Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies

William H. Eaglstein, Robert Kirsner, Martin C. Robson

Research output: Contribution to journalArticle

23 Citations (Scopus)

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 languageEnglish
Pages (from-to)793-796
Number of pages4
JournalWound Repair and Regeneration
Volume20
Issue number6
DOIs
StatePublished - Nov 1 2012

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Skin Ulcer
Drug Approval
Neoplasms
United States Food and Drug Administration
Mortality
Signs and Symptoms
Biomarkers

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 journalArticle

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