Ganesh Raghu, Marya Ghazipura, Thomas R Fleming, Kerri I Aronson, Jürgen Behr, Kevin K Brown, Kevin R Flaherty, Ella A Kazerooni, Toby M Maher, Luca Richeldi, Joseph A Lasky, Jeffrey J Swigris, Robert Busch, Lili Garrard, Dong-Hyun Ahn, Ji Li, Khalid Puthawala, Gabriela Rodal, Sally Seymour, Nargues Weir, Sonye K Danoff, Neil Ettinger, Jonathan Goldin, Marilyn K Glassberg, Leticia Kawano-Dourado, Nasreen Khalil, Lisa Lancaster, David A Lynch, Yolanda Mageto, Imre Noth, Jessica E Shore, Marlies Wijsenbeek, Robert Brown, Daniel Grogan, Dorothy Ivey, Patrycja Golinska, Banu A Karimi-Shah, Fernando J Martinez
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...
January 4, 2024: American Journal of Respiratory and Critical Care Medicine