Navigating diversity and inclusion in clinical trials

Greg Plunkett, founder and CEO of contract research organisation (CRO) Accelagen, shares his company’s perspective on the importance of diversity in clinical trials and why the science of inclusion matters.

Returning from the BIO International Convention 2023 in Boston, Massachusetts, it was heartening to hear so much robust discussion on something we’ve been focusing on at Accelagen for many years: diversity and inclusion in clinical trials. From the impacts that a lack of diversity can have on medical science, to the ethics of enabling access to medicine that hasn’t been adequately trialled in diverse populations, the discussions were far-reaching and wide-ranging.

For some time, regulatory bodies and ethics committees representing healthcare programs globally have lamented the lack of inclusivity and diversity when conducting clinical trials. Australia is not immune to this scrutiny, and nor should we be. As one of the fastest-growing clinical trials markets in the world, this is a conversation we must continue to have.

For Australian-based clinical trials, we believe that diversity and inclusivity are vital to not only ensuring representation from an ethics and equity standpoint, but also for the integrity of the science and findings themselves.

Understanding the science of diversity

A recent article released by the National Institute on Minority Health and Health Disparity reflects on the differences in disease symptoms and prognoses experienced by patients which can differ based on their gender, ethnicity, location and socioeconomic status. Historically, clinical trials sought to recruit male, Caucasian study participants, and shied away from enrolling a broader patient demographic. This approach, although no longer a consideration in today’s clinical trials, prevented researchers from gaining a true picture of the safety and efficacy of their new intervention.

It is also well documented that there are both subtle and significant differences in the pharmacokinetics, metabolic and cell structures of different ethnic groups. At a basic level, this differing genetic makeup can impact how the drug is metabolised, and therefore its overall bioavailability.

Diversity and access

While many assets, or drugs, are developed for the benefit of the masses, it is important for each clinical trial to pay attention to a diversity of participants. This is a client’s greatest opportunity to test the true efficacy of their product.

Thankfully, because of the diverse nature of our population here in Australia, we have a significant benefit over other popular clinical trial destinations with studies able to recruit participants from many different ethnic and social communities. However, more can always be done to level the playing field in science and research.

Many of Accelagen’s clients come from global overseas markets, including the US and Europe, where access to affordable health care may not be as straightforward as ours in Australia. The way we see it, this lack of access creates exclusivity, and exclusivity leads to inaccuracy.

Our local healthcare system is lauded as world-class, with state-of-the-art facilities and more equal access to quality health care than many other parts of the world. This accessibility and our hybrid healthcare system (virtual and in person, public and private) here in Australia directly impacts the quality of data that is then yielded in clinical trials.

Navigating diversity in clinical trials

In instances where clients are looking to gain diverse population data, there are fantastic checks and balances already in place throughout Australia’s healthcare and clinical research systems to support this. As a clinical trial partner, one way a company like ours can support this is by working with our partner facilities to recruit trial participants in languages other than English, to create a more inclusive environment and ensure trial participants are more representative of the true population.

An example of Accelagen’s involvement in a diverse and inclusive trial is a recent study with US-based Kiora Pharmaceuticals — a first-in-human trial for individuals living with the rare inherited condition retinitis pigmentosa (RP), based out of the Royal Adelaide Hospital in South Australia. In addition to recruiting individuals with little to no light perception, having a focus on diversity and accelerating accessibility meant that we prioritised communications and recruitment for this trial in braille, in addition to languages other than English.

A diverse future for clinical research

Clinical research is about far more than just testing a new therapy in a group of trial participants. It is about creating measurable improvements for people’s health and wellbeing that will impact generations to come. This can only be done by ensuring access to clinical trials by diverse populations and holding a vision for the future where humans thrive and health is ubiquitous.

While clients are naturally attracted to Australia’s diverse population for clinical study data, CROs need to also make a point to work creatively with clients to ensure they’re able to gain the most inclusive and representative populations, and, therefore, data possible.

This includes developing strategies to reach and attract study participants from rural areas, as well as those from culturally and linguistically diverse backgrounds. In practical terms, this means providing transport, accommodation and coordinating travel for patients from locations outside of city centres where most clinical research facilities are located. It also means working with trial facilities outside of city centres, when possible, including centres in regional and remote areas to ensure a more patient-centred approach.

The diversity and inclusivity of a study can be derived from explicit data reporting on the demographics of participants involved, including things like ethnic origin. This creates clarity and transparency of results and representation in the data, and puts Australia in the box seat to deliver even more potentially first-time treatments for underserved conditions. And we know this creates hope and possibility for many.

Top image credit: iStock.com/VioletaStoimenova