Publications

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

Explore Harvard Pilgrim Health Care Institute's Work on PubMed
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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:
,
Validation Studies & Algorithm Development
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

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

41st Annual International Society for Pharmacoepidemiology Conference
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:
,
Pregnancy & Mother-Infant Linked Studies
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Using Validated Algorithms to Estimate Annual Lyme Disease Incidence in the United States, 2016-2023

17th International Conference on Lyme Borreliosis and Tick-Borne Diseases
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
Expertise:
,
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

43rd Annual Meeting of European Society for Pediatric Infectious Diseases
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
Expertise:
,
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:
,
Validation Studies & Algorithm Development
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Publication

Validation of Algorithms to Detect Acute and Disseminated Lyme Disease in U.S. Administrative Claims Data

Open Forum Infectious Diseases
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:
,
Validation Studies & Algorithm Development
Expertise:
,
RWE Research & Consulting
Publication

Patient Characteristics and Use for Bevacizumab in Ophthalmology and Oncology in a Distributed Research Network

Journal of Managed Care and Specialty Pharmacy
February 6, 2025
Authors:

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

‍

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

Background Rates of Neuroinflammatory Disorders and Atrial Fibrillation - Conditions of Interest for Vaccine Safety Studies

40th Annual International Society for Pharmacoepidemiology Conference
August 24, 2024
Authors:

Agan A, Horgan C, Adimadhyam S, Lo Re V, Luyts D, Deraedt Q, Omole A, Corocos N

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

Pregnancy Exposures and Outcomes in Women with Inflammatory Bowel Disease Treated with Risankizumab: A Cohort Study Utilizing Large Electronic Healthcare Databases with Mother-Baby Linkage in the United States

August 6, 2024
Authors:

Harvard Pilgrim Health Care Institute, Reagan-Udall Foundation for FDA, CVS Health, Carelon Research, Humana HealthCare Research, Health Partners Institute, AbbVie

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

Interim Utilization Results from a Post Approval Safety Study of Pfizer BioNTech Monovalent COVID 19 Vaccine in the United States

40th Annual International Society for Pharmacoepidemiology Conference
August 1, 2024
Authors:

Mayer SE, Kawai A, Fuller CC, Agan AA, Rao S, Koram N, Calingaert B, Marshall J, Connolly JG, Moyneur E, Allial AJ, Brown J, Burk J, Chomistek A, Daniels K, Dea K, DeFor T, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB, Kendrick K, Layton JB, Ma Q, Mai X, Mack M, Pawloski PA, Reynolds JS, Selvan M, Sharma V, Vetter J, McMahill-Walraven CN, Platt R, Gilsenan A

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

Risk of Incident Gout Following Exposure to Recombinant Zoster Vaccine in US Adults Aged ≥50 Years

Seminars in Arthritis and Rheumatism
July 14, 2024
Authors:

Kluberg SA, Simon AL, Alam SM, Peters A, Horgan C, Li D, Moyneur E, Messenger-Jones E, Platt R, McMahill-Walraven CN, Djibo DA, Daniels K, Jamal-Allial A, Pernar CH, Ziyadeh NJ, Ma Q, Selvan M, Spence O, Oraichi D, Seifert H, Franck V, Gamble S, Yun H

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

Effectiveness and Safety of the Recombinant Zoster Vaccine in Patients >18 Years of Age with Systemic Lupus Erythematosus or Multiple Sclerosis

American College of Rheumatology Convergence 2024
June 17, 2024
Authors:

Kluberg SA, Mayer SE, Spence Omareen, Oraichi D, Seifert H, Ali O, Yun H, Simon AL, Ko JS, Hugh C, Her M, Shattuck K, Platt R, Allial AJ, Djibo DA, Daniels K, Ma Q, McMahillWalraven CN, Ogilvie RP, Palmsten K, Selvan M, Ziyadeh N, Ogdie A, George M

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

Utilization and Patient Characteristics for the Trastuzumab Reference and Biosimilars, and Other HER2 Inhibitors in the United States

Journal of Managed Care Pharmacy
May 29, 2024
Authors:

Mai X, Mendelsohn AB, Marshall J, Lin ND, McDermott CL, Ko JS, Pawloski PA, Jamal-Allial A, Daniels K, McMahill-Walraven CN, Djibo DA, Lockhart CM

Expertise:
,
RWE Research & Consulting
Protocol

A Rapid Surveillance and Cohort Post-Marketing Safety Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy in the United States

May 2, 2024
Authors:

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

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

A Post-Authorization Safety Study to Evaluate the Safety of Abrocitinib Exposure During Pregnancy in United States Healthcare Databases

April 4, 2024
Authors:

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, HealthPartners Institute, Humana HealthCare Research, Pfizer, Inc.

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

Risk of Incident Gout Following Exposure to Recombinant Zoster Vaccine in Adults Aged >50 Years in the United States

American College of Rheumatology Convergence 2023
November 10, 2023
Authors:

Kluberg SA, Simon AL, Alam S, Peters A, Horgan CE, Li D, Moyneur E, Platt R, McMahill-Walraven CN, Djibo DA, Ma Q, Selvan M, Pernar CH, Ziyadeh NJ, Jamal-Allial AJ, Daniels K, Spence O, Oraichi D, Seifert H, Franck V, Gamble S, Yun H

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

Extending an Under-Recognized Burden of Lyme Disease with Administrative Claims Data

International Symposium on Tick-borne Pathogens and Disease 2023
October 22, 2023
Authors:

Kluberg SA, Cocoros NM, Rosen E, Jin R, Aucott JN, Pugh SJ, Stark JH

Capabilities:
,
Validation Studies & Algorithm Development
Expertise:
,
RWE Research & Consulting
Protocol

Safety and Effectiveness of RZV in Adults ≥18 Years of Age with Systemic Lupus Erythematosus (SLE) or Multiple Sclerosis (MS)

October 18, 2023
Authors:

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

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

Validation of Claims-Based Algorithm for Lyme Disease, Massachusetts, USA

Emerging Infectious Diseases
September 1, 2023
Authors:

Cocoros NM, Kluberg SA, Willis SJ, Forrow S, Gessner BD, Nutt CT, Cane A, Petrou N, Sury M, Rhee C, Jodar L, Mendelsohn A, Hoffman ER, Jin R, Aucott J, Pugh SJ, Stark JH

Capabilities:
,
Validation Studies & Algorithm Development
Expertise:
,
RWE Research & Consulting