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

The US Food and Drug Administration Sentinel System: a national resource for a learning health system

September 12, 2022
Authors:

Brown JS, Mendelsohn AB, Nam YH, Maro JC, Cocoros NM, Rodriguez-Watson C, Lockhart CM, Platt R, Ball R, Dal Pan GJ, Toh S

Expertises:
,
RWE Research & Consulting
Conference Abstract

Utilization, user characteristics, and adverse outcomes of insulin glargine originators and follow-on drug in patients with diabetes in the US

August 1, 2022
Authors:

Rai A, Nam YH, Mendelsohn AB, Marshall J, McDermott CL, Toh S, Lockhart CM

Expertises:
,
RWE Research & Consulting
Conference Abstract

Adapting to the Dynamic Landscape of the COVID-19 Pandemic: Proposed Study Design Approaches for a Postauthorization Safety Study for Pfizer-BioNTech COVID-19 Vaccine in the United States

August 1, 2022
Authors:

Kawai A, Fuller CC, deLuise C, Layton JB, Johannes CB, Brown JS, Platt R, Gilsenan

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

Capacity for identifying Janssen Ad26.COV2.S COVID 19 vaccination in four US health insurance and state Immunization Information System databases: Preparation for a post authorization safety study

August 1, 2022
Authors:

Fuller CC, Kawai AT, Haynes K, Coughlin K, Hawrusik R, Horgan C, Reynolds JS, Calingaert B, Johannes CB, Layton JB, Peterson A, Praet N, Willame C, Yost E, Brannan C, McMahill-Walraven CN, Guzman M, Jamal-Allial A, Nair V, Ma Q, Selvan M, Seals R, Wang FT, Platt R, Gilsenan A, Brown JS

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

Challenges to Identification of Cancer Chemotherapy Regimens and Patient Cohorts in Administrative Claims

July 1, 2022
Authors:

Lockhart CM, McDermott CL, Vazquez Benitez G, DeFor T, Mendelsohn A, Marshall J, McBride A, Moyneur E, Pawloski PA; on behalf of the G-CSF Comparative Effectiveness Research Team.

Expertises:
,
RWE Research & Consulting
Conference Abstract

Validating a claims-based algorithm for Lyme Disease in Massachusetts

June 1, 2022
Authors:

Kluberg SA, Willis SJ, Cocoros NM, Forrow SR, Gessner BD, Hoffman ER, Jin R, Mendelsohn A, Nam YH, Nutt C, Petrou N, Rhee C, Sury M, Aucott J, Stark J, Pugh SJ

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

Characteristics of new adult users of mepolizumab with asthma in the USA

November 8, 2021
Authors:

Wu AC, McMahon PM, Welch E, McMahill-Walraven CN, Jamal-Allial A, Gallagher M, Zhang T, Draper C, Kline AM, Koerner L, Brown JS, Van Dyke MK

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

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

October 19, 2021
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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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
Publication

BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated with High Neutropenia Risk Chemotherapy

August 16, 2021
Authors:

Pawloski PA, McDermott CL, Marshall JH, Pindolia V, Lockhart CM, Panozzo CA, Brown JS, Eichelberger B

Expertises:
,
RWE Research & Consulting
Conference Abstract

Cohort study assessing angioedema risk in Black heart failure patients using angiotensin-converting enzyme inhibitors in the United States interim results

August 1, 2021
Authors:

Connolly JG, Mendelsohn AB, Rodriguez-Watson C, McMahill-Walraven CN, Selvan M, Adgent MA, Pawloski PA, Behr S, Brown JS, Schlienger RG

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

A New United States Database for Pharmacoepidemiology Studies in Type 2 Diabetes Mellitus: the IMEDS Distributed Database

August 1, 2021
Authors:

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

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

Health outcomes coding trends in the US Food and Drug Administration's Sentinel System during transition to International Classification of Diseases-10 coding system: A brief review

March 17, 2021
Authors:

Nam YH, Mendelsohn AB, Panozzo CA, Maro JC, Brown JS

Expertises:
,
RWE Research & Consulting
Protocol

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

March 16, 2021
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
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Multi-Site Methods & Coordination
Expertises:
,
Regulatory Research & Support
,
RWE Research & Consulting
Publication

Utilization patterns and characteristics of users of biologic anti-inflammatory agents in a large, US commercially insured population

February 1, 2021
Authors:

Mendelsohn AB, Nam YH, Marshall J, McDermott CL, Kochar B, Kappelman MD, Brown JS, Lockhart CM

Expertises:
,
RWE Research & Consulting
Publication

Patient Characteristics and Utilization Patterns of Short-Acting Recombinant Granulocyte Colony-Stimulating Factor (G-CSF) Biosimilars Compared to Their Reference Product

January 30, 2021
Authors:

Mendelsohn AB, Marshall J, McDermott CL, Pawloski PA, Brown JS, Lockhart CM

Expertises:
,
RWE Research & Consulting
Conference Abstract

Selecting an appropriate comparator group in vaccine cohort studies of older adults: recombinant zoster vaccine (RZV) as an example

September 16, 2020
Authors:

Han J, Talarico C, Back S, dosReis S, Jamal-Allial A, McMahill-Walraven C, Menzin T,  Nair V,  Nam YH, Ocran-Appiah J, Brown J, Yih WK

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

A targeted safety study, EPI-ZOSTER-030 VS US DB, to evaluate the safety of Shingrix in adults ≥ 50 years of age in the United States

September 11, 2020
Authors:

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

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

Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance

April 1, 2020
Authors:

Zhang J, Sridhar G, Barr CE, Eichelberger B, Lockhart CM, Marshall J, Clewell J, Accortt NA, Curtis JR, Holmes C, McMahill-Walraven CN, Brown JS, Haynes K.

Expertises:
,
RWE Research & Consulting
Conference Abstract

Use of Mepolizumab Among Individuals with Asthma in the U.S.

February 1, 2020
Authors:

Wu AC, McMahon P, Mendelsohn A, Welch E, Gokhale M, McMahill-Walraven C, Zhang J, Jamal-Allial A, Gallagher M, Draper C, Kline A, Koerner L, Brown J, VanDyke M

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

Considerations for using distributed research networks to conduct aspects of randomized trials

January 2, 2020
Authors:

Marsolo KA, Brown JS, Hernandez AF, Hammill BG, Raman SR, Syat B, Platt R, Curtis LH

Expertises:
,
RWE Research & Consulting