title: A new era in idiopathic pulmonary fibrosis: considerations for future clinical trials.
abstract: The past decade has seen substantial progress in understanding the pathobiology, natural history, and clinical significance of idiopathic pulmonary fibrosis (IPF), culminating in the establishment of two effective medical therapies. Now seems an important time to reconsider the design and conduct of future IPF clinical trials. Building on lessons learned over the past decade, we use this perspective to lay out four key considerations for moving forward effectively and efficiently with the next generation of clinical trials in IPF. These are: development of a coordinated IPF clinical trials network; establishment of expectations for early phase proof of concept studies; adaptation of late-phase efficacy trial designs to the emergence of approved therapies, and; agreement on primary end-points for late phase clinical trials. Continued progress in the field of IPF will require creativity and collaboration on the part of all stakeholders. We believe that addressing these four considerations will encourage and enable investment in this new era of drug development in IPF, and will lead to more rapid development of effective therapies.
authors.affiliation: Dept of Medicine, University of California San Francisco, San Francisco, CA, USA hal.collard@ucsf.edu.
authors.forename: Harold R
authors.initials: HR
authors.lastname: Collard
authors.affiliation: InterMune, Brisbane, CA, USA.
authors.forename: Williamson Z
authors.initials: WZ
authors.lastname: Bradford
authors.affiliation: National Reference Center for Rare Pulmonary Diseases, Hôpitaux de Lyon, University Claude Bernard Lyon 1, Lyon, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Cottin
authors.affiliation: Dept of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Flaherty
authors.affiliation: Dept of Medicine, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Talmadge E
authors.initials: TE
authors.lastname: King
authors.affiliation: Dept of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Gary G
authors.initials: GG
authors.lastname: Koch
authors.affiliation: Dept of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Martin
authors.initials: M
authors.lastname: Kolb
authors.affiliation: Dept of Medicine, Weill Cornell Medical College, New York, NY, USA.
authors.forename: Fernando J
authors.initials: FJ
authors.lastname: Martinez
authors.affiliation: Cardeas Pharma, Seattle, WA, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Montgomery
authors.affiliation: Dept of Medicine, University of Washington, Seattle, WA, USA.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Raghu
authors.affiliation: NIHR Southampton Respiratory Biomedical Research Unit, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
authors.forename: Luca
authors.initials: L
authors.lastname: Richeldi
authors.affiliation: Pulmonary Fibrosis Foundation, Chicago, IL, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Rose
authors.affiliation: Interstitial Lung Disease Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK.
authors.forename: Athol U
authors.initials: AU
authors.lastname: Wells
authors.affiliation: Dept of Medicine, National Jewish Health, Denver, CO, USA.
authors.forename: Kevin K
authors.initials: KK
authors.lastname: Brown
mesh_terms: D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic; D018450:Disease Progression; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy / Q000628:therapy*; D015272:Pulmonary Medicine / Q000639:trends; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers