Should We Revisit Accepted Endpoints In The Studies Of Modalities For Wound Healing?
- David G. Armstrong DPM PhD MD
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Despite the high cost and potentially grave complications of chronic cutaneous ulcers, the Food and Drug Administration (FDA) has not approved a new drug therapy for such ulcers in over a decade. Indeed, the mortality rate of chronic ulcers can eclipse that of many cancers. This begs the question: Should we apply the endpoints researchers use for drugs in cancer studies in a similar fashion to studies of modalities for chronic cutaneous ulcers?
Bill Eaglstein, MD, Rob Kirsner, MD, PhD, and Marty Robson, MD recently published a study in Wound Repair and Regeneration exploring this concept.1 The authors postulate that the lack of new drugs for ulcers is partially attributed to the inability to reach the FDA’s sole accepted endpoint of “complete wound closure.” The study points out that while there is only one endpoint for studies for chronic cutaneous ulcers, cancer studies have five surrogate and three direct endpoints. Eaglstein and colleagues note that for cancer, making tumors smaller and improvements in signs and symptoms are acceptable endpoints, but chronic cutaneous ulcers have no comparable endpoints.
In addition to complete wound closure, what additional primary endpoints should the FDA be using for chronic cutaneous ulcers? The reduction of wound size (just like reduction of tumor size) is a great endpoint that could shorten the time to drug discovery and device development.
1. Eaglstein WH, Kirsner RS, Robson MC. Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies. Wound Rep Regen. 2012; 20(6):793-796.
This blog has been adapted with permission from a blog that previously appeared at http://diabeticfootonline.blogspot.com/2012/11/should-we-treat-wound-hea... .