Wound Care Experts/FDA-Clinical Endpoints Project Update: Where We Are

In July 2014, the Association for the Advancement of Wound Care (AAWC) embarked on an initiative to strategically identify clinically meaningful, evidence-based, and patient-centered wound care endpoints to be considered by United States Food and Drug Administration (FDA) in the process of approving new products, devices, and therapies for wound care. Collaborating with the Wound Healing Society (WHS), the AAWC developed the Wound-care Experts/FDA-Clinical Endpoints Project (WEF-CEP) to address the fact that new and innovative treatments, devices, and drugs may not have complete healing as the focus and that other primary validated endpoints other than complete healing will promote more completion of clinical trials, reducing the time for discoveries to reach wound care patients. 

Over the past 3 years, through ongoing interaction with the FDA InterCenter Wound Healing Work Group (ICWHWG) the WEF-CEP team has conducted a far-reaching Clinician Survey with 628 participating wound care experts, completed an extensive literature review of wound care endpoints using the FDA criteria for a validated endpoint, published the clinical survey results, is in the process of publishing the research phase results, and is currently conducting a Patient Survey to augment the findings of the Clinician Survey. 

As part of the clinician survey, participants were asked to rate the relevance and importance of 28 endpoints involving clinical practice and patient outcomes. The Survey identified 22 endpoints that achieved a Content Validity Index rating of 75 or higher. Fifteen (15) of the 28 endpoints were evaluated for their relevance to improving quality of life. Of the 22 content-validated endpoints, 15 were chosen by a wound care expert team as highest priority and were included in the research phase of the project. Results from the Clinical Survey were published online in February 2017 and in print this past summer.¹

Throughout 2016, 5 teams of wound experts in researchj and clinical practice conducted research to identify supporting evidence in the literature for the 15 endpoints based on FDA criteria for qualifying a new clinical outcome assessment: reliability, clinical construct validity, capacity to detect change, and responder analysis.² This analysis confirmed clinical evidence is adequate to support all 15 of the high-priority endpoints based on FDA criteria. 

The WEF-CEP Patient Survey (based on the same patient-centered questions in the Clinician Survey) is underway to validate the clinician perception regarding endpoints that are important to patients. Participants include a broad group of clinical centers. Once completed, the results will be analyzed and shared with the FDA.

Owing to the importance of the research process and findings, the FDA asked the WEF-CEP team to present the WEF-CEP results as an educational seminar. On July 27, 2017, Dr. Driver, Dr. Gould, Dr. Gibbons, Laura Bolton, PhD, and Marissa Carter, PhD, addressed staff members from all 3 FDA departments responsible for the review and approval of wound care-related devices, biologics, and drug and development of guidance documents. The presentation was well received and underscored the need for a better understanding for use of validated endpoints in research, clinical practice, and new device approvals. 

The WEF-CEP team continues to work with the FDA to develop a communication plan for the project results. This includes developing clarification on best use of the endpoints already described in the 2006 Guidance Document for Industry³ and proposing the new validated endpoints. The ultimate goal is for clinicians, researchers, and the FDA to adopt these validated endpoints into clinical practice, trials, and the approval process for new technologies, devices, treatments, biologics, and drugs to improve clinical practice for people suffering with wounds by providing the right therapy for the right patient at the right time.

Dr. Driver is a professor (clinical), Department of Orthopedic Surgery, Brown University School of Medicine, Providence, RI; and Director, Translational Medicine, Wound Healing, Novartis Institutes for Biomedical Research, New Indications Discovery Unit, Cambridge, MA. Dr. Gould is an associate professor (clinical), Department of Medicine, Brown University School of Medicine; and Associate Medical Director, South Shore Health System Center for Wound Healing, Weymouth, MA. Ms. Dotson is Chair of the AAWC Public Policy Committee; and President, Healthcare Reimbursement Strategy Consulting, Bolivia, NC. Please address correspondence to: Lisa Gould, lgould44@hotmail.com