Publications

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

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Conference Abstract

Background rates of neuroinflammatory disorders and atrial fibrillation - conditions of interest for vaccine safety studies

August 24, 2024
Authors:

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

Capabilities:
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Multi-Site Methods & Coordination
Expertises:
,
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:
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Pregnancy & Mother-Infant Linked Studies
,
Multi-Site Methods & Coordination
Expertises:
,
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

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

Risk of incident gout following exposure to recombinant zoster vaccine in US adults aged ≥50 years

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:
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Multi-Site Methods & Coordination
Expertises:
,
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

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:
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Multi-Site Methods & Coordination
Expertises:
,
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.

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

Expertises:
,
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:
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Pregnancy & Mother-Infant Linked Studies
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Validation Studies & Algorithm Development
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Multi-Site Methods & Coordination
Expertises:
,
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:
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Pregnancy & Mother-Infant Linked Studies
,
Multi-Site Methods & Coordination
Expertises:
,
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

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

Extending an under-recognized burden of Lyme Disease with administrative claims data

October 22, 2023
Authors:

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

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

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

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
Expertises:
,
RWE Research & Consulting
Conference Abstract

Monitoring Results From a Postapproval Safety Study of Pfizer-BioNTech COVID-19 Vaccine in the United States: Vaccine Utilization and Incidence Rates of Myocarditis/Pericarditis

August 1, 2023
Authors:

Kawai A, Fuller CC, Koram N, Agan A, Brown J, Burk J, Cai B, Daniels K, Fearrington J, Franklin JM, Hague C, Jamal-Allial A, Johannes CB, Kempner M, Layton JB, Ma Q, Mai XM, Mayer S, Pawloski PA, Reynolds J, Seals R, Selvan M, Smith S, McMahill-Walraven CN, Gilsenan A, Platt R

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

Use of Janssen Ad26.COV2.S COVID-19 Vaccine (JCOVDEN) and mRNA COVID-19 Vaccines in Four Large US National Insurers

August 1, 2023
Authors:

Mayer SE, Fuller CC, Haynes K, Alam S, Brown JS, Daniels K, Hawrusik R, Horgan C, Jamal-Allial A, Johannes CB, Kawai AT, Layton JB, Mai XM, Marshall J, McMahill-Walraven CN, Reynolds JS, Seals R, Selvan M, Stemkowski S, Wang FT, Yost E, Gilsenan A, Platt R

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

Postmarketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age

March 31, 2023
Authors:

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, Optum Epidemiology, GlaxoSmithKline

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

Identification of cancer chemotherapy regimens and patient cohorts in administrative claims: challenges, opportunities, and a proposed algorithm

March 14, 2023
Authors:

Lockhart CM, McDermott CL, Mendelsohn AB, Marshall J, McBride A, Yee G, Sam Li M, Jamal-Allial A, Djibo DA, Benitez GV, DeFor TA, Pawloski PA

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

Using the IMEDS Distributed Database for Epidemiological Studies in Type 2 Diabetes Mellitus.

December 19, 2022
Authors:

Huang TY, Rodriguez-Watson C, Wang T, Calhoun SR, Marshall J, Burk J, Nam YH, Mendelsohn AB, Adgent M,  Jamal-Allial A, Greenlee RT, Nair V, Pawloski PA, McMahill Walraven CN, Toh S, Brown JS

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

An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States

November 21, 2022
Authors:

Harvard Pilgrim Health Care Institute, RTI Health Solutions, CVS Health, Carelon Research, Humana HealthCare Research, Optum Epidemiology, Johnson & Johnson

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

Healthcare claims-based Lyme disease case-finding algorithms in the United States: a systematic literature review

October 27, 2022
Authors:

Nam YH, Willis S, Mendelsohn AB, Forrow S, Gessner BD, Stark JH, Brown JS, Pugh S

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

Patient characteristics, pain treatment patterns, and incidence of total joint replacement in a US population with osteoarthritis.

September 23, 2022
Authors:

Shinde M, Rodriguez-Watson C, Zhang TC, Carrell DS, Mendelsohn AB, Nam YH, Carruth A, Petronis KR, McMahill-Walraven CN, Jamal-Allial A, Nair V, Pawloski PA, Hickman A, Brown MT, Francis J, Hornbuckle K, Brown JS, Mo J

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