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- Title
Clinical trials and tribulations—lessons from pulmonary fibrosis.
- Authors
Olson, A.L.; Swigris, J.J.; Brown, K.K.
- Abstract
Idiopathic pulmonary fibrosis (IPF) is a dreadful disease that lacks adequate therapy. A number of treatment trials have been performed and have utilized a variety of primary efficacy endpoints. Endpoints that provide the most useful efficacy information are clinical endpoints that are directly related to how a patient feels, functions or survives. Unfortunately, there are no properly established patient-reported outcome measures or measures of functional status in IPF, making survival the most robust primary efficacy endpoint. Clinically meaningful events such as hospitalization can also provide important efficacy information. The use of non-validated surrogate endpoints as primary outcome measures often leads to uncertainty when interpreting trial results.
- Subjects
IDIOPATHIC pulmonary fibrosis; HOSPITAL care; CLINICAL trials; THERAPEUTICS; HOSPITAL patients; LUNG diseases
- Publication
QJM: An International Journal of Medicine, 2012, Vol 105, Issue 11, p1043
- ISSN
1460-2725
- Publication type
Article
- DOI
10.1093/qjmed/hcs066