@article{locke_uncomfortable_2023,
	title = {Uncomfortable {Truths} {About} {Data}, {Justice}, and {Idiopathic} {Pulmonary} {Fibrosis} in the {Veterans} {Health} {Administration}},
	volume = {164},
	issn = {0012-3692},
	url = {https://journal.chestnet.org/article/S0012-3692(23)00465-8/abstract},
	doi = {10.1016/j.chest.2023.03.037},
	abstract = {The 2014 approvals of pirfenidone and nintedanib for use in idiopathic pulmonary fibrosis
(IPF) by the US Food and Drug Administration were notable in the acceptance of an
unproven surrogate end point: decrease in the rate of FVC decline. They offered the
following rationale1: (1) IPF carries a dire prognosis, with a current mean survival
of 4 years2 and no disease-modifying treatments; (2) the preferred clinical efficacy
end point (death) would require a prohibitively large, slow, and expensive trial;
and (3) both the natural disease course and cumulative trial data suggest that reduced
spirometric decline ultimately would translate to improvements in mortality rates
and other patient-important end points.},
	language = {English},
	number = {2},
	urldate = {2024-12-13},
	journal = {CHEST},
	author = {Locke, Brian W. and Callahan, Sean J.},
	month = aug,
	year = {2023},
	pmid = {37558321},
	note = {Publisher: Elsevier},
	pages = {280--282},
}

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