12 - CLINICAL TRIALS: A reflection of society

Making clinical research more accessible to all has long been advocated by regulators and patient advocacy groups to ensure clinical trial patients represent the intended intervention’s target population accurately.

Global regulatory agencies have published numerous guidance documents encouraging enrolment diversity in recent years, and these and other collaborative initiatives have certainly helped to improve awareness in order to increase the ethnic and racial diversity of clinical trial participants.

There is still much work to do, however, if we are to make clinical research participation truly inclusive to everyone, including people with physical impairments, learning difficulties, neurodivergent individuals, the LBGTQ+ community and beyond.

For biopharma companies to tackle diversity, inclusion and equality (DE&I) in clinical trials effectively, they and their partners must consider the needs of these patients well before a study has even launched.

A top-down commitment to DE&I should be reflected in study protocols, looking beyond the obvious differences in ethnicities and geographies to include people with any number of physical or mental conditions that can limit access to clinical research.

Specific strategies to recruit these patients into clinical studies – and retain them throughout the duration – should be designed around patient needs and preferences to ensure the study is constructed in a way to accommodate everyone.

As with all studies, how the trial is conducted has significant bearing on overall patient recruitment and retention. As such, it is critical that trial strategists consider the entire patient journey when designing studies, from how patients will first learn of the study, to how they will be monitored throughout.

For example, trial websites should be compatible with accessibility tools and patient-facing literature may need to be made available in Braille or large print for visually impaired patients or translated into other languages to accommodate non-native speakers.

Similarly, trial-eligible patients in emerging regions may lack access to the internet or even a primary healthcare provider, but they most likely have access to mobile telephones and SMS technologies as an alternative for delivering trial information.

Neurodiverse patients may prefer information via video or infographics, or need help reducing sensory overload in clinical environments. The natural point is to minimise the burden to patients by meeting them wherever they are, making trial participation more accessible and inclusive.

A commitment to DE&I in the early planning stages provides an opportunity to bring in vendors or grassroots patient advocacy groups to solicit their trial design input. Outside organisations almost always bring the patient perspective to the forefront, ensuring that proposed studies reflect the needs of patients with particular conditions. For people with a mobility limiting condition, such as multiple sclerosis, in-person visits to a physical site might not be practical, but including a concierge, telehealth or home nursing option as part of the study may enable participation.

Collaborating with both traditional and non-traditional patient advocacy groups to design clinical trials around patient preference is just one component of improving DE&I in clinical trials. Biopharma companies should select partners who not only understand the importance of improving DE&I in clinical research, but know how to operationalise it as well.

At Advanced Clinical, we are proud to have established inclusivity workstreams – including one for clinical trial recruitment – that look beyond ethnicity to create a clinical research framework around what patients want, not just what regulators require.

Ultimately, if we are going to be equitable, we must include everyone, and that means reimagining and retooling both our perspectives and our processes to make clinical research more inclusive and accessible to everyone.

A reflection of society

Trial blazers