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

Author:

Morland Kellie1ORCID,Gerges Christian2,Elwing Jean3,Visovatti Scott H.4,Weatherald Jason5,Gillmeyer Kari R.67ORCID,Sahay Sandeep8ORCID,Mathai Stephen C.9,Boucly Athénaïs101112,Williams Paul G.13,Harikrishnan Sivadasanpillai14,Minty Evan P.15,Hobohm Lukas1617ORCID,Jose Arun3,Badagliacca Roberto18,Lau Edmund M. T.1920,Jing Zhi‐Cheng21ORCID,Vanderpool Rebecca R.4,Fauvel Charles22,Leonidas Alves Jose23,Strange Geoff24,Pulido Tomas25,Qian Junyan26,Li Mengtao26,Mercurio Valentina27,Zelt Jason G. E.28,Moles Victor M.29,Cirulis Meghan M.3031,Nikkho Sylvia M.32ORCID,Benza Raymond L.33ORCID,Elliott C. Gregory3031

Affiliation:

1. Global Medical Affairs United Therapeutics Corporation Research Triangle Park North Carolina USA

2. Department of Internal Medicine II, Division of Cardiology Medical University of Vienna Vienna Austria

3. Division of Pulmonary, Critical Care, and Sleep Medicine University of Cincinnati Cincinnati Ohio USA

4. Division of Cardiovascular Medicine The Ohio State University Columbus Ohio USA

5. Department of Medicine, Division of Pulmonary Medicine University of Alberta Edmonton Canada

6. The Pulmonary Center Boston University Chobian & Avedisian School of Medicine Boston Massachusetts USA

7. Center for Healthcare Organization & Implementation Research VA Bedford Healthcare System and VA Boston Healthcare System Bedford Massachusetts USA

8. Division of Pulmonary, Critical Care & Sleep Medicine Houston Methodist Hospital Houston Texas USA

9. Division of Pulmonary and Critical Care Medicine Johns Hopkins University School of Medicine Baltimore Maryland USA

10. Faculté de Médecine Université Paris‐Saclay Le Kremlin‐Bicêtre France

11. Service de Pneumologie et Soins Intensifs Respiratoires, Centre de Référence de l'Hypertension Pulmonaire, Hôpital Bicêtre Assistance Publique Hôpitaux de Paris Le Kremlin Bicêtre France

12. National Heart and Lung Institute Imperial College London UK

13. Center of Chest Diseases & Critical Care Milpark Hospital Johannesburg South Africa

14. Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum Kerala India

15. Department of Medicine & O'Brien Institute for Public Health University of Calgary Calgary Canada

16. Department of Cardiology University Medical Center of the Johannes Gutenberg University Mainz Mainz Germany

17. Center for Thrombosis and Hemostasis (CTH) University Medical Center of the Johannes Gutenberg University Mainz Mainz Germany

18. Department of Clinical, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome Policlinico Umberto I Rome Italy

19. Department of Respiratory Medicine, Royal Prince Alfred Hospital University of Sydney Camperdown New South Wales Australia

20. Faculty of Medicine and Health University of Sydney Camperdown New South Wales Australia

21. State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China

22. Service de Cardiologie, Centre de Compétence en Hypertension Pulmonaire 27/76, Centre Hospitalier Universitaire Charles Nicolle, INSERM EnVI U1096 Université de Rouen Rouen France

23. Pulmonary Division, Heart Institute University of São Paulo Medical School São Paulo Brazil

24. School of Medicine The University of Notre Dame Australia Perth Western Australia Australia

25. Ignacio Chávez National Heart Institute México City Mexico

26. Department of Rheumatology and Clinical Immunology, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC‐DID), Ministry of Science & Technology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital (PUMCH), Key Laboratory of Rheumatology and Clinical Immunology Ministry of Education Beijing China

27. Department of Translational Medical Sciences Federico II University Naples Italy

28. Department of Medicine, Faculty of Medicine University of Ottawa Ottawa Canada

29. Division of Cardiovascular Medicine University of Michigan Ann Arbor Michigan USA

30. Division of Pulmonary and Critical Care Medicine University of Utah Salt Lake City Utah USA

31. Department of Pulmonary and Critical Care Medicine Intermountain Medical Center Murray Salt Lake City Utah USA

32. Global Clinical Development Bayer AG Berlin Germany

33. Mount Sinai Heart Icahn School of Medicine at Mount Sinai New York New York USA

Abstract

AbstractThis 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.

Publisher

Wiley

Subject

Pulmonary and Respiratory Medicine

Reference173 articles.

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