Idiopathic pulmonary fibrosis trials: recommendations for the jury

Idiopathic pulmonary fibrosis (IPF) is a disease with a dismal prognosis and a median survival of only 2–3 yrs. There are no licensed medical therapies in the USA and the only care options that are endorsed by the most recent consensus guidelines are lung transplantation and enrolment in a clinical trial [1]. Although the past decade has seen numerous trials in IPF being undertaken and completed, the outcomes have mostly been disappointing with only one or two exceptions [2, 3]. Despite this, valuable insights about the natural history and course of the disease have been gained from the well-characterised patient data sets of these trials. However, these studies have raised many questions and fuelled the continuing debate on how future IPF trials should be designed. There are many considerations and challenges involved in the implementation and completion of IPF studies. The complex nature of the pathogenic process, the highly variable disease course, the possibility of inadequate drug deposition in the targeted area and the uncertainty about the most appropriate end-points may all confound the interpretation of clinical trial results.