Abstract
The rising costs of caring for chronic cutaneous ulcers (CCUs) and recent appreciation of the mortality of CCUs have led to consideration of the reasons for the failure to have new drug therapies. No new chemical entities to heal CCUs 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 CCUs 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 CCUs. And the difference is quite striking. While there is only one end point for CCUs, 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 CCUs. For example, making tumors smaller is an acceptable end point, but making CCUs smaller is not and improvement in the signs and symptoms of cancer is an acceptable end point for cancers but not CCUs. As CCUs carry a prognosis and mortality rate worse than many cancers, we believe a reconsideration of end points for CCUs is highly warranted.
| Original language | English |
|---|---|
| Pages (from-to) | 793-796 |
| Number of pages | 4 |
| Journal | Wound Repair and Regeneration |
| Volume | 20 |
| Issue number | 6 |
| DOIs | |
| State | Published - Nov 1 2012 |
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ASJC Scopus subject areas
- Dermatology
- Surgery
Cite this
Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies. / Eaglstein, William H.; Kirsner, Robert; Robson, Martin C.
In: Wound Repair and Regeneration, Vol. 20, No. 6, 01.11.2012, p. 793-796.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies
AU - Eaglstein, William H.
AU - Kirsner, Robert
AU - Robson, Martin C.
PY - 2012/11/1
Y1 - 2012/11/1
N2 - The rising costs of caring for chronic cutaneous ulcers (CCUs) and recent appreciation of the mortality of CCUs have led to consideration of the reasons for the failure to have new drug therapies. No new chemical entities to heal CCUs 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 CCUs 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 CCUs. And the difference is quite striking. While there is only one end point for CCUs, 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 CCUs. For example, making tumors smaller is an acceptable end point, but making CCUs smaller is not and improvement in the signs and symptoms of cancer is an acceptable end point for cancers but not CCUs. As CCUs carry a prognosis and mortality rate worse than many cancers, we believe a reconsideration of end points for CCUs is highly warranted.
AB - The rising costs of caring for chronic cutaneous ulcers (CCUs) and recent appreciation of the mortality of CCUs have led to consideration of the reasons for the failure to have new drug therapies. No new chemical entities to heal CCUs 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 CCUs 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 CCUs. And the difference is quite striking. While there is only one end point for CCUs, 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 CCUs. For example, making tumors smaller is an acceptable end point, but making CCUs smaller is not and improvement in the signs and symptoms of cancer is an acceptable end point for cancers but not CCUs. As CCUs carry a prognosis and mortality rate worse than many cancers, we believe a reconsideration of end points for CCUs is highly warranted.
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UR - http://www.scopus.com/inward/citedby.url?scp=84868524099&partnerID=8YFLogxK
U2 - 10.1111/j.1524-475X.2012.00849.x
DO - 10.1111/j.1524-475X.2012.00849.x
M3 - Article
VL - 20
SP - 793
EP - 796
JO - Wound Repair and Regeneration
JF - Wound Repair and Regeneration
SN - 1067-1927
IS - 6
ER -