Primary endpoints in phase 3 clinical trials in idiopatic pulmonary fibrosis: one step at a time

The recent Perspective article by Raghu and colleagues has triggered debate on how best to judge efficacy in Phase III clinical trials for idiopathic pulmonary fibrosis (IPF). Raghu et al nominate all-cause mortality and all-cause hospitalization as their chosen ideal end-points. Their paper does not make explicit recommendations regarding new drug approvals, but, given the standing of the authors, the impact of their conclusions on licensing authorities cannot be ignored. The recommendations put forward by Raghu and co-authors have caused considerable concern amongst researchers in the field and a strongly worded counterpoint has already been published. We feel however, that such is the importance of this issue, further comment is warranted.