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Imaging endpoints in clinical trials
Author(s) -
Garhofer G.
Publication year - 2017
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2017.02354
Subject(s) - clinical trial , surrogate endpoint , medical physics , medicine , optical coherence tomography , clinical endpoint , drug development , intensive care medicine , clinical study design , drug trial , pathology , radiology , drug , psychiatry
Summary Clinical drug trials usually rely on primary endpoints that are well‐described direct measures of patient benefit or are closely related to clinical outcomes such as visual field testing. However, there is a lack of short‐term, easy to measure, highly reproducible endpoints predictive for visual acuity outcomes that would qualify as sufficiently predictive variables for patients′ benefit in clinical trials. This of special importance for the follow up of slowly developing diseases, which requires long‐term studies with large sample sizes. The rapid progression in the development of in‐vivo imaging techniques offers now new and exiting possibilities to assess human anatomic or physiologic information in unprecedented high resolution. Thus, the use of these new imaging techniques such as optical coherence tomography as possible endpoints in clinical phase III trials has been widely and controversially discussed. This talk aims to summarize the potential and limitations of modern imaging techniques to serve as surrogate parameters to substitute for clinical endpoints in ocular drug development.