December 2022 • PharmaTimes Magazine • 12
// CLINICAL TRIALS //
Addressing diversity and inclusion in clinical trials is a story of our times
Recruitment in clinical trials needs modernising through the fresh lens of diversity and inclusion. But to take appropriate steps forward, we need to understand why representation matters and acknowledge the gaps that exist in clinical research.
Clinical trials can lead to improved patient outcomes – more time with loved ones and access to innovative treatments. Therefore, accessibility and choice to participate in research is crucial for everyone. In addition, an enriched and diverse research population allows us to better understand how treatments affect different groups of people, making medicines individualised to those who benefit most.
There have been some improvements in the diversity of trial patients during COVID-19, but we need to do more across all disease areas. We must ensure under-represented groups including ethnic minorities, people with disabilities, deprived communities, women and hard-to-reach groups are not only included in trials, but representative of the populations each trial serves to help.
Ultimately, we need to work closer with patients and their communities and be willing to collaborate to find new solutions that lessen the burden of disease and treatment costs.
We also need to increase representation among those who recruit for clinical trials. When navigating new or difficult scenarios, it’s human nature to turn to individuals to whom we relate. This remains true for patients and their healthcare providers.
Patients are more comfortable speaking to HCPs that look like them or can relate to them culturally, ethnically or by having a similar experience. Until we have a truly diverse HCP population, we’ll never have a diverse patient population in clinical trials. Culturally diverse teams are key to building trust with wider patient groups, which can broaden education, widen knowledge and enable us to further help patients.
Recent research shows that there are at least nine barriers to diversity and inclusion in clinical trials, so, how are we breaking these down? One of the barriers is trial accessibility – both physically and societal. Typically, clinical trials are hosted in areas that exclude people in remote regions, which further excludes whole populations.
Many are unable to travel to these locations, therefore additional investment into reaching these groups is vital. One way we’re doing this is improving transport for wider geographical areas. Providing reimbursement for travel and care, clinical buses, translators, making trial materials culturally appropriate and partnering with patient advocacy groups, helps us to understand issues the wider patient population faces, while enabling them to participate in clinical research.
At Novo Nordisk we strive to work with patients, advocacy and research groups, local communities and healthcare providers to better understand barriers and find sustainable solutions to improve trial participation. As we begin to break barriers, we face new ones in their place but are dedicated to breaking these also.
If the pandemic taught us anything, it’s that people are impacted by disease and possible treatments differently, and we cannot overlook this any longer. As an industry, we need to take robust steps to address the gaps in clinical trial representation.
Avideh Nazeri is Vice President Clinical Development, Medical and Regulatory Affairs at Novo Nordisk UK. Go to novonordisk.co.uk