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Food and Drug Administration ( FDA ) drug approval end points for chronic cutaneous ulcer studies
Author(s) -
Eaglstein William H.,
Kirsner Robert S.,
Robson Martin C.
Publication year - 2012
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1524-475x.2012.00849.x
Subject(s) - medicine , end point , food and drug administration , surrogate endpoint , intensive care medicine , clinical trial , clinical endpoint , drug administration , quality of life (healthcare) , drug , pharmacology , geometry , mathematics , nursing
The rising costs of caring for chronic cutaneous ulcers ( CCU s) and recent appreciation of the mortality of CCU s have led to consideration of the reasons for the failure to have new drug therapies. No new chemical entities to heal CCU s have been approved by the Food and Drug Administration ( FDA ) in over a decade, in part due to an inability to reach the FDA accepted end point of “complete wound closure.” The frequent failure to reach the complete closure end point brings forward the question of the relevance of other healing end points such as improved quality of life, or partial healing. Because CCU s carry a prognosis and mortality rate worse than many cancers, it is reasonable to compare the FDA trial end points for cancer drug approval with those for CCU s. And the difference is quite striking. While there is only one end point for CCU s, there are five surrogate and three direct end points for cancers. In contrast to cancer, surrogate end points and partial healing are not acceptable for therapies aimed at CCU s. For example, making tumors smaller is an acceptable end point, but making CCU s smaller is not and improvement in the signs and symptoms of cancer is an acceptable end point for cancers but not CCU s. As CCU s carry a prognosis and mortality rate worse than many cancers, we believe a reconsideration of end points for CCU s is highly warranted.