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.
Product Clinic #3: Embedding software engineering efficiency hacks into our clinical trial platform
Heard of dogfooding? No, not feeding your pet! The practice of using your own software to understand how it performs in the real world and catch any issues. Read about this and other software engineering hacks we are using to build better products.
A Fireside Chat with Paul Wicks: How can we make clinical research for digital therapeutics more patient-friendly?
Digital Therapeutics are still a relatively new treatment area and there is a lot to learn about conducting clinical research on them. Find out how Paul Wick's, Digital Health expert, thinks research companies can put the patients first.
Product Clinic #2: Using feedback loops to build better products
Lindus Health's objective is to build better products that hit non-negotiable clinical standards and challenge outdated conventions. How do we do this? Read more here
Why I joined Lindus Health? Ece Kavalci, Machine Learning Engineer
Working towards a good cause. Innovative approaches to solving problems in clinical trial design. Every contribution is valued.
Why I joined Lindus Health? Van Zyl Engelbrecht
The mission to accelerate clinical trial. The focus on making clinical research more patient-centric. The ability to support innovative health companies bring their product to market at a lower cost.
Product Clinic #1: Turning boring technology into exciting products
Don't be put off by the blunt use of the word "boring" to describe our technology. It's one of our guiding principles allowing us to make rapid progress while maintaining high quality standards. Read more here.
James Lind and the Mafia
The story of how James Lind's trial for scurvy led to the formation of the mafia.
What actually improves diversity in clinical research?
We’ve all seen the evidence of ethnic minority underrepresentation but what is actually going to have an impact in the future? Read Lindus Health’s action plan here
Vaccine Trials and Tribulations
Read co-founder Meri’s experience of a Covid-19 vaccine trial that left him frustrated (but vaccinated), and led to the creation of Lindus Health.
Stagnation, Drugs and Eroom's law
Why does the cost of clinical trials continue to increase? Meri Beckwith, Lindus Health co-founder discusses why stagnation has prevailed and how technology is the answer
Cure Scurvy with this one weird trick…! Doctors hate him
In 1747 James Lind conducted the first clinical trial, proving that oranges and lemons were a cure for scurvy. Given that we’re named after him we felt it was about time we wrote a post about the history of scurvy, Lind, and the first ever clinical trial! We believe that in 100 years current health outcomes will seem just as ridiculous and intolerable as 50% of sailors dying of scurvy seems now, and that’s why we’re named Lindus Health.
Why I joined Lindus Health? Luke Twelves, Medical Lead
To help make trials more accessible to patients and clinicians. To help bring novel and innovative treatments to the frontline of care faster. To stretch myself and work as part of a really exciting team.
A success story: Lindus Health recruiting prediabetes patients for the ASPIRE-DNA clinical trial
Lindus Health used its multi-channel strategy to accelerate DnaNudge's trial recruitment. Read more about the challenges they faced and our results here.
Lindus Health launches with $5m seed round to revolutionise health research
Lindus Health publicly launched today, announcing $5m in seed funding from leading technology and healthcare investors including Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks and Amino Collective.
Why I joined Lindus Health? Nik Haldimann, CTO
A worthy mission. Personal challenge & growth. To create a dream environment for engineers.
Optimising trial recruitment with our Primary Care Network
Primary care organisations are responsible for patient care but are not yet set-up for research. What do we mean by Lindus Health’s Primary Care Network and what are its advantages? Learn how primary care can turbocharge your trial recruitment.