By Richard Veal and Raymond Huml
In July, we celebrated Disability Pride Month, acknowledged every year to mark the anniversary of the signing of the Americans with Disabilities Act on July 26, 1990. And while we’ve come a long way in making society more inclusive for people with disabilities, we still have a long way to go – especially in healthcare. And as we look at what gaps remain in health equity, it’s impossible not to recognize the health disparities faced by people with disabilities.
Research has shown that people with disabilities have twice the risk of developing conditions such as depression, asthma, diabetes, stroke, obesity, and poor oral health, and that some people with disabilities die up to 20 years earlier than those without disabilities.1 One population-based study from 2022 found that people with disabilities involving mobility and activity limitations had significantly higher rates of ovarian, prostate, and colorectal cancer, as well as non-Hodgkin’s lymphoma, than people without disabilities, and were significantly older on average than people without disabilities when diagnosed with those four types of cancer.2
But what can drug manufacturers do to address these challenges?
The Value of Inclusive Clinical Trials
We know that one crucial factor in ensuring health equity is making sure that people from underrepresented groups are included in clinical research, so that the medications that are approved will be safe and effective for those groups.
But enrolling patients from underrepresented populations can be difficult, especially in cases where the target patient population is small, such as in rare disease, some cancers, and advanced or specialty therapeutics (such as gene or cell therapy and other personalized medicines). This may be especially true when it comes to enrolling people with disabilities, due to challenges such as lack of accessible transportation, lack of accessible study materials, financial limitations, and more. Underrepresentation of disabled people in clinical research also deprives scientists, researchers, and clinicians from learning about and interacting with this patient population.
Despite these challenges, it’s arguably even more important for manufacturers working on specialty drugs, advanced therapeutics, and complex disease areas to ensure that people with disabilities enroll, because the patient population may already be so small that not including such patients isn’t a viable option.
A decade ago, most drug manufacturers were focused more on drug approval rather than inclusive and accessible clinical trials. The old mindset was that they wanted their investigational medication to have the highest possible chance of securing FDA approval, so they might use inclusion/exclusion criteria that was most likely to ensure “smooth sailing,” which meant excluding people who might not benefit from the drug the most, might not be likely or able to comply with trial protocols, etc.
Today, we’re in a climate where patients and other stakeholders have higher expectations, and issues like environmental consciousness, social responsibility, and embracing diversity are being prioritized. And the companies who won’t – or can’t – acknowledge those priorities and act accordingly are at a disadvantage. And not just in terms of the possibility of losing favor with the patient/consumer market; trial investigators, sites, physicians, and others want to align themselves to drug companies who look at what’s good for people, not just what’s good for the bottom line.
Ask the Experts
For those drug manufacturers who are ready and willing to adopt this new mindset, there are several tactics they can employ to help ensure that clinical trials are accessible for people with disabilities. Developing accessible materials (large-print educational information for the visually impaired, videos with captions for the hard of hearing, etc.), reducing transportation burden through decentralized clinical trials and remote check-ins, and developing inclusion/exclusion criteria that does not inherently exclude people with disabilities are all good ideas.
Beyond these changes, work with your team to come up with creative solutions. A 2022 article in the International Journal of Environmental Research and Public Health makes several valuable suggestions, including using population-based datasets that include disability identifiers; advocating for legislation and healthcare policies that address and reduce systemic barriers; and supporting funding opportunities calling for high-quality research designed to develop and test the effectiveness of interventions designed to reduce cancer disparities in people with disabilities.4
But perhaps the most important thing that drug companies can do to ensure that people with disabilities are included and represented and that their trials are accessible is ask the experts. Not the MDs, the PhDs, or the CEOs. The experts in disability are the people living with those conditions and the families, caregivers, and loved ones who experience the day-to-day of it by their side. Ask a parent of a child with a rare disease what inclusion/exclusion criteria is actually reasonable and possible based on their child’s abilities and limitations; ask a patient advisory board or an advocacy group what they need. Until we flip the paradigm and realize that it’s the patients who are the experts, we’re not getting to the root of the issue.
Syneos Health® is in a unique position to help drug manufacturers achieve – and communicate – this paradigm shift in the right way. With offerings including corporate communications and public relations, clinical research and validation, medical affairs, and outsourced deployment solutions, we have the right experts and the right experience across the board to help companies navigate challenging issues successfully.
Reducing health disparities among people with disabilities is not something we can achieve overnight. What it requires is collective, consistent effort across the healthcare industry – from drug developers to physicians to C-suite decision makers. It requires giving patients a voice and acting according to what we learn from them. It requires a commitment to making our healthcare system assessable and inclusive, and a recognition that people with living with disabilities are entitled to the same quality healthcare and quality of life as anyone else facing illness or disease.
About the author:
Richard Veal, MBA, is the EVP, Managing Director, of GENICOS, powered by Syneos Health; and Raymond Huml, is the Vice President of Medical and Scientific Strategy, Head of the Rare Disease Consortium, Syneos Health Clinical Solutions and Founder and Executive Sponsor of the Persons with Disabilities Employee Resource Group at Syneos Health.
References:
1.https://www.who.int/news-room/fact-sheets/detail/disability-and-health
2.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9367955/#:~:text=According%20to%20a%20population%2Dbased,lymphoma%20than%20people%20without%20disabilities
3.https://www.mda.org/disease/duchenne-muscular-dystrophy#:~:text=Duchenne%20muscular%20dystrophy%20(DMD)%20is,four%20conditions%20known%20as%20dystrophinopathies
4.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9367955/#:~:text=According%20to%20a%20population%2Dbased,lymphoma%20than%20people%20without%20disabilities
