Diversity and inclusion in clinical trials: keeping up momentum

In 2022 the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act was presented as a call for industry to develop plans within clinical research that enrol more participants from underrepresented demographic and to provide subgroups, including age, race, ethnicity and sex. The bill requires enhanced data reporting on clinical trial participant demographics to provide resources to marginalised communities, to improve access and participation in clinical trials.

FDA commissioner Robert M Califf commented: “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

There have been some recommendations from the Food and Drug Administration (FDA) on how to action these diversity plans but there’s still a lot of progress to be made. According to IQIVIA’s ‘Global Trends in R&D 2023’, clinical trial diversity in the US has dropped to its lowest level in ten years. But diversity is not synonymous to just ethnicity.

Gender, sexuality, age, environmental conditions, underlying comorbidities and disabilities, and socio-economic background still fall short of consideration in trial and protocol design, despite them being major predictors of health outcomes.

Medicines work differently in different people, so it’s no surprise that trial participants need to reflect the population that is likely to be prescribed the treatment if it is approved in the future. In the end, this will not only help those who need the medication but also give healthcare professionals (HCPs) confidence to prescribe it.

There are several areas to consider when incorporating diversity plans into a trial.

For sponsors, considering the patient population ahead of protocol design is paramount. Conducting audience research to understand the real-world audience – their day-to-day lives, pain points, motivators and barriers to taking part in a clinical trial.

Looking beyond patients and understanding their influencers, such as caregivers and HCPs within their ecosystem, will also be key. Challenges from previous trials could also provide valuable insight about the audience and barriers to enrolment and retention that may influence draft protocol and study design.

At Havas Lynx Faze, we run protocol simulation sessions with patients and sponsors to understand a patient’s experience at every touchpoint, improving the trial design ahead of time and informing the strategy.

We need to look beyond clinical characteristics to assess patient ‘suitability’ for a trial. Understanding where patients live, their socio-economic status, job and family situation can make all the difference.

The location of sites, as well as the burden of visits and reimbursement, are all key considerations when designing a trial. Selecting sites in affluent areas or main cities is going to be a struggle for patients living in rural areas, especially if travel support is not provided. A working, single mother of three caring for her elderly parents may struggle to commit to regular in-person visits, so thinking about integrating telephone appointments where appropriate may help make a clinical trial a more realistic option.

We don’t need to know it all. Setting aside investment for bringing in experts to help can craft a more meaningful and targeted strategy to accelerate recruitment.

For example, Republica Havas Health is NMSDC-certified and has a proven trajectory of cross-cultural marketing and deeply rooted community relations. It has a dedicated focus to empower and build meaningful relationships with multicultural and LGBTQIA+ patients.
With collaboration, we can learn from each other and work towards bettering systemic healthcare inequalities.

Trial design and recruitment efforts may be the focus for increasing diversity, but it can’t stop there. We must consider where diversity could be impacted at every touchpoint in the trial:

• Are we providing trial materials in a language patients understand?
• Is the support enough to alleviate the burden on patients?
• Is the data we are collecting representative and useful for the whole patient population?
• Are the endpoints meaningful to the patients we are designing the medicine for?
• Are we running feasibility in a fair way that gives every potential site and investigator a chance to take part in the trial?