BETA-What disparities exist in clinical trial enrollment? Why is it important to have African Americans represented in clinical trials?

What disparities exist in clinical trial enrollment? Why is it important to have individuals of African-American descent represented in clinical trials? Oh, that's my favorite question. The enrollment of people with misuse in clinical trials. So the FDA several years ago had said that it is really difficult to assume that the results of a clinical trial are pertinent to everybody unless people of diverse populations are involved in clinical trials. One thing that I stress to our fellows who are in training for HEMOC is that when you paper on myeloma, is a patient in front of you reflected in the patient in that paper. Because if the patients in that paper aren't the same as the patient in front of you, you don't know if that paper is applicable to that patient. So we need to enroll diverse populations in clinical trials. One thing that the FDA saw between 2009 and 2017 was that the enrollment of myeloma patients for FDA approved drugs or drugs to be approved by the FDA was only 4.5%. Very low enrollment. 80 to 90% were Caucasian. Only 4.5% were people of African descent. If you look at the United States, the number of African Americans that have myeloma in the United States makes up about 20% of the myeloma population. But only 5% are enrolled in those clinical trials. So how can I know that a particular drug will work for my patients and only 5% of African Americans are involved in that? How do I know it will work for everybody? So it's important to have a diverse population in clinical trials and know that these drugs work. Because if it doesn't work for one group, it doesn't work for all groups, then you can't cure myeloma unless you cure everybody. And so enrolling diverse populations gives us more information. It gives us more closer to that cure, closer to those excellent treatments when we enroll diverse populations. And so to get that number from 5% to 25%, you look at the Emory. Again, Emory has done such a good job in enrolling people who have been in clinical trials. The determination trial that took place throughout the United States with RVD transplant versus RVD without transplant enrolled a huge number of people of African descent. So we're getting a lot better at enrolling diverse populations in clinical trials. But we need to do it for all of our trials to get more people involved. So the European, Europeans and the clinical trials there, we hope will enroll more diverse populations in their clinical trials so we know these drugs work for everybody. So in terms of clinical trials for the Black myeloma population, I think even without thinking about myeloma itself, we first have to kind of take a broader lens and ask who is actually enrolling in clinical trials more generally. And we see that nationally, if you look across all cancer types, that Black patients continue to be underrepresented. They represent only about 7% of those who are enrolled in clinical trials. And that number is pretty similar for myeloma, especially myeloma-related trials. So we need to have African Americans or Black patients represented in trials because this is a way for us to truly tell if these therapies that have been tested in other populations are as effective in the African American or Black community. Also, we need to remember that in the real world, when we're giving these drugs, if we haven't tested them in that particular demographic, it makes it really hard to understand what is the true effect of these particular therapies within the African American or Black community. So allowing us to study the direct effects, that really helps when Black patients or the African American community really can engage and participate in medical research. So in terms of disparities that exist in clinical trials, some of those include not presenting clinical trials upfront as a treatment option for many patients of minority backgrounds, and also recognizing that some of the eligibility criteria for clinical trials do prohibit some of these patients of being likely to participate. And so we really need to revamp the way we've done things and really kind of focus on some of these areas to recognize that, you know, if you are going to create a clinical trial protocol, you really need to be mindful of, well, what are the medications that we are attempting to use in this clinical trial protocol? And what are the true eligibility criteria? Do we really need to have certain organ dysfunctions set at a certain level, or are we just doing that because that's what we've always done? And I think what we've always done clearly isn't working and hasn't worked best for everyone. And so we really need to look at those areas because those are very easily fixable areas. African American representation in clinical trials is very important because as it stands right now, you know, less than 5% of patients in many clinical trials across the board are African Americans. You will find individual clinical trials that do a much better job, and that's great. If you are utilizing a clinical trial in order to have a medication or treatment regimen approved, then it needs to be reflective of the population in its entirety. And so if you are only representing a subset of the population and it doesn't reflect the true, you know, diversity of the population at large, then you really are boxing out, a subset of individuals. And so how do we really know if the biology of the disease in that group is going to respond the same way as the medications respond in the group that did receive it in the clinical trial? And so the applicability of the treatment and the outcome is important, and you're only going to get that information if you include everyone, and that representation matters. And so we really need to look at those areas because those are very easily fixable areas that can be changed in real time.