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health inequity at a glance

An anticonvulsant medication used primarily for the treatment of epilepsy and neuropathic pain, that is showing rare, but serious adverse dermatological reactions with more Asian patients than with any other ethnic group; clinical trials with racially mixed populations with noticeable differences in drug efficacy measured by survival between the overall population versus black people to such an extent that that drug ultimately was only approved for the black population; and finally, the early discovery of very low efficacy rates of a drug for the treatment of the Irritable Bowel Syndrome for men, leading to a change in indication and was approved for use by women only. When reading about these and other adverse reactions caused during the clinical testing phases for devices and drugs, we cannot but wholeheartedly agree with the necessity of advancing equity, diversity, and inclusion in clinical trials, and beyond. It does not solve the challenges of health inequity across the globe, but it is a step in the right direction. We like to address the very subtle correlation between the level of diversity and equity in clinical trials and the success rate when it comes to awareness, acceptance, and hence potential access to health, i.e., health equity for these enrolled patients.

diversity, equity and inclusion considerations should be integrated across the entire health product lifecycle where possible

Before we continue, let’s agree on the definition of “health equity” or the lack thereof. According to the WHO, “Equity is the absence of unfair, avoidable or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically or by other dimensions of inequality (e.g., sex, gender, ethnicity, disability, or sexual orientation)” Furthermore, the WHO states that “health is a fundamental human right. Health equity is achieved when everyone can attain their full potential for health and well-being”, and – we add – has access to medication that has proven its efficacy for the given target population.

Back to clinical trials as a first step in the right direction: in a previous blog, we used the quote “disease and illness do not discriminate”. Ethnicity, race and age, race, comorbidities, concurrent medications, social determinants of health and environmental factors, do determine how certain conditions and medical treatments affect us.

overcoming challenges: promoting diversity in clinical trials

For a while now, Diversity, Equity and Inclusion in Clinical Trials have been high on the agenda of regulatory authorities (e.g. FDA) and other recognized forums (e.g. IMDRF) who have issued relevant guidance documents (see also our blog on evolution on regulatory affairs on life sciences) and other guiding principles. Also, in December 2022, US Congress signed into law FDORA (Food and Drug Omnibus Reform Act) requiring diversity plans for all device and Phase 3 drug studies. It also requires that the FDA start publicly reporting diversity metrics in 2024. Something that many sponsors are struggling with as mentioned during the last RAPS conference in Montreal in October 2023.

Nevertheless, certain groups of patients remain underrepresented in global clinical trials. Why is that? After all, most global pharma and medical device companies do understand this sense of urgency and necessity to recruit a diverse population, but how can they overcome certain challenges that impact the efficacy and reliability of real-world evidence data? After all, they are recruiting patients who are simply not representative of the treatment’s true intended patient population in the market. Isn’t this a costly missed opportunity?

Let’s address just one of the many challenges: for certain demographics, there is fear, mistrust and a sense of taboo impacting clinical trial participation. This fundamental mistrust can be baked into the culture’s norms and values and lead to the patient’s reluctance to participate. The absence of relevant information that is culturally appropriate can also be a reason for a patient’s denial to participate in a trial. Creating awareness and buy-in of these candidate patients requires a culturally acceptable patient-centric approach, by creating an experience that fully resonates with the targeted audience.

An admirable example of achieving this buy-in is offered by Alzheimer Tea Houses, an initiative of Alzheimer Europe, the umbrella organization of 41 national Alzheimer’s associations from 37 European countries. Alzheimer Tea Houses are “a meeting place for Turkish and Moroccan people who are dealing with dementia. The official language used is Turkish or Moroccan-Arabic. In an Alzheimer Tea House, those involved meet each other in an informal atmosphere. They can share experiences and receive information in their own language”.  

breaking language barriers: enhancing clinical trial accessibility

Being able to discuss these illnesses in a trusted environment and a safe haven of your own culture has proven successful in terms of diverse clinical trial participation and retention. What if all life sciences companies prior to setting up the sites and recruiting trial patients, would study the feasibility of such an approach for the drugs that they want to research for the ultimate purpose of proving the efficacy of that drug for the most appropriate patients?

Next, as part of our “CQ Life Sciences In-Depth” blog series, we like to address other clinical trial recruitment challenges, related to e.g.  geographical restrictions, financial implications, as well as the lack of accessibility due to limited language skills or literacy levels.

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