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Real‐world evidence to advance knowledge in pulmonary hypertension: Status, challenges, and opportunities. A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative's Real‐world Evidence Working Group

by Hobohm, Lukas , Benza, Raymond L. , Williams, Paul G. , Harikrishnan, Sivadasanpillai , Mercurio, Valentina , Nikkho, Sylvia M. , Minty, Evan P. , Jose, Arun , Badagliacca, Roberto , Lau, Edmund M. T. , Elliott, C. Gregory , Gerges, Christian , Mathai, Stephen C. , Qian, Junyan , Jing, Zhi‐Cheng , Visovatti, Scott H. , Boucly, Athénaïs , Fauvel, Charles , Strange, Geoff , Vanderpool, Rebecca R. , Cirulis, Meghan M. , Li, Mengtao , Weatherald, Jason , Sahay, Sandeep , Zelt, Jason G. E. , Gillmeyer, Kari R. , Leonidas Alves, Jose , Morland, Kellie , Moles, Victor M. , Elwing, Jean , Pulido, Tomas

in administrative claims data / Biometrics / Clinical trials / Drug development / Electronic health records / FDA approval / Health care delivery / Missing data / Patients / patient‐generated health data / Pulmonary hypertension / real‐world data / registries / Regulatory approval / Reimbursement / Social networks / Wearable computers

2023

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Journal Article

Real‐world evidence to advance knowledge in pulmonary hypertension: Status, challenges, and opportunities. A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative's Real‐world Evidence Working Group

Hobohm, Lukas,

Benza, Raymond L.,

Williams, Paul G.,

Harikrishnan, Sivadasanpillai,

Mercurio, Valentina,

Nikkho, Sylvia M.,

Minty, Evan P.,

Jose, Arun,

Badagliacca, Roberto,

Lau, Edmund M. T.,

Elliott, C. Gregory,

Gerges, Christian,

Mathai, Stephen C.,

Qian, Junyan,

Jing, Zhi‐Cheng,

Visovatti, Scott H.,

Boucly, Athénaïs,

Fauvel, Charles,

Strange, Geoff,

Vanderpool, Rebecca R.,

Cirulis, Meghan M.,

Li, Mengtao,

Weatherald, Jason,

Sahay, Sandeep,

Zelt, Jason G. E.,

Gillmeyer, Kari R.,

Leonidas Alves, Jose,

Morland, Kellie,

Moles, Victor M.,

Elwing, Jean,

Pulido, Tomas

2023

Overview

This manuscript on real‐world evidence (RWE) in pulmonary hypertension (PH) incorporates the broad experience of members of the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative Real‐World Evidence Working Group. We aim to strengthen the research community's understanding of RWE in PH to facilitate clinical research advances and ultimately improve patient care. Herein, we review real‐world data (RWD) sources, discuss challenges and opportunities when using RWD sources to study PH populations, and identify resources needed to support the generation of meaningful RWE for the global PH community.

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Publisher

John Wiley & Sons, Inc,Wiley

Subject

administrative claims data

/ Biometrics

/ Clinical trials

/ Drug development

/ Electronic health records

/ FDA approval

/ Health care delivery