Clinical trials have a diversity problem. Whichever stats you look at, minorities are hugely underrepresented in health research. (source)
Black Americans = 13 % of US population -> 5% of US trial participants
Latinx = 19% of US population -> 1% of US trial participants
This isn’t just a US problem. The same lack of representation of ethnic minorities is present in trials conducted in all of the most research active countries (which are largely majority white). (source)
It’s important to say that this isn’t about representation for representation’s sake. A lack of diversity has a number of impacts on the efficacy of clinical trials at their most fundamental level:
In November 2020 the FDA issued guidance on “Enhancing the Diversity of Clinical Trial Populations” (source). This speaks to the importance of both trial design and recruitment methodology, and it’s definitely true that these are two sides of the same coin.
There has also been excellent work done by Shaun Treweek and the team at Trial Forge with their INCLUDE ethnicity framework (source).
We decided to take action given we are directly involved in recruiting patients and we’ve seen first hand the difficulties and strengths of different recruitment strategies. Incorporating expert feedback from our Participant Advisory Board, we've put together a 5 step strategy to deliver on diversity:
Understand the patient population and design with them at the forefront: we work with our partners to understand what a patient population looks like, and help them to design the trial with this in mind. This can include anything from ensuring that the eligibility criteria aren’t too restrictive, to ensuring that trials are less burdensome for patients (e.g., fewer in-person visits, or simplified ePRO).
Speak the patient’s language: participants need to understand what research is and what a trial will involve for them. We work with our Participant Advisory Board, made up of experienced patient advocates, doctors, and real trial participants, to carefully craft all patient facing materials. This includes translating materials into multiple languages!
Work with trusted voices: it’s important that communities are engaged by voices and figures that they know and trust. We often work with relevant organisations such as patient advocacy or faith groups.
Use the right channels: not everyone should be engaged the same way. For example, people attending clinics in person are likely to skew dramatically by age and ethnicity. Our primary care product is uniquely suited for recruiting a representative population, given they are by definition representative of the population at large, and means that we can reach diverse participants no-one else can. Social media is also effective for going direct to patients who may be less accessible.
Feedback in real-time: there’s no one-size-fits-all approach to delivering on diversity. We constantly assess the trial cohort and can rapidly adjust our recruitment strategy accordingly, to ensure that we deliver for our partners.
One of the more dispiriting things we’ve heard since setting up Lindus Health, is that for some trials “diversity'' is still justa buzzword, and that eligibility criteria are sometimes deliberately designed to be exclusionary. It’s very easy for one trial to try to justify this on the basis that, for example, they don’t want complicated co-morbidities. But the population impact of this is huge.
Fortunately this hasn’t been the case for any of the teams that we’ve worked with so far, who have all been actively trying to improve the diversity of their trial cohorts, recognising that that is the only way to find treatments that work. At Lindus Health we want to work with partners who are committed to our mission, to make health research accessible to everyone, everywhere.
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