External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources-Reference-Cited by-同舟云学术

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources

Published:2023-09-01 Issue:5 Volume:208 Page:579-588
ISSN:1073-449X
Container-title:American Journal of Respiratory and Critical Care Medicine
language:en
Short-container-title:Am J Respir Crit Care Med

Author:

Swaminathan Aparna C.¹²^ORCID,Snyder Laurie D.¹²,Hong Hwanhee²³,Stevens Susanna R.²,Long Alexander S.⁴,Yanchenko Eric⁴,Qiu Ying⁵,Liu Rong⁵,Zhang Hongtao⁵,Fischer Aryeh⁵,Burns Leah⁵,Wruck Lisa M.²³,Palmer Scott M.¹²

Affiliation:

1. Department of Medicine,

2. Duke Clinical Research Institute, and

3. Department of Biostatistics and Bioinformatics, School of Medicine, Duke University, Durham, North Carolina;

4. Department of Statistics, North Carolina State University, Raleigh, North Carolina; and

5. Bristol Myers Squibb, Princeton, New Jersey

Funder

Bristol Myers Squibb

Publisher

American Thoracic Society

Subject

Critical Care and Intensive Care Medicine,Pulmonary and Respiratory Medicine

Link

https://www.atsjournals.org/doi/pdf/10.1164/rccm.202210-1947OC

Reference23 articles.

1. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis

2. A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

3. The combination of randomized and historical controls in clinical trials

4. Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe

5. Accelerating development of scientific evidence for medical products within the existing US regulatory framework

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1. The future of clinical trials in idiopathic pulmonary fibrosis;Current Opinion in Pulmonary Medicine;2024-07-04

2. A Long and Winding Road: Drug Development in Idiopathic Pulmonary Fibrosis;American Journal of Respiratory and Critical Care Medicine;2024-05-01

3. Pulmonary fibrosis: from pathogenesis to clinical decision-making;Trends in Molecular Medicine;2023-12

4. The Added Power of Synthetic Control Groups: Challenging Conventional Wisdom and Trial Design in Idiopathic Pulmonary Fibrosis Research;American Journal of Respiratory and Critical Care Medicine;2023-09-01