Dr. V. Driver, Dr. Lisa Gould, P. Dotson
In July 2014, the AAWC embarked on an initiative to expand the clinical endpoints considered by FDA in the approval process of new products, devices and therapies for wound care. Collaborating efforts with the Wound Healing Society, the AAWC and WHS developed the Wound-care Experts/FDA-Clinical Endpoints Project [WEF-CEP] to strategically identify clinically meaningful, evidence-based and patient-centered wound care endpoints that are relevant for clinical research and trials. The goal of WEF-CEP is to work with FDA to expand the list of acceptable primary endpoints, recognizing that new and innovative treatments, devices and drugs may not have complete healing as the focus. Furthermore, validated endpoints other than complete healing will promote more completion of clinical trials, reducing the time for discoveries to reach our patients.
Over the past three years, through ongoing interaction with the FDA InterCenter Wound Healing Work Group [ICWHWG], the WEF-CEP team has conducted a wide reaching Clinician Survey with 628 participating wound care experts, completed an extensive literature review for 28 wound care endpoints using the FDA criteria for a validated endpoint, published the clinical survey results, is in process to publish the research phase results and is currently conducting a Patient Survey to augment the findings of the Clinician Survey.
The WEF-CEP process involved surveying clinicians to gather feedback on 28 literature-based wound care clinical and patient-centered endpoints. Participants were asked to rate the relevance and importance of these endpoints to clinical practice, patient's lives and clinical research. The Survey identified 22 endpoints which achieved content validity with a Content Validity Index (CVI) of >75 or higher. Fifteen of the total 28 endpoints were evaluated for their relevance to improving quality of life. Of the 22 endpoints that were content validated, 15 were chosen by a wound care expert team as highest priority and were then placed in the research phase of the project.
Results from the Clinical Survey were published on-line in February 2017 and in the July/August issue of Wound Repair & Regeneration.
Throughout 2016, five teams of wound experts in research and clinical practice conducted the research phase of the project. These dedicated people, all volunteers, evaluated the literature for data based on FDA criteria for qualifying a new clinical outcome assessment: reliability, clinical construct validity, capacity to detect change, and responder analysis. This analysis confirmed there is adequate clinical evidence to support all 15 of the high priority endpoints based on FDA criteria.
In 2017, the WEF-CEP developed a Patient Survey, based on the same patient-centered questions in the Clinician Survey, with some wording modifications for layperson use, with the objective to validate the 'perceptions' of the clinicians regarding endpoints that are important to patients. This IRB approved Patient Survey is currently underway and will involve participation from a broad group of clinical centers and sites to recruit patients and in some cases, patient caregivers, to take part in the Survey. Once completed, the results will be analyzed and shared with the FDA.
Due to the importance of the research process and findings, the FDA asked the WEF-CEP team to present the WEF-CEP project as an educational seminar. On July 27th, 2017, Dr. Vickie Driver, Dr. Lisa Gould, Dr. Laura Bolton, Dr. Gary Gibbons and Dr. Marissa Carter presented the impact of wounds on patients' lives and the health system, as well as the process that WEF-CEP utilized to validate wound care endpoints that are relevant to clinical practice and patients' lives. Staff members from all three FDA departments responsible for the review and approval of wound care related devices, biologics and drug and development of guidance documents attended. The presentation was very well received and underscores the need to work with our stakeholders, to help them understand the challenges that are specific to wound care and to identify areas of similarity with other disciplines.
The WEF-CEP team is continuing 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 Industry 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. By working together we can build more robust clinical trials that address gaps in the evidence. The ultimate goal is to improve clinical practice for people suffering with wounds by providing the right therapy for the right patient at the right time. This requires that we all work together – the WEF-CEP project exemplifies one way to achieve that goal.
The AAWC and WHS and all the interdisciplinary wound care experts that have been involved in this extensive initiative have been instrumental in defining and validating clinically meaningful and measurable endpoints for wound care research, clinical practice, and to evaluate the impact of treatments on patient's lives.