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1. Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on ‘Feels, Functions, Survives’. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency

Author

Raghu, Ganesh, primary, Ghazipura, Marya, additional, Fleming, Thomas R., additional, Aronson, Kerri I., additional, Behr, Jürgen, additional, Brown, Kevin K., additional, Flaherty, Kevin R., additional, Kazerooni, Ella A., additional, Maher, Toby M., additional, Richeldi, Luca, additional, Lasky, Joseph A., additional, Swigris, Jeffrey J., additional, Busch, Robert, additional, Garrard, Lili, additional, Ahn, Dong-Hyun, additional, Li, Ji, additional, Puthawala, Khalid, additional, Rodal, Gabriela, additional, Seymour, Sally, additional, Weir, Nargues, additional, Danoff, Sonye K., additional, Ettinger, Neil, additional, Goldin, Jonathan, additional, Glassberg, Marilyn K., additional, Kawano-Dourado, Leticia, additional, Khalil, Nasreen, additional, Lancaster, Lisa, additional, Lynch, David A., additional, Mageto, Yolanda, additional, Noth, Imre, additional, Shore, Jessica E., additional, Wijsenbeek, Marlies, additional, Brown, Robert, additional, Grogan, Daniel, additional, Ivey, Dorothy, additional, Golinska, Patrycja, additional, Karimi-Shah, Banu, additional, and Martinez, Fernando J., additional

Published
2024
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2. Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on 'Feels, Functions, Survives'

Author

Raghu, Ganesh, Ghazipura, Marya, Fleming, Thomas R., Aronson, Kerri I, Behr, Jürgen, Brown, Kevin K, Flaherty, Kevin R., Kazerooni, Ella A, Maher, Toby M, Richeldi, Luca, Lasky, Joseph A., Swigris, Jeffrey J, Busch, Robert, Garrard, Lili, Ahn, Dong-Hyun, Li, Ji, Puthawala, Khalid, Rodal, Gabriela, Seymour, Sally, Weir, Nargue, Danoff, Sonye K., Ettinger, Neil, Goldin, Jonathan, Glassberg, Marilyn K, Kawano-Dourado, Leticia, Khalil, Nasreen, Lancaster, Lisa, Lynch, David A., Mageto, Yolanda, Noth, Imre, Shore, Jessica E, Wijsenbeek, Marlie, Brown, Robert, Grogan, Daniel, Ivey, Dorothy, Golinska, Patrycja, Karimi-Shah, Banu A., Martinez, Fernando J., Richeldi, Luca (ORCID:0000-0001-8594-1448), Raghu, Ganesh, Ghazipura, Marya, Fleming, Thomas R., Aronson, Kerri I, Behr, Jürgen, Brown, Kevin K, Flaherty, Kevin R., Kazerooni, Ella A, Maher, Toby M, Richeldi, Luca, Lasky, Joseph A., Swigris, Jeffrey J, Busch, Robert, Garrard, Lili, Ahn, Dong-Hyun, Li, Ji, Puthawala, Khalid, Rodal, Gabriela, Seymour, Sally, Weir, Nargue, Danoff, Sonye K., Ettinger, Neil, Goldin, Jonathan, Glassberg, Marilyn K, Kawano-Dourado, Leticia, Khalil, Nasreen, Lancaster, Lisa, Lynch, David A., Mageto, Yolanda, Noth, Imre, Shore, Jessica E, Wijsenbeek, Marlie, Brown, Robert, Grogan, Daniel, Ivey, Dorothy, Golinska, Patrycja, Karimi-Shah, Banu A., Martinez, Fernando J., and Richeldi, Luca (ORCID:0000-0001-8594-1448)

Abstract

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's "feels, functions, survives" criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures . Conclusion: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.

