The commentary that I wrote in JAMA referred to a Lin et al paper, really, that looked at a systematic evaluation, systematic review of clinical trials over 20 years. And it was astounding the kind of results that they showed in terms of representation, right? So over 90% of people in clinical trials were non-Hispanic whites. And they don’t even report any kind of racial ethnic categorizations...
The commentary that I wrote in JAMA referred to a Lin et al paper, really, that looked at a systematic evaluation, systematic review of clinical trials over 20 years. And it was astounding the kind of results that they showed in terms of representation, right? So over 90% of people in clinical trials were non-Hispanic whites. And they don’t even report any kind of racial ethnic categorizations. And we say it’s problematic because the research field and different bodies have said, oh, no, you should report this. Because, again, these are individuals or groups that have the highest burden of this disorder. So I think it’s essential to understand that including other racial ethnic groups and reporting on racial ethnic groups is important because these minoritized communities are the ones that bear the highest burden. It’s also important when we look at the science, there are racial differences in terms of APOE4, in terms of cardiovascular or cardiometabolic burden, these are established risk factors that impact Alzheimer’s disease outcomes, or dementia outcomes. So when you don’t have everybody really represented properly, then you are creating a situation where a physician who is now meant to treat people, because you have a higher prevalence of these disorders among these individuals, right? So in certain places, you’re going to have those people sitting in front of the physician. But the treatment decisions are being made with data that is not necessarily representative. And there are other factors that we can learn from a racially diverse and inclusive population that can help inform the science, help us have better science. So I think that’s so important. So now part of the challenges has always been the restrictive criteria in terms of eligibility and inclusion into clinical trials. Again, because with a clinical trial, you want the cleanest of people to be sure that your intervention really makes an impact. And so that’s understandable. However, it’s important not just efficacy, but, the effectiveness is important in the general population. So we think that trials should, at least to a reasonable extent, be less restrictive because you have people with vascular comorbidities or pathologies excluded. And then you’re going to exclude a whole lot of people who really are the at-risk individuals, right? And so I think that’s important. The community engagement aspect, it’s important to gain trust in these communities. And the people that are working in that field, in that space, clinical trialists need to partner with such people so that they can help, because they’ve built trust, they have the stakeholders and representation and be able to bring people into those studies. Otherwise, I don’t think that the excuses will stand at this time, especially since we understand the heterogeneity of the disease and how different sociocultural context and even ancestral genetic influences and heterogeneity impact the disease process, progression, response to treatment, and even outcomes.
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