Clinical Trial Design Based on Time to Death/Progression.

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Paul W Noble, Carlo Albera, Williamson Z Bradford, Ulrich Costabel, Marilyn K Glassberg, David Kardatzke, Talmadge E King, Lisa Lancaster, Steven A Sahn, Javier Szwarcberg, Dominique Valeyre, Roland M du Bois, Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. The Lancet. ,vol. 377, pp. 1760- 1769 ,(2011) , 10.1016/S0140-6736(11)60405-4

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Talmadge E King, Carlo Albera, Williamson Z Bradford, Ulrich Costabel, Phil Hormel, Lisa Lancaster, Paul W Noble, Steven A Sahn, Javier Szwarcberg, Michiel Thomeer, Dominique Valeyre, Roland M du Bois, None, Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial The Lancet. ,vol. 374, pp. 222- 228 ,(2009) , 10.1016/S0140-6736(09)60551-1

Ross L. Prentice, Surrogate endpoints in clinical trials: definition and operational criteria Statistics in Medicine. ,vol. 8, pp. 431- 440 ,(1989) , 10.1002/SIM.4780080407

Talmadge E King Jr, Sharon Safrin, Karen M Starko, Kevin K Brown, Paul W Noble, Ganesh Raghu, David A Schwartz, None, Analyses of Efficacy End Points in a Controlled Trial of Interferon-γ1b for Idiopathic Pulmonary Fibrosis Chest. ,vol. 127, pp. 171- 177 ,(2005) , 10.1378/CHEST.127.1.171

Shelley L Schmidt, Nabihah Tayob, Meilan K Han, Christopher Zappala, Dolly Kervitsky, Susan Murray, Athol U Wells, Kevin K Brown, Fernando J Martinez, Kevin R Flaherty, None, Predicting Pulmonary Fibrosis Disease Course From Past Trends in Pulmonary Function Chest. ,vol. 145, pp. 579- 585 ,(2014) , 10.1378/CHEST.13-0844

Ganesh Raghu, Harold R Collard, Jim J Egan, Fernando J Martinez, Juergen Behr, Kevin K Brown, Thomas V Colby, Jean-François Cordier, Kevin R Flaherty, Joseph A Lasky, David A Lynch, Jay H Ryu, Jeffrey J Swigris, Athol U Wells, Julio Ancochea, Demosthenes Bouros, Carlos Carvalho, Ulrich Costabel, Masahito Ebina, David M Hansell, Takeshi Johkoh, Dong Soon Kim, Talmadge E King Jr, Yasuhiro Kondoh, Jeffrey Myers, Nestor L Muller, Andrew G Nicholson, Luca Richeldi, Moisés Selman, Rosalind F Dudden, Barbara S Griss, Shandra L Protzko, Holger J Schunemann, None, An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-Based Guidelines for Diagnosis and Management American Journal of Respiratory and Critical Care Medicine. ,vol. 183, pp. 788- 824 ,(2011) , 10.1164/RCCM.2009-040GL

Brett Ley, Williamson Z. Bradford, Eric Vittinghoff, Derek Weycker, Roland M. du Bois, Harold R. Collard, Predictors of Mortality Poorly Predict Common Measures of Disease Progression in Idiopathic Pulmonary Fibrosis American Journal of Respiratory and Critical Care Medicine. ,vol. 194, pp. 711- 718 ,(2016) , 10.1164/RCCM.201508-1546OC

Banu A. Karimi-Shah, Badrul A. Chowdhury, Forced Vital Capacity in Idiopathic Pulmonary Fibrosis — FDA Review of Pirfenidone and Nintedanib New England Journal of Medicine. ,vol. 372, pp. 1189- 1191 ,(2015) , 10.1056/NEJMP1500526