Published
2024

3. Pulmonary Fibrosis Stakeholder Summit: A Joint National Heart, Lung, and Blood Institute, Three Lakes Foundation, and Pulmonary Fibrosis Foundation Workshop Report

Author

Montesi, Sydney B, primary, Gomez, Christian R, additional, Beers, Michael, additional, Brown, Robert, additional, Chattopadhyay, Ishanu, additional, Flaherty, Kevin R., additional, Garcia, Christine Kim, additional, Gomperts, Brigitte, additional, Hariri, Lida P, additional, Hogaboam, Cory M, additional, Jenkins, R. Gisli, additional, Kaminski, Naftali, additional, Kim, Grace Hyun J., additional, Königshoff, Melanie, additional, Kolb, Martin, additional, Kotton, Darrell N, additional, Kropski, Jonathan A., additional, Lasky, Joseph, additional, Magin, Chelsea M., additional, Maher, Toby M., additional, McCormick, Mark, additional, Moore, Bethany B, additional, Nickerson-Nutter, Cheryl, additional, Oldham, Justin, additional, Podolanczuk, Anna J., additional, Raghu, Ganesh, additional, Rosas, Ivan, additional, Rowe, Steven M, additional, Schmidt, William T., additional, Schwartz, David, additional, Shore, Jessica E, additional, Spino, Cathie, additional, Craig, Matthew, additional, and Martinez, Fernando J., additional

Published
2023
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5. Differences in Patient Outcomes across the Pulmonary Fibrosis Foundation Care Center Network

Author

Boente, Ryan D., primary, White, Emily N., additional, Baxter, Caitlin M., additional, Shore, Jessica E., additional, Collard, Harold R., additional, Lee, Joyce S., additional, Abrencillo, Rodeo, additional, Bhatt, Nitin, additional, Boente, Ryan, additional, Farrand, Erica, additional, Glazer, Craig, additional, Huie, Tristan, additional, Kim, Hyun, additional, Ramaswamy, Murali, additional, Shah, Rupal, additional, Shore, Jessica, additional, and Thavarajah, Krishna, additional

Published
2023
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6. Pulmonary Fibrosis Stakeholder Summit: A Joint NHLBI, Three Lakes Foundation, and Pulmonary Fibrosis Foundation Workshop Report.

Author

Montesi SB, Gomez CR, Beers M, Brown R, Chattopadhyay I, Flaherty KR, Garcia CK, Gomperts B, Hariri LP, Hogaboam CM, Jenkins RG, Kaminski N, Kim GHJ, Königshoff M, Kolb M, Kotton DN, Kropski JA, Lasky J, Magin CM, Maher TM, McCormick M, Moore BB, Nickerson-Nutter C, Oldham J, Podolanczuk AJ, Raghu G, Rosas I, Rowe SM, Schmidt WT, Schwartz D, Shore JE, Spino C, Craig JM, and Martinez FJ

Subjects
United States, Humans, National Heart, Lung, and Blood Institute (U.S.), Lakes, Risk Factors, Idiopathic Pulmonary Fibrosis diagnosis, Idiopathic Pulmonary Fibrosis therapy, Biomedical Research
Abstract

Despite progress in elucidation of disease mechanisms, identification of risk factors, biomarker discovery, and the approval of two medications to slow lung function decline in idiopathic pulmonary fibrosis and one medication to slow lung function decline in progressive pulmonary fibrosis, pulmonary fibrosis remains a disease with a high morbidity and mortality. In recognition of the need to catalyze ongoing advances and collaboration in the field of pulmonary fibrosis, the NHLBI, the Three Lakes Foundation, and the Pulmonary Fibrosis Foundation hosted the Pulmonary Fibrosis Stakeholder Summit on November 8-9, 2022. This workshop was held virtually and was organized into three topic areas: 1 ) novel models and research tools to better study pulmonary fibrosis and uncover new therapies, 2 ) early disease risk factors and methods to improve diagnosis, and 3 ) innovative approaches toward clinical trial design for pulmonary fibrosis. In this workshop report, we summarize the content of the presentations and discussions, enumerating research opportunities for advancing our understanding of the pathogenesis, treatment, and outcomes of pulmonary fibrosis.

Published
2024
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