By Nico O’Kuinghttons, Vice President, Research & Analytics, Tissue Analytics, a Net Health Company
The past year has vividly highlighted the troubling impact the lack of diversity and equity in our nation has on every facet of life. Clinical trials are no exception. Black and Latinx populations constitute about 32% of U.S. residents, but only make up 6 to 8% of all participants in federally-funded clinical trials.1
We’re slowly beginning to find ways to ensure clinical trials are more inclusive. However, simply seeking to expand trial participation by race is not enough to provide a representative population of trial participants. We’re also missing a vitally important demographic – elderly patients and those with chronic comorbidities. Yes, a controversial population to address and enroll in clinical trials, but without it, we are missing the complete picture of the efficacy and promise of new products and services to those who need them most.
Clinical trials must represent all patient populations that will utilize and could benefit from medication or therapy to provide useful findings. How can we know if a therapy works for an elderly patient with diabetes if it’s only been tested on a healthy younger person? We can’t.
While we must have a focus on driving diversity in order to get a representative population of patients to participate in trials, that emphasis in itself will also help to ensure we include those patients that typically make up the most vulnerable populations in our healthcare system. Here are some vital steps the healthcare industry can take to reach that goal:
Don’t be afraid of complex wounds. Patients with pressure injuries, diabetic foot ulcers, and other wounds often have chronic comorbidities such as diabetes, heart disease, or other vascular conditions. Clinical trials that focus on patients with easy-to-treat wounds so that their results are more promising skew real-world outcomes and don’t help the very populations that most need wound care solutions.
Industry and regulatory agencies must collaborate to redefine how success is measured. The success of a pending therapeutic in traditional clinical trials is based on “complete healing” or at least significant improvement – this excludes other means that demonstrate efficacy. Patients that represent the population that will be using a product or therapy can be complex, have comorbidities or have a worsened condition due to minimal access to care. Their wounds will be difficult to heal. We all want to see patients completely heal but that isn’t always a clinical possibility when it comes to a complex wound such as a pressure injury or diabetic foot ulcer. It is imperative for regulators and industry partners to address new measures to convey how success is measured.
Make it easy for people to participate in a trial, wherever they are. We need people in trials who are in homes, being cared for by a loved one, in a nursing home or skilled nursing facility. We must make it easy for the caregivers who may need to help a participant take part in a trial. Mobile technologies, specifically smartphones, are easy to use, provide data security, and help ensure a broad range of people can take part in a clinical trial.
It’s time to take an honest look at clinical trials for wound care and ask ourselves as an industry if we are ready for change. If our goal is to help patients, we need to be bold in our approach to research and redefine our criteria for participation and success.
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L. Konkel. Racial and Ethnic Disparities in Research Studies: The Challenge of Creating More Diverse Cohorts. Environ Health Perspect. December 2015. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670264/.