

Validation of algorithms to detect acute and disseminated Lyme disease in U.S. administrative claims data

February 20, 2025
Authors:

Kluberg SA, Cocoros NM, O'Neill J, Boyce TG, Sundaram ME, Schotthoefer A, Greenlee RT, Djibo DA, McMahill-Walraven CN, Aucott J, Moïsi JC, Jodar L, Willis SJ, Stark JH

Capabilities:
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Validation Studies & Algorithm Development
Expertises:
,
RWE Research & Consulting
Publication

Patient characteristics and use for bevacizumab in ophthalmology and oncology in a distributed research network

February 6, 2025
Authors:

Ko JS, Mendelsohn AB, Daniels K, Gomez-Lumbreras A, Marshall J, McDermott C, Pawloski PA, Yee GC, Lockhart CM

Expertises:
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RWE Research & Consulting
Protocol

A Non-Interventional Post-Authorization Safety Study of Pfizer-BioNTech Bivalent COVID-19 Vaccine in the United States

September 23, 2024
Authors:

Harvard Pilgrim Health Care Institute, RTI Health Solutions, CVS Health, Carelon Research, HealthPartners Institute, Humana HealthCare Research, Optum Epidemiology, Pfizer, Inc.

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting