Publications

Publication

Considerations for Using Distributed Research Networks to Conduct Aspects of Randomized Trials

Contemporary Clinical Trials Communications

January 2, 2020

Authors:

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

Expertise:

RWE Research & Consulting

Publication

Mapping from the International Classification of Diseases (ICD) 9th to 10th Revision for Research in Biologics and Biosimilars Using Administrative Healthcare Data

Pharmacoepidemiology & Drug Safety

December 18, 2019

Authors:

He M, Santiago Ortiz AJ, Marshall J, Mendelsohn AB, Curtis JR, Barr CE, Lockhart CM, Kim SC

Expertise:

RWE Research & Consulting

Publication

Capture of Biologic and Biosimilar Dispensings in a Consortium of U.S.-Based Claims Databases - Utilization of National Drug Codes and HCPCS Modifiers in Medical Claims

Pharmacoepidemiology & Drug Safety

December 4, 2019

Authors:

Zhang J, Haynes K, Mendelsohn AB, Marshall J, Barr CE, McDermott C, Brown J, Kline A, Kenney J, King KJ, Holmes C, Yeung K, Barron J, Yun H, Lockhart CM

Expertise:

RWE Research & Consulting

Publication

Descriptive Analysis of Long- and Intermediate-Acting Insulin and Key Safety Outcomes in Adults with Type 2 Diabetes Mellitus

Journal of Managed Care & Specialty Pharmacy

November 1, 2019

Authors:

Kent DJ, McMahill-Walraven CN, Panozzo CA, Pawloski PA, Haynes K, Marshall J, Brown J, Eichelberger B, Lockhart CM

Capabilities:

Multi-Site Methods & Coordination

Expertise:

RWE Research & Consulting

Publication

Harnessing the Biologics and Biosimilars Collective Intelligence Consortium to Evaluate Patterns of Care

Journal of Managed Care & Specialty Pharmacy

November 1, 2019

Authors:

McMahill-Walraven CN, Kent DJ, Panozzo CA, Pawloski PA, Haynes K, Marshall J, Brown J, Eichelberger B, Lockhart CM

Expertise:

RWE Research & Consulting

Protocol

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

October 17, 2019

Authors:

Harvard Pilgrim Health Care Institute, Reagan-Udall Foundation for FDA, CVS Health, Carelon Research, Humana HealthCare Research, Health Partners Institute, Marshfield Clinic Health System, Vanderbilt University Medical Center, Meyers Primary Care Institute, Optum Epidemiology, Merck Sharp & Dohme LLC

Capabilities:

Multi-Site Methods & Coordination

Expertise:

Regulatory Research & Support

RWE Research & Consulting

Publication

Antibiotic Dispensing Following Pediatric Visits in the US Emergency Departments and Outpatient Settings from 2006 to 2016

Pharmacology Research & Perspectives

October 7, 2019

Authors:

Agiro A, Sridhar G, Gordon A, Brown J, Haynes K

Capabilities:

Multi-Site Methods & Coordination

Expertise:

RWE Research & Consulting

Publication

Barriers and Facilitators to Conduct High-Quality, Large-Scale Safety and Comparative Effectiveness Research: The Biologics and Biosimilars Collective Intelligence Consortium Experience

Pharmacoepidemiology & Drug Safety

August 11, 2019

Authors:

Lockhart CM, McDermott CL, Felix T, Lin ND, Cziraky MJ, Mendelsohn AB, Brown JS

Expertise:

RWE Research & Consulting

Conference Abstract

ICD-9 to ICD-10 Mapping for Research in Biologics and Biosimilars Using Administrative Healthcare Data

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conference 2019

May 1, 2019

Authors:

He M, Ortiz AJ, Marshall J, Mendelsohn AB, Curtis JR, Barr CE, Lockhart C, Kim SC

Expertise:

RWE Research & Consulting

Conference Abstract

Perspectives from a Coordinating Center: Lessons Learned from the Biologics and Biosimilars Collective Intelligence Consortium

Health Care Systems Research Network Conference 2019

April 8, 2019

Authors:

Malek S, King KJ, Lockhart CM, Mendelsohn AB, Brown J

Expertise:

RWE Research & Consulting

Conference Abstract

Evaluating Biologics and Their Biosimilars Using a Distributed Research Network to Demonstrate Real-World Outcomes

Academy of Managed Care Pharmacy Nexus 2018

October 26, 2018

Authors:

Pawloski PA, Haynes K, Kent D, McMahill-Walraven CN, Panozzo CA, Pindolia V, Lockhart CM, Brown J, Mendelsohn A, Barr CE, Eichelberger B

Expertise:

RWE Research & Consulting

Conference Abstract

Differentiation of Adults with Type 1 Versus Type 2 Diabetes in Administrative Claims Analysis: Experience from the Biologics and Biosimilars Collective Intelligence Consortium

Academy of Managed Care Pharmacy Nexus 2018

October 25, 2018

Authors:

McMahill-Walraven C, Kent D, Marshall J, Lockhart CM, and the BBCIC Insulin Research Team

Expertise:

RWE Research & Consulting

Conference Abstract

Development and Management of a Distributed Research Network for Evaluating Real-World Outcomes for Biologics and Their Biosimilars

Academy of Managed Care Pharmacy Nexus 2018

October 25, 2018

Authors:

Mendelsohn AB, Barr CE, Brown J, Cziraky M, King K, Lin N, Lockhart CM, Pawloski PA, Eichelberger B

Expertise:

RWE Research & Consulting

Publication

Do FDA Label Changes Work? Assessment of the 2010 Class Label Change for Proton Pump Inhibitors Using the Sentinel System's Analytic Tools

Pharmacoepidemiology & Drug Safety

February 2, 2018

Authors:

Sobel RE, Bate A, Marshall J, Haynes K, Selvam N, Nair V, Daniel G, Brown JS, Reynolds RF

Expertise:

RWE Research & Consulting

Conference Abstract

Safety of Trumenba Vaccine Among Pregnant Women in the United States: Planning and Design of a Large-Scale Multi-Site Observational Study

33th Annual International Society for Pharmacoepidemiology Conference

August 22, 2017

Authors:

Panozzo CA, Purcell B, Andrade S, Griffin MR, Haynes K, Lin ND, McMahill-Walraven CN, Naleway A, Young J, Brown JS, Stark J

Capabilities:

Pregnancy & Mother-Infant Linked Studies

Multi-Site Methods & Coordination

Expertise:

Regulatory Research & Support

RWE Research & Consulting

Conference Abstract

Oral Contraceptives and VTE Across the Sentinel Data Network-An IMEDS Evaluation Pilot Assessment

32th Annual International Society for Pharmacoepidemiology Conference

August 24, 2016

Authors:

Bate A, Sobel R, Marshall J, Daniel G, McCall T, Reynolds R, Brown J

Expertise:

RWE Research & Consulting

Publication

A Comparative Assessment of Observational Medical Outcomes Partnership and Mini-Sentinel Common Data Models and Analytics: Implications for Active Drug Safety Surveillance

Drug Safety

June 9, 2015

Authors:

Xu Y, Zhou X, Suehs BT, Hartzema AG, Kahn MG, Moride Y, Sauer BC, Liu Q, Moll K, Pasquale MK, Nair VP, Bate A

Expertise:

RWE Research & Consulting

Publication

Utilizing Data Consortia to Monitor Safety and Effectiveness of Biosimilars and Their Innovator Products

Journal of Managed Care & Specialty Pharmacy

January 21, 2015

Authors:

AMCP Task Force on Biosimilar Collective Intelligence Systems; Baldziki M, Brown J, Chan H, Cheetham TC, Conn T, Daniel GW, Hendrickson M, Hilbrich L, Johnson A, Miller SB, Moore T, Motheral B, Priddy SA, Raebel MA, Randhawa G, Surratt P, Walraven C, White TJ, Bruns K, Carden MJ, Dragovich C, Eichelberger B, Rosato E, Sega T

Expertise:

RWE Research & Consulting

Publication

Four Health Data Networks Illustrate the Potential for a Shared National Multipurpose Big-Data Network

Health Affairs

July 1, 2014

Authors:

Curtis LH, Brown J, Platt R

Expertise:

RWE Research & Consulting