The overarching goal of WEF-CEP was to develop and publish evidence that shows the limited value of having only one primary clinical wound healing endpoint. This is true for clinicians, patients and research efforts. The goal was to prove that multiple wound healing endpoints have significant evidence to support their inclusion in clinical research trials. The single endpoint focuses our clinical trials and clinical practice on complete closure and ignores the step wise effort that is required to achieve wound closure. Consider, for example, managing patient pain related to wound care. Pain is a key patient and clinical concern with reliable, valid measures. However, products that reduce or alleviate patient pain related to wound care cannot be cleared by the FDA for the claim of pain reduction for use on any chronic or acute wound indication because pain reduction is not recognized as a primary outcome in clinical trials mandated by the FDA to qualify a product for marketing in the United States. This approval gap exists even though ample randomized controlled trials (RCTs) have reported evidence that interventions reducing wound-related pain shorten hospital stays and improve capacity to engage in daily activities.
After years of direct communication with the FDA, they have very recently agreed to discussing each endpoint BELOW with sponsors and researchers as long as they are coupled with specific validated measurement tools.
- Percent area reduction (PAR)
- Reduced infection
- Reduced pain / reduced analgesia use
- Increased physical function and ambulation
- Quality of Life
- Cost effectiveness
Now that WEF-CEP has achieved its goals it is time to grow even bigger. The FDA has invited the wound healing community to develop a Collaborative Community. CDRH has identified participation in collaborative communities as a strategic priority for 2018 to 2020. There are at least 9 other medical indications-communities that are part of this program.
A Collaborative Community is a continuing forum in which private- and public-sector members, which can OFFICIALLY include the FDA, work together on medical device challenges to achieve common objectives and outcomes. The community is encouraged to have broad representation and can include diverse, relevant organizations and individuals impacted by the specific overall interest, in our case wound care. For example, patients and care-partners, academics, health care professionals, payers, federal and state agencies, international regulatory bodies, manufacturers and developers should be considered as part of a Collaborative Community.
The charter can exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts. Collaborative Communities may develop for a number of reasons. Ultimately, Collaborative Communities seek to contribute to the improvement of areas affecting U.S. patients and public health.
The WEF-CEP team believes that a Wound Care Collaborative Community could accelerate the development of science-based solutions to policy challenges related to assuring the safety and effectiveness of many novel areas of medical device innovation.
In response to the FDA's invitation, we have submitted a draft Wound Care Collaborative Community charter to the FDA and look forward to working with WHS as a charter member. For questions regarding WEF-CEP or the Wound Care Collaborative Community please contact Dr. Vickie Driver (firstname.lastname@example.org) or Dr. Lisa Gould (email@example.com).